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   April 2007 News Archive news archive  


02/04/2007  IMPAX Settles Oxycontin Litigation; Amends Marketing Agreement with DAVA Pharmaceuticals news archive
HAYWARD, Calif.--(BUSINESS WIRE)--Apr 2, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the Company has signed an agreement with Purdue Pharma L.P. and certain of its affiliates to settle patent infringement litigation pertaining to IMPAX's generic versions of Purdue's Oxycontin(R) (oxycodone HCI controlled-release) Tablets....
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02/04/2007  Purdue Pharma L.P. Announces Agreement to End OxyContin Patent Lawsuit with IMPAX Laboratories news archive
STAMFORD, Conn., April 02, 2007 /PRNewswire/ -- Purdue Pharma L.P. of Stamford, Connecticut and IMPAX Laboratories, Inc. of Hayward, California have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin(R) (oxycodone HCl controlled-release) Tablets....
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02/04/2007  DAVA Released from Oxycodone Patent Liability and Continues as Exclusive Distributor news archive
FORT LEE, N.J., April 2, 2007 – DAVA Pharmaceuticals, Inc. announced today that under the terms of an agreement signed on March 30, 2007, between IMPAX Laboratories, Inc. and Purdue Pharma L.P. and certain of its affiliates to settle patent infringement litigation pertaining to IMPAX’s generic versions of Purdue’s Oxycontin® (oxycodone HCI controlled-release) Tablets, DAVA as well as its distributors and customers were granted a full release from liability related to the sale and distribution of the IMPAX manufactured oxycodone product....
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02/04/2007  Fitzpatrick Cella Wins Appeal on Behalf of Merck & Co. in Trusopt Dorzolamide Patent-Infringement Case news archive
NEW YORK, April 2, 2007 – Leading intellectual property law firm Fitzpatrick, Cella, Harper & Scinto announced that it won an appeal on behalf of client Merck against generic patent challenges by Hi-Tech Pharmacal Co. in a case involving glaucoma eye drug Trusopt® (dorzolamide HCl opthalmic solution)....
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03/04/2007  IMPAX Announces FDA Approval of Generic Corzide news archive
HAYWARD, Calif.--(BUSINESS WIRE)--Apr 3, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) ("IMPAX" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Applications (ANDA) for Nadolol/Bendroflumethiazide 40mg/5mg and 80mg/5mg, generic of Corzide(R)....
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03/04/2007  S&P;: Generic Pharma Finishes 2006 In Best Overall Position Ever, Report Says news archive
NEW YORK April 3, 2007--The generic drug industry closed out an eventful 2006 with a solid quarter and entered 2007 in probably its strongest position ever, according to Standard & Poor's Ratings Services' report titled "Reflections On Generic Pharma: Fourth-Quarter 2006 Review," published earlier today....
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03/04/2007  Generic Cholesterol Drugs Vital to Helping Consumers, Nation Lower Health-Care Costs news archive
/PRNewswire-USNewswire/ -- As the maker of Lipitor reportedly urges doctors to carefully consider prescribing generics to lower cholesterol, Consumer Reports Best Buy Drugs reminds consumers that generic statins are as effective as high-priced brands for most people who need a statin drug, and can help consumers save more than $1,000 a year....
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03/04/2007  Thailand's Patent Damage news archive
By ROGER BATE, resident fellow of the American Enterprise Institute, is author of the paper, "Thailand and the Drug Patent Wars," recently published by the institute. Urged by Western activists, Thailand officials have started the latest, perhaps final, hostile campaign against Western medical patents. In a shortsighted move, which will save at most $24 million dollars, Thailand's military dictatorship is breaking patents on HIV and heart disease drugs...Other Asian governments are watching Thailand's actions, and also the actions of Western firms and investors. Thailand's patent-busting folly may be the last such attempt in Asia. Click here to read full story (External news site)...
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03/04/2007  Orchid receives Canadian TPD approval for two generic formulations news archive
/Orchid/ Chennai, India – April 03, 2007 -- The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid), today announced that it has received formal approval from the Canadian TPD (Therapeutic Product Directorate) for 2 of its ANDS (Abbreviated New Drug Submission) applications. These approvals correspond to two generic formulations, Cefoxitin and Ceftriaxone....
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04/04/2007  JSJ Pharmaceuticals Announces Authorized Generic Agreement news archive
CHARLESTON, S.C., April 04, 2007 /PRNewswire/ -- JSJ Pharmaceuticals is pleased to announce that, as part of its long-term brand life cycle management, it has reached an agreement with an undisclosed generic pharmaceutical partner to provide authorized generic versions of JSJ brands....
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06/04/2007  FDA Announces Tentative Approval of Generic Abacavir Sulfate Tablets news archive
ROCKVILLE, Md., April 6, 2007--The Food and Drug Administration, on April 5, 2007, granted tentative approval for abacavir sulfate tablets, 300 mg, manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR )....
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06/04/2007  Barr Confirms Patent Challenge of Ambien CR news archive
WOODCLIFF LAKE, N.J., April 06, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a patent challenge for Sanofi-Aventis U.S. LLC's Ambien CR(R) (Zolpidem Tartrate Extended-Release Tablets), 6.25mg & 12.5mg....
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06/04/2007  Abbott Ups the Ante in Thailand Patent-Breaking news archive
/PatentBaristas/ -- Abbott Laboratories announced that it will not launch new medicines in Thailand in response to the military-installed government’s decision not to honor the company’s patent for an AIDS drug.  On January 29th 2007 the Thai Ministry of Public Health announced that it would issue compulsory licenses for Kaletra and for Plavix, an anti-platelet medication that reduces the risk of unstable blood clots in people with heart disease....
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07/04/2007  Congress Seeks Compromise on Generic Drugs news archive
NYTimes - WASHINGTON, April 7 — Senior members of Congress from both parties are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year. Click here to read full story (External news site)...
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09/04/2007  Patent and Trademark Office Issues Notice of Allowance on Barr's Reissue Application for Seasonale '032 Patent news archive
WOODCLIFF LAKE, N.J., April 09, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Patent and Trademark Office (PTO) has issued a Notice of Allowance for the reissuance of U.S. Patent 5,895,032 ('032), relating to Barr's SEASONALE(R) extended-cycle oral contraceptive....
