Generics Industry News Search
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July 2007 News Archive |
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/Patent Docs/ In this week: Astrazeneca v. Teva (quetiapine); Smithkline Beecham v. Mylan (paroxetine); Glaxo v. Cypress (ranitidine); MedPointe v. Sun (azelastine); Wyeth v. Sandoz (venlafaxine); Otsuka v. Teva (aripiprazole); Teva v. Lupin & Moehs & Orchid & Urquima & Wanbury & Zhejian & USV & Cadila & Ranbaxy & Dr. Reddy's & Watson & Mylan & Taro(Carvedilol) ...
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WOODCLIFF LAKE, N.J., July 2 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that Gedeon Richter, Plc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Novartis Pharmaceutical Corporation's LAMISIL(R) (terbinafine hydrochloride) Tablets...
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PITTSBURGH, July 2 /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 Terbinafine Hydrochloride (HCl) Tablets, 250 mg (base)....
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COLUMBUS, Ohio, July 2 /PRNewswire/ -- Roxane Laboratories, Inc. announced today that they received approval for its Abbreviated New Drug Application (ANDA) for Terbinafine Hydrochloride Tablets, 250mg by the U.S. Food and Drug Administration....
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/Orange Book Blog/ July 02, 2007 -- Update of the Hatch-Waxman Tracker...
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/Patent Docs/ July 02, 2007 -- Valeant Pharmaceuticals International announced today (July 2, 2007) that it has settled its patent infringement suit with Kali Laboratories, Inc. (which was acquired by Par Pharmaceutical in June of 2004). Valeant's patent infringement action involved Diastat®, which Valeant markets as the only FDA-approved at-home acute treatment for break-through epileptic seizures....
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Mumbai, July 02, 2007: Glenmark Pharmaceuticals Ltd. [Glenmark], a research-based pharmaceutical company headquartered in Mumbai (India) received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets in multiple strengths (25 mg, 50 mg, 100 mg and 200 mg)....
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JERUSALEM-- (BUSINESS WIRE) -- Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) to market Terbinafine Hydrochloride Tablets, 250 mg (base), the AB-rated generic equivalent of Novartis’ antifungal agent Lamisil® Tablets. Shipment of this product will begin immediately....
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HAWTHORNE, N.Y.-- (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. (“Taro,” PINK SHEETS: TAROF) reported today that it has received final approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Terbinafine Hydrochloride Cream 1% (“terbinafine cream”)....
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DETROIT, July 3 /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 paroxetine hydrochloride tablets, USP (Paroxetine HCl)....
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/Patent Baristas/ July 3rd, 2007 -- In Takeda v. Alphapharm and Genpharm (06-1329), The U.S. Court of Appeals for the Federal Circuit upheld an earlier decision in the district court finding that U.S. Patent 4,687,777 was not invalid under 35 U.S.C. § 103. Takeda Chem. Indus., Ltd. v. Mylan Labs., 417 F. Supp. 2d 341 (S.D.N.Y. 2006). Earlier, Takeda invented certain thiazolidinediones (TZDs)... Click here to read full article (www.patentbaristas.com)...
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/Astrid Spain/ 03 July 2007 -- With three judges filing dissenting opinions, the U.S. Court of Appeals for the Federal Circuit denied Pfizer’s petition for rehearing and rehearing en banc of its April 2007 decision finding a new salt form of a composition obvious in view of the prior art and holding that a motivation to combine references can be gleaned from the nature of the problem to be solved. Pfizer Inc. v. Apotex, Inc., Case No. 06-1261 (May 21, 2007)
Click here to read full article (www.mondaq.com)...
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/US Pharma Technologist/ 03/07/2007 - South Korea is to inject about one trillion won ($1.07bn) into its pharmaceutical industry to give it a rev up as the newly signed free trade agreement (FTA) with the US comes into force. The North Asian country's pharmaceutical industry, which is mostly dependent on generics production, is, according to reports, anticipated to be hit hard by the agreement, which will see innovative US pharmaceuticals flooding the South Korean market as restraints on the imports are removed and regulatory processes made more transparent... Click here to read full article (www.outsourcing-pharma.com)...
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Mumbai, July 3, 2007: Glenmark Pharmaceuticals Ltd. [Glenmark], a research-based pharmaceutical company, headquartered in Mumbai (India), has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications (ANDAs) for Terbinafine Hydrochloride Tablets, 250 mg (base)....
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Hyderabad, July 3, 2007 -- Aurobindo Pharma Limited is pleased to announce that the Company has received approval from the US FDA for Terbinafine Hydrochloride Tablets 250 mg. This approval is received on the first day after the expiry of the relevant patent....