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09/04/2007  GeoPharma, Inc. Closes $12.5 Million Debt and Equity Financing news archive
LARGO, Fla., April 9 /PRNewswire-FirstCall/ -- GeoPharma, Inc. (Nasdaq: GORX - News) - GeoPharma announces today that it closed a $12.5 million debt and equity financing with a single institutional investor. Proceeds of the funding will be used to strengthen the Company's cash position, support sterile injectable and other ongoing generic pharmaceutical expansion including plant infrastructure, equipment expansion, research and development and related generic drug working capital needs....
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09/04/2007  Pfizer and Mylan Fight to Defend Norvasc Against Generics news archive
/SeekingAlpha/ -- Aaron F. Barkoff submits: A dozen companies have submitted letters in response to FDA's March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues. Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for generic Norvasc besides Mylan's (MYL).

Meanwhile, the district court has allowed (pdf file) Teva (TEVA), Apotex and Mutual to intervene in the case for the limited purpose of responding, if necessary, to Mylan's motion for a temporary restraining order against FDA.

In its March 29 request for comments (pdf file), FDA presented the following questions:

Click here to read full article (External news site)...
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10/04/2007  U.S. District Court Grants Extension for Consideration of Amlodipine Besylate Exclusivity news archive
/PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. District Court for the District of Columbia has extended the deadlines pertaining to Mylan's request for a temporary restraining order in its lawsuit seeking to stop the U.S. Food and Drug Administration (FDA) from approving any other Amlodipine Besylate abbreviated new drug applications (ANDAs)....
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10/04/2007  Boca Pharmacal Receives FDA Approval for Generic Version of Panlor SS news archive
CORAL SPRINGS, Fla.--(BUSINESS WIRE)--Apr 10, 2007 - Boca Pharmacal, Inc. made two major announcements today with the U.S. Food and Drug Administration granting its final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of and Panlor(R)SS (Acetaminophen, Caffeine and Dihydrocodeine) and the signing of an exclusive marketing and distribution agreement with Tedor Pharma Inc. for Didrex(R) (Benzphetamine Hydrochloride). Boca Pharmacal also announced that the company plans to launch both products immediately....
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10/04/2007  Endo Comments on Notices Received From Anesiva news archive
CHADDS FORD, PA -- (MARKET WIRE) -- April 10, 2007 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), announced today that it received notice from Anesiva, Incorporated, advising of the filing of a New Drug Application (NDA) under 21 U.S.C. § 355(b)(2)(A)(iv) (also referred to as Section 505 (b)(2)(A)(iv) of the Federal Food, Drug and Cosmetic Act) for its Zingo™ Dermal PowderJect Lidocaine HCl topical powder and referring to the patents that cover the method of use and formulation of Endo's lidocaine-containing topical patch products, Lidoderm® and Synera™. ...
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10/04/2007  Abbott Laboratories ABT Agrees With World Health Organization Director-General to Expand Access to Kaletra/Aluvia lopinavir/ritonavir news archive
/PRNewswire-FirstCall/ -- Abbott and World Health Organization (WHO) Director-General, Margaret Chan, have agreed on a balanced approach to provide Kaletra/Aluvia (lopinavir/ritonavir) capsules and tablets to more patients in the developing world, while supporting continued long-term biopharmaceutical research and development....
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10/04/2007  Abbott Lowers Price Of Kaletra AIDS Drug news archive
Pharmalot -- The drugmaker has agreed to lower the cost to $1,000 per patient per year in more than 40 low- and middle-income countries, as defined by World Bank criteria. This includes India, Brazil and China. And Abbott will "immediately begin discussions with countries where (its) patents are respected" to increase the number of patients who can obtain Kaletra at the new price. Click here to read full story (External news site)...
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10/04/2007  Indian Govt asks Novartis to withdraw patent challenge news archive
NEW DELHI (Reuters) - The government is "very concerned" that a challenge by Swiss drug giant Novartis AG to local patent law could restrict the global supply of cheap anti-AIDS drugs, the health minister said on Tuesday. Novartis has gone to the Madras High Court in Chennai against a law that blocks the patenting of minor improvements in known molecules. India is a key source of cheap generic medicines, and advocacy groups worry that millions of poor people could lose access to key drugs if Novartis succeeds in its challenge. Click here to read full story (External news site)...
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10/04/2007  India’s biotech industry emerging as a world innovator news archive
/Newswise/ -- India’s health biotech firms are emerging as a major global player, with growing means and know-how to produce innovative as well as generic drugs and vaccines at costs small relative to those of giant Western firms, according to ground-breaking Canadian research. Published April 9 by Nature Biotechnology, the authors say their study of 21 home-grown firms sheds unprecedented public light on India’s private sector biotech efforts... Click here to read full story (External news site)...
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10/04/2007  Ranbaxy, Jupiter Bioscience enter into marketing tie-up news archive
TIMES NEWS NETWORK - MUMBAI: Ranbaxy Laboratories is about to enter into a 10-year co-marketing agreement with Jupiter Bioscience to tap the $6-billion global peptide pharmaceutical market. The specialised organic compounds manufacturer will initially licence out to Ranbaxy Lab five generic peptide drugs in anti-cancer, anti-diuretic, osteoporosis and growth hormones segments, worth $3 billion at innovator’s prices... Click here to read full story (External news site)...
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11/04/2007  OrangeBookBlog Reminder: ACI's Paragraph IV and Pharmaceutical Antitrust Conferences Are Approaching news archive
This is just a quick reminder of two upcoming conferences from ACI that should be of interest to Orange Book Blog readers: "Paragraph IV Disputes" and the "3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust."...
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11/04/2007  Simcere Pharmaceuticals, NovaCardia, and Quark Biotech File for IPO's news archive
/PatentDocs Blog/ -- On March 23, 2007, Simcere Pharmaceuticals filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering of its common stock.  According to a MarketWatch report, the Chinese generic drug maker is seeking to raise $120 million in the IPO.  Simcere's shares will be listed on the New York Stock Exchange under the symbol "SCR."...