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/Patent Docs/ July 04, 2007 -- Last Thursday, the Federal Circuit upheld a judgment from a District Court that Defendant-Appellant Alphapharm Pty., Inc. had failed to prove invalidity and unenforceability of claims 1, 2, and 5 of U.S. Patent No. 4,687,777 (the '777 patent).
Click here to read full article (patentdocs.typepad.com)...
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/Orange Book Blog/ July 5, 2007 -- Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., No. 05-1492 (Fed. Cir. 2007) - In a decision that appears to diminish the value of pharmaceutical formulation patents, today the Federal Circuit held that "[a]n equivalent is foreseeable if one skilled in the art would have known that the alternative existed in the field of art as defined by the original claim scope, even if the suitability of the alternative for the particular purposes defined by the amended claim scope were unknown."...
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/Patent Docs/ July 05, 2007 -- Last week, the U.S. Senate Committee on Health, Education, Labor & Pensions announced that it had passed the Biologics Price Competition and Innovation Act. According to a Committee press release, the bill (S. 1695) "includes standards for the FDA to approve follow-on biologics, a procedure designed to help resolve patents in an expedited way, and strong but responsible incentives to encourage innovation and the development of new therapies."...
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/Thomson Financial/ 07.05.07 LONDON -- The Department of Health (DoH) is caught up in a row with the pharmaceuticals industry over its policy of encouraging doctors to switch patients onto cheaper generic drugs. The Association of the British Pharmaceuticals Industry (ABPI) has won a judicial review to challenge the scheme, which the DoH says would save the National Health service 84 mln stg. The DoH accused the ABPI of trying to 'control commercial activities'... Click here to read full article (www.forbes.com)
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SAN DIEGO, July 6 /PRNewswire/ -- Brandes Investment Partners, L.P. ("Brandes") is an SEC-registered investment adviser headquartered in San Diego, California. Brandes managed $125 billion on behalf of institutional and individual investors, as of June 30, 2007. Brandes has acquired for and on behalf of its clients approximately 10.8% of the shares outstanding for Taro Pharmaceuticals Inc....
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EDISON, N.J., July 06, 2007 /PRNewswire/ -- Heritage Pharmaceuticals Inc. ("Heritage") and Granules India Ltd. ("Granules") announced today that they have entered in to a strategic alliance for the development, supply and marketing of generic pharmaceutical products for the U.S. prescription drug market....
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/Orange Book Blog/ July 07, 2007 -- Pharma news briefs, as collected by Aaron Barkoff...
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WOODCLIFF LAKE, N.J., July 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary Barr Laboratories, Inc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Pharmacia and Upjohn Company's Dostinex(R) (cabergoline) tablets...
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COLUMBUS, Ohio, July 9 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration...
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/Orange Book Blog/ July 09, 2007 -- Scherago International has announced "Biosimilars 2007," a two day conference to "air the issues" and "raise the questions" associated with biosimilars (also called follow-on biologics or biogenerics). The conference will be held September 24-25 in the Jack Morton Auditorium on the campus of George Washington University, in Washington D.C...
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/Patent Docs/ July 09, 2007 -- A measure of sanity returned last week, when the Brasilian Health Ministry and Abbott Laboratories announced an agreement on a pricing regime for Abbott's anti-AIDS drug, Kaletra®. Under this agreement, Brasil will not "break" Abbott's patent by permitting sale or importation of a generic version of the drug....
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/Patent Docs Blog/ In this week: Purdue v. Par (Tramadol); Daiichi Sankyo v. Mylan (olmesartan)...
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MORRISTOWN, N.J., July 09, 2007 /PRNewswire/ -. Actavis Group (OMX: ACT), the international generic pharmaceuticals company, today announced that it has launched Terbinafine hydrochloride tablets in the U.S. Distribution of the product will commence immediately....
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/FDC Reports/ July 09, 2007 -- Hansenpharm Co. began selling generic versions of Lilly's blockbuster antipsychotic Zyprexa (olanzapine) in China this month after winning a groundbreaking lawsuit against Lilly late last year. The court battle lasted five years and marked the first time that a Chinese company won a patent case against a major multinational pharmaceutical company...
Click here to read full article (fdcalerts.typepad.com)...
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LONDON, July 9 /PRNewswire/ -- Apotex UK Ltd, the British arm of Canada's largest generics manufacturer, today announced that it had won a patent dispute, allowing the company to launch its generic version of the popular ACE Inhibitor, perindopril to the NHS....