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11/04/2007  PatentDocs Blog Court Report: April 08, 2007 news archive
About PatentDocs Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. This week: Bayer Healthcare AG et. al. v. Teva Pharmaceuticals U.S.A., Inc. 1:07-cv-00195; filed April 5, 2007 in the District Court of Delaware Sanofi-Aventis et. al. v. Barr Laboratories Inc. 2:07-cv-01605; filed April 5, 2007 in the District Court of New Jersey ...
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11/04/2007  Senate Democrats to force GOP hand on drug talks news archive
/AP - WASHINGTON/ -- Democrats will soon renew efforts to let the government negotiate drug prices on behalf of Medicare participants. Senate Majority Leader Harry Reid, D-Nev., said Tuesday the Senate will turn its attention to the new drug benefit once it finishes with a bill that would loosen federal funding restrictions on stem cell research. While prospects for the drug legislation are uncertain, it would require Republican senators to take a stand on government negotiations - a concept that has broad popular support. Click here to read full article (External news site)...
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11/04/2007  Ranbaxy Receives Approval To Market Cefprozil Tablets and Cefprozil Powder For Oral Suspension in Canada news archive
TORONTO, April 11 /CNW/ -- Ranbaxy Pharmaceuticals Canada Inc. (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that Ranbaxy has received approval to manufacture and market RAN(TM)-Cefprozil Tablets, 250mg and 500mg, and RAN(TM)-Cefprozil Powder for Oral Suspension, 250mg/5mL from Health Canada. The total market size for Cefzil(TM)(*) in Canada was CAD 28.2 million dollars (IMS-MAT: Dec 2006)....
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11/04/2007  India - ‘Don’t force us to issue compulsory licence on Gleevec news archive
/The Financial Express/ NEW DELHI, APR 10 -- In a veiled threat to Swiss pharmaceutical major Novartis to withdraw the case the company had filed after being denied patent on its cancer drug Gleevec, Union health minister Anbumani Ramadoss on Tuesday said that the company should not force the government to issue a compulsory licence... Click here to read full story (External news site)...
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12/04/2007  District Court Calls for GlaxoSmithKline to Release Fluticasone Launch Bond of $3 Million to Roxane Laboratories news archive
COLUMBUS, Ohio, April 10, 2007 /PRNewswire/ -- Roxane Laboratories, Inc. today announced that on April 6, 2007 the district court of Maryland ordered that the $3 million dollar bond posted by GlaxoSmithKline be released to Roxane. GSK was ordered to post the bond over a year ago when it filed a lawsuit against the FDA following the FDA's approval of Roxane's fluticasone propionate its generic equivalent to FLONASE(R)(1)....
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12/04/2007  National Center for Policy Analysis: Dr. Waxman's Drug Lab news archive
Biopharmaceuticals, or biologics, are proteins made by splicing genetic material into living cell cultures. Many biologics are breakthrough therapies, from Avastin, which chokes off the blood supply to cancerous tumors, to Cerezyme, which treats the rare genetic disorder Gaucher's disease. These drugs are expensive: Some can run to thousands of dollars a year. According to IMS Health, the total cost reached $52.7 billion in 2005, some 13 percent of U.S. drug spending. That figure is expected to rise to $90 billion by 2009. California Rep. Henry Waxman has introduced the Access to Life-Saving Medicine Act because, he claims, all this is "too expensive." Click here to read full article (External news site)...
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12/04/2007  Biogenerics Bill - Paradox or idiocy? news archive
/Health Business Blog/ -- A bill to allow biogenerics continues working its way through Congress. According to the New York Times (Congress Seeks Compromise on Generic Drugs) "Prospects for the legislation have increased since Democrats took control of Congress this year. Consumer groups, employers and insurers are lobbying for the bill, which they see as a way to hold down health costs." - The article rehashes the usual issues that I’ve outlined repeatedly:... Click here to read full article (External news site)...
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13/04/2007  AstraZeneca sues Novartis over Quetiapine news archive
/DelawareOnline/ April 11, 2007 -- AstraZeneca PLC has filed suit in federal district court in Trenton to block rival drug maker Novartis AG's Sandoz unit from selling a generic version of Seroquel, AstraZeneca's drug for schizophrenia and bipolar disorder. Click here to read full story (External news site)...
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13/04/2007  U.S. Court Affirms Judgment for Allergan against Apotex in Ketorolac Lawsuit news archive
IRVINE, Calif., Apr 12, 2007 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) announced today that the United States Court of Appeals for the Federal Circuit has affirmed a favorable ruling for Allergan against Apotex (the "Defendants") preventing the Defendants from obtaining U.S. Food and Drug Administration approval to market a generic version of Allergan's product ACULAR(R) (ketorolac tromethamine ophthalmic solution) 0.5%...
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13/04/2007  Global IP Strategy Update: IP freedom to operate put simply™, with the 6T’s™ framework news archive
/Duncan Bucknell/ -- Phase 1 – preparing for and conducting the search: How confident are you that your next product launch or commercial innovation does not infringe anyone else's intellectual property rights? The fact that you're reading this article suggests that you are well aware that this is universally a bad (and usually expensive) mistake to make....
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13/04/2007  Federal Circuit Expands the Ability of Generic Drug Companies To Sue Pioneer Drug Companies For Declaration Of Patent Noninfringement And Invalidity news archive
/Mondaq/ 11 April 2007 -- A new Federal Circuit decision promises to lead to more patent suits between generic drug companies and pioneer drug companies. Following the Supreme Court's explicit direction in its MedImmune v. Genentech opinion, the Federal Circuit has overturned its prior restrictive test for the right of generic drug companies to bring declaratory judgment actions against pioneer drug companies. In Teva v. Novartis, issued March 30, 2007, the Federal Circuit has opened the door more widely for generic drug companies that wish to establish certainty regarding patent rights... Click here to read full story (External news site)...
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13/04/2007  Abbott Tries New Approach to Kaletra/Aluvia Pricing news archive
/PatentBaristas/ 12 April 2007 -- After Abbott Laboratories announced that it would not launch new medicines in Thailand in response to the military-installed government’s decision not to honor the company’s patent for its AIDS drug, the company has now announced a new plan....
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13/04/2007  WTO FAQs: Compulsory licensing of pharmaceuticals and TRIPS news archive
/World Trade Organisation/ -- A certain amount of confusion exists about the TRIPS Agreement’s provisions and compulsory licensing for medicines. These are some answers to questions that are frequently asked....
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13/04/2007  Lannett Acquires Bulk Raw Materials Supplier news archive
PHILADELPHIA--(BUSINESS WIRE) April 12, 2007 --Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced it has acquired a privately-owned manufacturer/supplier of bulk active pharmaceutical ingredients (API). Financial terms of the agreement were not disclosed....
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13/04/2007  Biotech IPO Watch: Simcere Supplies High-End Generics In China news archive
/SeekingAlpha/ Apr 12th, 2007 -- Centient Biotech Investor submits: Simcere Pharma (SCR) of China, a company that bills itself as a maker of branded generic drugs for the domestic (Chinese) market, has filed to make its IPO and list on the NYSE. The company focuses on first-to-market generics, including an anti-stroke drug and an anti-cancer medication. The Simcere portfolio of drugs has high margins, because they treat serious diseases or are in high demand... Click here to read full story (External news site)...
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16/04/2007  Mylan Announces Final FDA Approval for Glipizide and Metformin Hydrochloride Tablets news archive
PITTSBURGH, April 13, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Glipizide and Metformin Hydrochloride Tablets in 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths....
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16/04/2007  CCPM Applauds Letter from Bipartisan Group of Governors Urging Congressional Action on Biogenerics news archive
WASHINGTON, April 13 /PRNewswire-USNewswire/ -- Coalition for a Competitive Pharmaceutical Market (CCPM) Chair Annette Guarisco issued the following statement in support of Governors' letter on biogenerics:...
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16/04/2007  Sen. Clinton's Support for Generic Biotech Drug Legislation Could Deter Republicans, Lobbyists Say news archive
/Kaisernetwork/ Apr 13, 2007 -- Lobbyists for legislation that would allow FDA to approve generic versions of biotechnology medications have raised concerns that the support of Sen. Hillary Rodham Clinton (D-N.Y.) "might inadvertently be helping to repel" Republicans, who "don't want to hand Clinton a victory on something she could tout on the campaign trail,"... Click here to read full story (External news site)...
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16/04/2007  A.U. Health Ministers Receive Plan To Produce Low-Cost, Generic Drugs in Africa news archive
/Kaisernetwork/ Apr 12, 2007 -- African Union health ministers on Wednesday at a three-day summit in Johannesburg, South Africa, were presented with a plan for developing low-cost generic versions of drugs -- including treatments for HIV/AIDS, malaria and tuberculosis -- on the continent, AFP/Yahoo! News reports. Many African countries currently import low-cost generic drugs from India and China, but both countries are subject to patent laws, which could restrict Africa's access to the medicines, according to AFP/Yahoo! News... Click here to read full story (External news site)...
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16/04/2007  German Court invalidates drug dosage patent news archive
/IPGeek/ March 20 2007 -- Germany's highest court, the Bundesgerichtshof rendered its decision in the Carvedilol II case. Subject of the decision of the Federal Court of Justice was the validity of a patent claim containing a specific dosage instruction for Carvedilol. The Federal Court of Justice revoked the claim and underlined that a specific dosage instruction for the use of drugs should be seen as a non-patentable method for treatment of the human body....
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17/04/2007  Patent Docs Blog: Court Report - April 15 news archive
/Patent Docs/ April 15, 2007 -- Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. This week:
Teva v Cobalt - Sertraline
AstraZeneca v Sandoz - Quetiapine
Merck v Teva - Montelukast...
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17/04/2007  District Court Dismisses Merck's Fosamax Suit Against Apotex, Despite Apotex's Opposition news archive
/Orange Book Blog/ April 15 2007 -- A year ago, Merck sued Apotex alleging that Apotex's ANDA for generic Fosamax infringed nine patents on pharmaceutical formulations of alendronate, the active ingredient in Fosamax.  Apotex answered with counterclaims of patent invalidity and noninfringement.  Then, after Merck reviewed portions of Apotex's ANDA, Merck granted Apotex a covenant not to sue on the patents and filed a motion to dismiss for lack of subject matter jurisdiction.  Last week, the U.S. District court for the District of Delaware granted the motion.

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17/04/2007  Prasco and Graceway Pharmaceuticals Sign a Distribution and Supply Agreement for Authorized Generic Version of Metronidazole news archive
CINCINNATI--(BUSINESS WIRE)--Apr 16, 2007 - Prasco Laboratories, a Cincinnati-based pharmaceutical company, announced today it has entered into a distribution and supply agreement with Graceway Pharmaceuticals, LLC. for an authorized generic version of MetroGel-Vaginal Gel (metronidazole vaginal gel, 0.75%)....
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18/04/2007  Hi-Tech Pharmacal Receives Tentative Approval for Ciclopirox Topical Solution news archive
AMITYVILLE, N.Y.--(BUSINESS WIRE)--Apr 17, 2007 - Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8%....
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18/04/2007  Lobbyists Seek To Slow Legislation That Would Allow Generic Biotech Drugs news archive
/KaiserNetwork/ Apr 16, 2007 -- Pharmaceutical and biotechnology industry lobbyists are seeking to slow the passage of a bill that would permit the marketing of generic biotechnology drugs, which they argue are too complex to approve without first conducting clinical trials, the Boston Globe reports (Henderson, Boston Globe, 4/16)... Click here to read full article (www.kaisernetwork.org)...
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18/04/2007  Generics biz of Merck to cost winner over $6b news archive
/Times News Network/ 17 Apr, 2007 -- AHMEDABAD: With the bid for German pharma giant Merck's generics business now entering the final lap with the due diligence reaching a crucial stage, it's emerging that the big ticket acquisition could cost the winning bidder over $6 billion. According to sources, the final binding bids are to be submitted by the end of this month... Click here to read full article (www.indiatimes.com)...