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PRINCETON, N.J., July 10 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Amlodipine Besylate Tablets...
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/Patent Docs/ July 10, 2007 -- On Monday, ARIAD Pharmaceuticals, Inc. announced that the U.S. District Court for the District of Massachusetts had ruled in its favor in a patent infringement suit ARIAD filed against Eli Lilly and Co....
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NORTH WALES, Pa., July 10, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Amlodipine Besylate Tablets. This product is AB rated and bioequivalent to Norvasc®* Tablets. ...
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NEW YORK--(BUSINESS WIRE)--Jul 10, 2007 - Pfizer Inc said today that the High Court in Dublin, Ireland has ruled that the basic patent covering atorvastatin - the active ingredient in Lipitor - would be infringed by a competitor product from generics manufacturer Ranbaxy. The decision, which is subject to a possible appeal, prevents Ranbaxy from launching its drug before the basic Lipitor patent (Irish Patent Number 60014) expires in November 2011....
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DETROIT, July 11 /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 Atenolol Tablets USP (atenolol)....
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/Orange Book Blog/ July 11 2007 -- In a nonprecedential opinion released today, the Federal Circuit reversed a district court decision that held Daiichi Sankyo's U.S. Patent No. 5,401,741 not invalid for obviousness. The '741 patent claims a method for treating bacterial ear infections by topically administering the antibiotic ofloxacin (marketed by Daiichi as Floxin Otic solution, 0.3%). Apotex had filed an ANDA for generic Floxin Otic, certifying under Paragraph IV that the '741 patent is invalid....
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ROCKVILLE, Md., July 11, 2007--FDA granted tentative approval on July 10, 2007 for a generic formulation of nevirapine tablets, 200 mg, manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. of Zhejiang China, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief...
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/Yomiuri Shimbun/ 11 July 2007 Japan -- The government, aiming to lessen the budgetary burdens of health care, plans to double the use of generic medicines--drugs that are no longer protected by patents--by the end of fiscal 2012. Encouraging wider use of generics has repercussions for the pharmaceutical industry. The plan, if realized, would reduce the market for newly developed medicines to the tune of nearly 1 trillion yen a year ... Generic medicine manufacturers, by contrast, have drawn rosy pictures for the future... Click here to read full article (www.yomiuri.co.jp)...
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/Business Standard/ New Delhi July 11, 2007 -- The first-to-file advantage in the US was the big dream Indian pharmaceutical firms were chasing for the last few years. It gave them 180-day exclusivity to market the generic version of a drug after its patent expired. With Indian firms holding these rights for blockbuster drugs such as Pravastatin (worth $209 million), Simvastatin ($513 million) and Ondanseteron ($639 million), it was projected that these would see sharp jump in turnover. However, most Indian pharmaceutical companies find that global drug firms which hold the patents for most of these drugs have punctured their dream with authorised generics - cheaper variants produced by firms “authorised” by them... Click here to read full article (www.business-standard.com)...
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WOODCLIFF LAKE, N.J., July 12, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Boehringer Ingelheim in connection with its Aggrenox(R) (Aspirin/Extended- Release Dipyridamole) 25 mg/200 mg capsules....
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PHILADELPHIA--(BUSINESS WIRE)--Jul 12, 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) for its Abbreviated New Drug Application (ANDA) for Baclofen 10mg tablets, bolstering the company's existing product offering of Baclofen 20mg tablets....
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/The Court/ July 12th, 2007 -- On Thursday, July 5, 2007, the SCC granted the application for leave to appeal in the case of Apotex Inc. v. Sanofi-Synthelabo Canada ... On April 28, 2003, Sanofi-Synthelabo Canada Inc. and Sanofi-Synthelabo commenced an application in the Federal Court. The application sought an order to prohibit the Minister of Health from issuing a Notice of Compliance (”NOC”) to Apotex ... with respect to its 75 mg clopidogrel bisulfate tablets until 2012, the expiration of Sanofi’s ‘777 Patent. Click here to read full article (www.thecourt.ca)...
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LONDON, July 12 (Reuters) - The market for generic drugs in Europe will double over the next six years as an ageing population and rising healthcare costs drive demand for cheaper medicine, according to a forecast released on Thursday. Consulting group Frost & Sullivan estimated the European generics market would grow to $35.9 billion in 2013 from $17.18 billion in 2006 with the expirations of patented drugs also helping to fuel the increase... Click here to read full article (investing.reuters.co.uk)
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/Patent Docs/ July 13, 2007 -- The measure of sanity displayed by Abbott and Brasil last week, when the parties agreed to a pricing scheme that avoided "breaking" Abbott's patent on its anti-AIDS drug Kaletra® (see "Brasil Prevails in Dispute with Abbott over AIDS Drug Pricing") has not translated to the Eastern hemisphere....