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18/04/2007  FTC Requires Sale of Generic Drug Assets in Actavis - Abrika Deal news archive
/AP/ April 16, 2007 -- WASHINGTON — Two pharmaceutical companies agreed to sell the rights to a blood pressure drug to a third company in order to secure regulatory approval to merge, a federal agency said Monday. The Federal Trade Commission said that Iceland-based Actavis Group HF and Sunrise, Fla.-based Abrika Pharmaceuticals Inc. agreed to sell certain rights and assets related to a generic drug known as isradipine in order to satisfy the FTC's competition concerns... Click here to read full article (www.chron.com)...
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18/04/2007  Drugmakers to take earnings medicine - Generic competition plays prominent role in results news archive
NEW YORK (CNNMoney.com) -- This is a big week for the U.S. drug industry's earnings, with mixed results expected from a slew of brand-name drugmakers that carry a common theme: getting squeezed by the loss of blockbuster products. Big Pharma's first-quarter earnings per share "will be a mixed bag, with some still suffering the blows of new generic competition," wrote Barbara Ryan, analyst for Deutsche Bank North America, in a published note... Click here to read full article (money.cnn.com)...
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18/04/2007  Lobbyists take aim at generic biologics; Stakes high in debate over regulatory bill news archive
/The Boston Globe/ April 16, 2007 -- ...Pharmaceutical and biotechnology industry lobbyists trying to slow passage of the legislation are getting help from a few well-placed friends of industry. In congressional hearings, the most vocal opponents have been echoing concerns expressed by the powerful industry lobbies: To ensure patient safety, these newest generic products must undergo clinical trials before Food and Drug Administration approval. They also argue that clinical trials may be needed after approval to make clear whether a branded product or a generic is responsible for side effects that crop up... Click here to read full article (www.boston.com)...
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18/04/2007  Brazil’s market for bioequivalent generics ranks among the world’s top ten news archive
· Patents expiring between 2007 and 2013 offer lucrative opportunities. · ANVISA has recently authorised generic production of oral contraceptives & hormones. · Brazil needs to locally produce APIs to strengthen generics production & exports. · Public-private partnerships are being fostered for bioequivalent production. Brazil has a market for bioequivalent generics valued at US$1.5 billion at retail prices in 2007. The generics market is expected to continue to increase between 2007 and 2012, but at a relatively more moderate pace. Pharmacy sales of bioequivalent generics increased by 52.2% in US dollar values in 2006, reaching over US$1.0 billion for the first time....
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19/04/2007  New Study Reveals Generic Drugs Continue Entering Market as Authorized Generic Competition Increases news archive
/PhRMA/ WASHINGTON, April 18, 2007 – According to a new study by researchers at the Massachusetts Institute of Technology’s (MIT) School of Management and Analysis Group Inc., there is no evidence that the recent increase in prevalence of authorized generics has resulted in delays in generic entry into the marketplace. This report reinforces findings in a separate study that authorized generics increase competition and lower prices for consumers. ...
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19/04/2007  GPhA Statement on Senate Committee Markup of FDA Reform Bill news archive
ARLINGTON, Va., April 18, 2007 /PRNewswire-USNewswire/ -- The Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger today made the following statement regarding the U.S. Senate Health, Education, Labor and Pensions Committee's markup of Food and Drug Administration (FDA) reform legislation:...
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19/04/2007  Analysis Group Releases Report on Impact of Authorized Generic Entry on Paragraph IV Certifications news archive
BOSTON--(BUSINESS WIRE)--Apr 18, 2007 - Analysis Group, a leading provider of economic, financial, and business expertise to law firms, corporations, and government agencies, today released a self-published report entitled, "Do Authorized Generic Drugs Deter Paragraph IV Certifications? Recent Evidence."...
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19/04/2007  Thailand Will Maintain Compulsory Licenses for Kaletra, Efavirenz, Despite Companies' Drug Price Reductions news archive
/Kaisernetwork/ Apr 16, 2007 -- Thailand will maintain compulsory licenses for Abbott Laboratories' antiretroviral drug Kaletra and Merck's antiretroviral Efavirenz, despite both companies' decision to reduce the cost of both drugs, Thai Health Minister Mongkol Na Songkhla said on Thursday, Reuters Health reports (Wong-Anan, Reuters Health, 4/12)... Click here to read full article (www.kaisernetwork.org)...
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19/04/2007  OrangeBook Blog: Follow-on Generic Biologics News news archive
/OrangeBook Blog/ April 17, 2007 -- A number of interesting news reports concerning follow-on biologics have been published in recent days. Links to full articles included: "Hopes for Speedy Action on Generic Biologics Fade in Senate"--Biologic Drug Report 4/16/07, "Lobbyists Take Aim at Generic Biologics"--Boston Globe 4/16/07, "Senate HELP Panel to Review Comprehensive FDA......
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19/04/2007  Legal Network releases 13-point plan to Parliament to fix Canada’s Access to Medicines regime news archive
/AIDSlaw/ OTTAWA, April 18, 2007 — In a detailed brief to the House of Commons Standing Committee on Industry, Science and Technology released today, the Canadian HIV/AIDS Legal Network called on Ottawa to take concrete steps to fix Canada’s Access to Medicines Regime and get affordable drugs to people in developing countries who desperately need them. ...The cornerstone of the 13 recommendations in the Legal Network’s brief is a proposal to authorize any pharmaceutical firm to produce generic versions of any drug patented in Canada for export to any eligible developing country listed in the law... Click here to read full PDF article (www.aidslaw.ca)...
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19/04/2007  Canadian organizations seek amendments to allow production of generic drugs for export news archive
/Globe and Mail/ April 18th 2007 -- OTTAWA — Three years after Jean Chrétien said Canada would allow generic drug makers to send copies of brand-name medicines to poor countries to combat diseases such as AIDS and malaria, groups that follow the issue say not a single pill has left Canada. But the groups argue that Canada's Access to Medicines Regime can be rewritten to get the drugs moving... Click here to read full article (www.theglobeandmail.com)...
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23/04/2007  FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets news archive
PITTSBURGH, April 18, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan's current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets. The FDA notified Mylan and all amlodipine besylate ANDA applicants that all of the unapproved amlodipine besylate ANDAs are currently blocked from approval by pediatric exclusivity...
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23/04/2007  GPhA Calls PhRMA's Authorized Generics Study 'Disingenuous' news archive
ARLINGTON, Va., April 18, 2007 /PRNewswire-USNewswire/ -- The Generic Pharmaceutical Association (GPhA) today called PhRMA's latest study on "authorized generics" a disingenuous attempt to devalue the 180-day exclusivity period, which is an important incentive for generic pharmaceutical companies to challenge questionable patents and bring affordable medicines to market....
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23/04/2007  Abbott Wins Preliminary Injunction Against Sandoz in Biaxin XL Case news archive
/Orange Book Blog/ April 19, 2007 -- This past Monday, Judge David H. Coar of the U.S. District Court for the Northern District of Illinois granted Abbott's motion for a preliminary injunction to stop Sandoz from selling a generic version of Biaxin XL (clarithromycin extended release tablets). ...
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23/04/2007  Abraxis BioScience Receives FDA Tentative Approval for Fosphenytoin Sodium Injection news archive
LOS ANGELES--(BUSINESS WIRE)--Apr 19, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that it has received a tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fosphenytoin Sodium Injection...
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23/04/2007  Zydus receives tentative approval for Losartan Potassium tablets news archive
Zydus Cadila has received tentative appropval for Losartan Potassium Tablets in the strengths of 25mg, 50mg and 100mg for the US FDA. THe branded sales of Losartan Potassium Tablets, which falls in the anti-hypertensive segment, is estimated at USD 817 million in 2006 as per NDC Health....
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23/04/2007  Zydus Cadila buys Nippon Pharma news archive
/Business Standard/ Ahmedabad April 20, 2007 -- Zydus Cadila is strengthening its base in Japan, the world’s second largest pharma market. The company on Thursday acquired 100 per cent stake in Nippon Universal Pharmaceutical, a privately held company headquartered in Tokyo... The Japanese generics market is valued at $3 billion and has tremendous growth potential, as it currently stands at 5 per cent of the total pharma market in Japan in value terms and 17 per cent by volume. Click here to read full article (www.business-standard.com)...
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23/04/2007  DOJ official elaborates on 'reverse payments' news archive
WASHINGTON (MarketWatch) Apr 19, 2007 -- A senior Department of Justice official Wednesday publicly disagreed with recent statements by Federal Trade Commissioner J. Thomas Rosch that payments by pharmaceutical companies to generic drug makers should be illegal. The payments, known as reverse payments, are made by pharmaceutical companies to generic drug makers as their patent on a particular drug is coming to an end, in order to persuade the generic makers to keep out of the market for that drug... Click here to read full article (www.marketwatch.com)...
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23/04/2007  FDA Refuses to Approve Any ANDAs for Generic Norvasc Besides Mylan's--For Now news archive
/Orange Book Blog/ April 18, 2007 -- Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer's last remaining unexpired patent on Norvasc--U.S. Patent No. 4,879,303--Pfizer, Mylan and other ANDA filers have been scrambling. On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic....
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24/04/2007  Prasco Enters into Agreement with sanofi-aventis to Market the Authorized Generic Versions of Ambien Zolpidem Tartrate CIV news archive
CINCINNATI--(BUSINESS WIRE)--Apr 23, 2007 - Prasco announced today it has signed a distribution and supply agreement with sanofi-aventis U.S. to launch authorized generic versions of Ambien(R) in the United States. The authorized generic Zolpidem Tartrate will be marketed in 5 mg and 10 mg strengths....
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24/04/2007  Mylan Announces Final FDA Approval and Immediate Shipment of Zolpidem Tartrate Tablets news archive
PITTSBURGH, April 23, 2007 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets, 5 mg and 10 mg. This product is being shipped immediately....
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24/04/2007  Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to Market Generic Ambien news archive
DETROIT, April 23, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets....
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24/04/2007  Express Scripts' Workers' Compensation Program Increases Use of Generic Drugs news archive
ST. LOUIS--(BUSINESS WIRE)--Apr 20, 2007 - ExpressComp, a workers' compensation offering by Express Scripts, increases the use of generic medications and reduces clients' costs. Express Scripts is one of the largest pharmacy benefit managers (PBM) in North America. ExpressComp's Physician Outreach Program (POP) is a clinical-based module designed to encourage physicians and injured workers to consider using generic alternatives when appropriate....
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24/04/2007  For Now, Mylan Remains Sole Generic Norvasc Seller news archive
/Patent Baristas Blog/ April 23rd, 2007 -- Mylan Laboratories has announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan’s current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets....
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24/04/2007  Patent Docs Blog: Court Report - April 23rd news archive
Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. This week includes: PDL Biopharma vs Sun Pharmaceutical (nicardipine), MedPointe vs Apotex (azelastine), Exela vs Allergan (brimonidine)...
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24/04/2007  Facing Reality on Follow-On Biologics news archive
/AEI Online/ April 24, 2007 -- HEALTH POLICY OUTLOOK: New and highly sophisticated biotech drugs called biologics have enjoyed unprecedented success in fighting disease. The law does not provide a way to create generic versions of these complex and expensive drugs after patents expire. This reflects current science, as generics in the traditional sense of bioequivalence are practically impossible. Congress, however, appears poised to create a regulatory pathway for "follow-on biologics." This would involve reduced testing requirements while granting the Food and Drug Administration (FDA) wide discretion on exactly what to require. There is no reason to expect a reasonable follow-on biologic law to bring dramatic cuts in health-care spending as claimed. But unless Congress is careful, it will interrupt long-term drug research programs and reduce incentives to develop new biologics. Click here to read full article (www.aei.org)...
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24/04/2007  Federal Circuit Affirms Invalidity of AstraZeneca Prilosec Process Patent news archive
/Orange Book Blog/ April 23, 2007 -- In a 2-1 decision released today, the Federal Circuit affirmed a 2004 district court decision finding AstraZeneca's U.S. Patent No. 6,013,281 invalid as inherently anticipated. The '281 patent covers a process for making Prilosec, Astra's blockbuster anti-ulcer medication....