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/Patent Docs/ July 13, 2007 -- On Wednesday, the Federal Circuit reversed a District Court judgment that U.S. Patent No. 5,401,741 (the '741 patent) was not invalid. In particular, the Federal Circuit held that the District Court clearly erred in determining the level of one of ordinary skill in the art, and as a result, erred in finding the '741 patent valid as nonobvious....
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CEDEX, France, July 13, 2007--Ethypharm has signed a new licensing agreement with the Merck Generique laboratory for the marketing of Buprenorphine. Thus, Merck is Ethypharm's second marketing partner for this product in France. The product was launched on April 25th 2007....
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/Orange Book Blog/ July 15, 2007 -- Links to news in Pharma, collected by Aaron Barkoff...
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/Patent Docs/ July 15, 2007 -- In this week: Boehringer v. Barr (dipyridamole), Wyeth v. Mylan (venlafaxine), Sanofi-Aventis v. Actavis & Pharmachemie & Abraxis & Mustafa & Ebewe (oxaliplatin)...
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WOODCLIFF LAKE, N.J., July 16, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Sepracor Inc. in connection with its Xopenex(R) (Levalbuterol Hydrochloride) 0.31mg/3mL, 0.63mg/3mL and 1.25mg/3mL....
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EXETER, N.H.--(BUSINESS WIRE)--Jul 16, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced the receipt of two product approvals in Europe. The Company's subsidiaries in Spain, Laboratorios Belmac, Laboratorios Davur and Laboratorios Rimafar, received product approval for venlafaxine ...The Company's subsidiary in Ireland, Bentley Pharmaceuticals Ireland Limited, has received approval for alendronate...
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/Patent Docs/ July 16, 2007 -- The crisis in global drug pricing that has arisen since the institution of the World Trade Organization (WTO), and in particular with regard to the Doha Declaration ... is well-recognized. While the international community has not been able to address the resulting disruptions in expectations, for both innovator drug companies and citizens of the developing world, proposals are beginning to emanate from academic commentators....
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/Patent Docs/ July 16, 2007 -- As we reported yesterday, last week the United States Patent and Trademark Office (USPTO) posted 48 submissions it received in response to a solicitation for comments on international patent law harmonization. Among those submitting comments were...
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BALTIMORE, July 17, 2007 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). Commercial shipments of Amlodipine Besylate Tablets will commence shortly....
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jul 17, 2007 - Akorn-Strides, LLC today announced its first ANDA approval for Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL....
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/Patent Docs/ July 17, 2007 -- There may be some good news with regard to the safety of generic drugs obtained from China. Despite recent evidence that the U.S. Food and Drug Administration has been woefully deficient in inspecting generic drug manufacturers overseas (see "The Effect of Foreign Generics on the U.S. Drug Supply - Part I") and instances of contaminated excipients obtained from overseas manufacturers appearing in a variety of pharmaceutical products (see "The Effect of Foreign Generics on the U.S. Drug Supply - Part II"), it is possible that the situation is less dire when it comes to prescription drugs....
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/Forbes/ 17 July 2007 LONDON - Generic drugs were both a gift and a curse for Swiss pharmaceutical company Novartis on Tuesday, when the company announced its financial results for the second quarter of 2007. Although revenues hit double-digit growth thanks in part to sales from Novartis's generic manufacturing division, the company's outlook for the rest of the year has turned queasy because of competition from generics against its branded drugs... Click here to read full article (www.forbes.com)...
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/PubPat/ New York, NY -- July 18, 2007 -- The Public Patent Foundation ("PUBPAT") announced today that the U.S. Patent & Trademark Office has granted each of PUBPAT's requests to review four key HIV/AIDS drug patents held by Gilead Sciences, Inc. (NASDAQ: GILD). The patents relate to the drug known generically as tenofovir disoproxil fumarate (TDF), a key weapon in the battle against HIV/AIDS. Gilead markets TDF in the United States under the brand name VIREAD and as a part of its ATRIPLA combination product....
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/Forbes/ 18 July 2007 -- This morning, Pfizer, the world's largest drug maker, posted earnings and sales that fell far short of the predictions of Wall Street analysts as cholesterol drug Lipitor, the company's crown jewel and the top-selling medicine in the world, lost ground to cheaper generic rivals. Click here to read full article (www.forbes.com)...