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24/04/2007  Actavis completes acquisition of Abrika Pharmaceuticals in the US news archive
/Actavis/ 23.04.2007 -- Actavis Group announces the successful completion of its acquisition of Abrika Pharmaceuticals Inc., a US based specialty generic pharmaceuticals company engaged in the formulation and commercialization of both controlled release ("CR") and other technically difficult pharmaceutical products. The Company will be consolidated into Group accounts from mid April 2007....
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26/04/2007  Brazil declares Efavirenz to be of public interest news archive
The Brazilian Minister of Health, José Gomes Temporão, has signed a decree published today in the Federal Official Gazette declaring the antiretroviral drug Efavirenz to be of public interest. ...The declaration is the first step towards the compulsory licensing of the patent for public non-commercial use. ...The measure has been taken because the Merck laboratory, owner of the Efavirenz patent, did not accept a price reduction proposal that was satisfactory for Brazil, one of the world’s biggest buyers of the drug. ...
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26/04/2007  Ranbaxy Receives US FDA Approval To Manufacture And Market Pravastatin Sodium Tablets In USA news archive
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Pravastatin Sodium Tablets (Pravastatin), 10 mg, 20 mg, 40 mg and 80 mg, with 180 day market exclusivity in the U.S. healthcare system for the 80 mg strength....
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26/04/2007  Dr. Reddy's Announces the Launch of Zolpidem Tartrate Tablets news archive
HYDERABAD, India--(BUSINESS WIRE)--Apr 25, 2007 - Dr. Reddy's Laboratories (NYSE:RDY) today announced that the Company has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets, 5 mg and 10 mg. This product is being shipped immediately....
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26/04/2007  Roxane Laboratories Announces Launch Of Zolpidem Tartrate Tablets news archive
/Roxane/ COLUMBUS, OH - April 23, 2007- Roxane Laboratories, Inc. today announced the launch of Zolpidem Tartrate Tablets CIV, 5mg and 10mg. The product will be available in bottles of 100 and 500, as well as a 100 count Unit Dose package....
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26/04/2007  Teva Introduces Zolpidem Tartrate Tablets, CIV news archive
NORTH WALES, Pa., April 23, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Zolpidem Tartrate Tablets, CIV....
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26/04/2007  Lannett Company Receives Approval for Danazol news archive
PHILADELPHIA--(BUSINESS WIRE)--Apr 23, 2007 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Danazol Capsules 50mg and 100mg....
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26/04/2007  FDA grant tentative approval of generic stavudine to Matrix Laboratories news archive
/PEPFAR/ ROCKVILLE, Md., April 23, 2007-FDA granted tentative approval on April 23, 2007 for a generic formulation for stavudine capsules, 30 mg and 40 mg, manufactured by Matrix Laboratories Limited of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR)...
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26/04/2007  U.S. approves 13 generic versions of sleep drug Zolpidem news archive
WASHINGTON (Reuters) Tue Apr 24, 2007 -- U.S. health officials have approved 13 cheaper generic alternatives to Ambien, a blockbuster sleeping pill from France's Sanofi-Aventis, the Food and Drug Administration said on Monday... Click here to read full article (www.reuters.com)...
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26/04/2007  Federal Circuit Affirms Invalidity of AstraZeneca Prilosec Process Patent news archive
/Orange Book Blog/ April 23, 2007 -- In re Omeprazole Patent Litigation (Fed. Cir. 2007) In a 2-1 decision released today, the Federal Circuit affirmed a 2004 district court decision finding AstraZeneca's U.S. Patent No. 6,013,281 invalid as inherently anticipated. The '281 patent covers a process for making Prilosec, Astra's blockbuster anti-ulcer medication....
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26/04/2007  Recognizing a Novel Characteristic After the Fact Doesn’t Make a Known Composition New Again news archive
/Patent Baristas Blog/ April 24th, 2007 -- In 2001, AstraZeneca filed suit in the US against against several pharmaceutical companies that were seeking permission from the Food and Drug Administration (FDA) to market generic versions of Prilosec, Astra’s gastric acid inhibiting drug, for infringement of a patent directed to a process for making an omeprazole formulation....
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26/04/2007  Patently at Odds - Drug and Tech Sectors Battle With Reform High on Agenda news archive
/Washington Post/ April 18, 2007 -- Two of the country's leading industries, computer technology and drug manufacturing, are battling over an effort by Congress to overhaul the way inventors profit from ideas, with executives on both sides saying billions of dollars are at stake. ...In resisting some of the major rewrites being discussed in Congress, the pharmaceutical industry points to the plight of Purdue Pharma, maker of the popular OxyContin painkiller, as an example. Purdue had filed suit against a generic drugmaker... Click here to read full article (www.washingtonpost.com)...
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26/04/2007  Purdue Pharma Tries to Salvage 30-Month Stay in OxyContin Case Against Mallinckrodt news archive
/Orange Book Blog/ April 24, 2007 -- Purdue Pharma has been fighting in court for nearly a decade to protect OxyContin--a blockbuster painkiller and by far Purdue's best-selling drug product--from generic competition. Purdue settled its patent litigation with Endo and Teva last year, and with Impax a few weeks ago. Recently, Purdue filed complaints against Mallinckrodt and KV Pharma. Purdue's case against Mallinckrodt is particularly interesting, since it raises some new questions about 30-month stays....
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27/04/2007  Alchemia Limited appoint new marketing and manufacturing partner for synthetic heparin - generic fondaparinux sodium news archive
/Alchemia/ 26 April 2007 -- Australian drug development company Alchemia Limited (ASX: ACL) today announced the appointment of Dr Reddy’s Laboratories Limited (NYSE: RDY) as its marketing partner for synthetic heparin (fondaparinux sodium). Alchemia has granted Dr Reddy’s the exclusive rights to market its synthetic heparin in North America, with first right of refusal to market the product in the European Union once GlaxoSmithKline’s branded product, Arixtra®’s market exclusivity expires in 2012...
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27/04/2007  Kennedy Circulates Biogenerics Bill news archive
/Pharmalot Blog/ April 25, 2007 -- Ted Kennedy is reported to be circulating draft legislation which would provide an approval pathway at the FDA for generic versions of biotech drugs. His proposed bill would also provide a period of market exclusivity for brand-name biotechs before generic versions of their products could come to market. Click here to read full article (pharmalot.com)...
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27/04/2007  Authorized generics: the contentious issue of competition news archive
/Pharmaceutical Business Review/ 25th April 2007 -- While opinion regarding the competitive impact of authorized generics is mixed, a new report from analysts at MIT suggests that they may actually promote competition. The issue will be further clarified by the US competition watchdog, in a decision that will affect generic manufacturers and drug developers alike. Click here to read full article (www.pharmaceutical-business-review.com)...
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27/04/2007  OrangeBook Blog: Pharma News Briefs news archive
/Orange Book Blog/ April 25, 2007 -- Links to six news articles of interest including: authorised generics, Abbott vs Thailand, biologics/biogenerics, reverse payments...
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27/04/2007  Novartis sues India on patents [Summary article] news archive
/The Manila Times/ April 26, 2007 -- ...India became the “pharmacy of the world’s poor” in 1970 when it stopped issuing drug patents, allowing its many drug producers to create generic copies of medicines still patent-protected in other countries—at a fraction of the price charged by multinational drug behemoths. In 1994, however, New Delhi became signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (Trips), a deal which required all WTO member countries to grant patents on technological products, including pharmaceuticals, by 2005. This prompted drug firms to queue up to patent their brands in India. Up to 9,000 patents await examination. Glivec was one of the first to go to court... Click here to read full article (www.manilatimes.net)...
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30/04/2007  Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Nimotop news archive
DETROIT, April 27 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today that it will market Nimodipine Capsules, 30mg (Nimotop(R)) on behalf of Sun Pharmaceutical Industries, Inc. Sun recently received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Nimodipine....
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30/04/2007  Synovics Pharmaceuticals Forms Strategic Alliance with Harcharan [Harry] Singh news archive
PHOENIX--(BUSINESS WIRE)--Apr 27, 2007 - Synovics Pharmaceuticals, Inc., (OTCBB:SYVC), a specialty pharmaceutical company, today announced that it has formed a strategic alliance with Harcharan (Harry) Singh, who is the President and CEO of Glopec International, a privately held international trading and investment company based in Ontario, Canada....
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30/04/2007  Actavis Launches Zolpidem Tablets in the U.S. news archive
/Actavis/ Totowa, NJ, 27 April 2007 -- Actavis today announced that Carlsbad Technology, Inc. (CTI) has received approval of its ANDA for Zolpidem Tartrate tablets from the U.S. Food & Drug Administration. Actavis will market the product under an agreement with CTI in the United States. Distribution of the product will commence immediately....
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30/04/2007  Time Is Running Out for Generic Biotech news archive
/Associated Press/ WASHINGTON, April 26, 2007 -- Generic drug makers may fail again this year to get a bill passed that would let them market cheaper versions of biotech drugs, some of the most expensive medicines on the market. The Senate is expected to vote next week on the one major pharmaceutical bill expected to pass this year, and the odds are growing that the biotech generics issue won't be included... Click here to read full article (www.chron.com)...
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30/04/2007  Patent Docs Blog: Court Report - April 29, 2007 news archive
/Patent Docs Blog/ April 29, 2007 -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. This week: Wyeth v. Osmotica Pharmaceutical Corp (Venlafaxine)...
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30/04/2007  Decision pending on Merck KGaA generics, bids due news archive
FRANKFURT, April 27 (Reuters) - German drugs and specialty chemicals group Merck KGaA (MRCG.DE: Quote, Profile, Research has not yet made a final decision on selling its generic-drug business but a divestment makes sense, Chief Executive Michael Roemer said on Friday. Click here to read full article (www.reuters.com)...
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30/04/2007  Organon Starts Legal Proceedings In Portugal In Defence Of Livial news archive
27 Apr 2007 Organon will today open legal proceedings against the suppliers of two drugs for infringement of its chemical purity and particle size patents for tibolone. The action will be filed in Portugal, where the infringements are alleged to have occurred....
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30/04/2007  Patents Are For Chumps: Brazil & Efavirenz news archive
/Patent Baristas/ April 27th, 2007 -- Who Doesn’t Want to Save on Heathcare? - In a week of thumbing noses at patents, Brazil said it will buy a generic version of a Merck’s efavirenz anti-retroviral drug for the treatment of AIDS unless it offers Brazil a deeper discount on the medicine. Health Minister Jose Gomes Temporao signed a decree declaring a “public interest” medicine” the first step in a process that could lead Brazil to break Merck’s patent....
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30/04/2007  Schering-Plough files patent infringement action on Zetia news archive
/MarketWatch/ Apr 27, 2007 -- Schering-Plough Corp. (SGP) said Friday it and an entity it owns jointly with Merck & Co. Inc. (MRK) filed a patent infringement action against companies seeking to get Food and Drug Administration approval for a generic version of Zetia. Click here to read full article (www.marketwatch.com)...
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30/04/2007  Mylan, Apotex, and Teva File Motions Challenging FDA's Decision on Generic Norvasc news archive
/Orange Book Blog/ April 26, 2007 -- Apparently not too many companies other than Pfizer are happy with the FDA's decision last week regarding Norvasc (amlodipine besylate) exclusivity. On Monday, Mylan, Apotex, and Teva all filed motions with the U.S. District Court for the District of Columbia for injunctive relief from FDA's decision. Today, everyone filed briefs in opposition to each others' motions....
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30/04/2007  Hatch May Soon Introduce Compromise Bill on Biotech Generics news archive
/Congressional Quarterly/ April 25, 2007 -- Sen. Orrin G. Hatch, R-Utah, said Wednesday that he is likely to introduce a bill soon aimed at striking a compromise on the issue of bringing generic versions of biotech drugs to market. But the move may not come in time for Senate floor action next week on a prescription drug bill (S 1082), widely viewed as must-pass legislation this year. Speaking at a forum sponsored by the U.S. Chamber of Commerce, Hatch said... Click here to read full article (public.cq.com)...
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