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Hyderabad, July 18, 2007 -- Aurobindo Pharma Limited is pleased to announce that the Company has received approval from the US FDA for Amlodipine Besylate Tablets 2.5 mg, 5 mg & 10 mg. This is Aurobindo’s fifth anti-hypertensive approval from US FDA....
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WOODCLIFF LAKE, N.J., July 19, 2007 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced it has entered into a settlement and license agreement with Ortho-McNeil Pharmaceutical, Inc. that resolves patent litigation related to Ortho-McNeil's Ultracet(R) product, thereby eliminating the inherent uncertainty and costs of litigation....
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PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Jul 19, 2007 - Beijing Med-Pharm Corporation (Nasdaq:BJGP) today announced that it has signed an exclusive license agreement with Shanghai Ethypharm Pharmaceutical Co., Ltd., a subsidiary of the French drug delivery company Ethypharm, under which Beijing Med-Pharm will market and distribute ondansetron Flashtab(R) (4 and 8 mg) in the People's Republic of China....
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/Pharmalot/ 19 July 2007 -- The fragile support for a Senate bill that would allow the FDA to approve generic versions of biologic drugs is deteriorating at the same time House lawmakers are trying to persuade leaders not to allow for such a provision in an FDA bill.Generic and brand name lobbyists say generic makers miight threaten to pull their support for the bill if a provision they say would give brand companies continuous monopoly rights is not changed, Congress Daily reports (subscription required)...
Click here to read full article (www.pharmalot.com)...
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DETROIT, July 20, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Modafinil Tablets (modafinil), 100mg and 200mg....
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Chennai, India – July 20, 2007 -- The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received approval from the US FDA for its ANDAs (Abbreviated New Drug Application) for Cefdinir for Capsules 300 mg and Cefdinir for Oral Suspension 125 mg/5 ml and 250 mg/5 ml.
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/Patent Docs/ 22 July 2007 -- By Sherri Oslick -- 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. In this week: Ortho-McNeil v. Apotex (Tramadol); UCB v. Cobalt (levetiracetam); Sepracor v. Barr (levalbuterol); Novartis v. Dr. Reddy's (amlodipine); ...
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MERIDIAN, Idaho, July 23 /PRNewswire-FirstCall/ -- Southridge Technology Group, Inc. announced that its wholly owned operating subsidiary, RxElite Holdings, Inc., a developer, manufacturer, and marketer of specialty generic prescription drug products, reports its successful launch of the modern generic anesthetic, Sevoflurane (trade name Sojourn(TM)), and targets a $400M US market opportunity....
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/Patent Docs/ July 23, 2007 -- Last month, the European Medicines Agency (EMEA) released a paper entitled "Questions and Answers on biosimilar medicines (similar biological medicinal products)," in which the EMEA provided answers to a number of questions concerning the authorization of biosimilars. The European biosimilar regulatory pathway was established in 2004. In view of recent attempts by Congress to enact biosimilar legislation ... the EMEA paper is informative....
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/Patent Docs/ July 23, 2007 -- Ortho-McNeil, Inc. announced late last week that it has settled its lawsuit against Par Pharmaceutical Companies, Inc. and its subsidiaries, Par Pharmaceutical, Inc. and Kali Laboratories, Inc., over the patent covering Ortho's Ultracet® (tramadol hydrochloride and acetaminophen, used to treat acute pain)....
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/Times News Network/ 23 Jul, 2007 NEW DELHI: A Crucial bill making its way through the US Congress is set to give a new inexpensive option for Indian drug makers to attack the patents that give monopoly rights to top-selling MNC brands in the largest pharmaceutical market. The bill passed by the judiciary committees of the House and the Senate last week, for a sweeping overhaul of the US patent system, allows an interested party to invalidate patents outside a court of law. They could approach the US Patent and Trademark Office (USPTO) for this after the patent is issued... Click here to read full article (economictimes.indiatimes.com)...
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/PharmaBiz/ Monday, July 23, 2007, Mumbai -- As part of its strategy to fight out generics copies of the leading high blood pressure medicine, Lotrel, the Novartis Corp. has filed patent infringement litigation against the Hyderabad based Dr Reddy's Laboratories in the US District Court for the District of New Jersey. The US drug major has filed complaint against the generic drug companies including Teva pharmaceuticals in 2004 against the Mumbai based Lupin in early 2007... Click here to read full article (www.pharmabiz.com)...
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WOODCLIFF LAKE, N.J., July 24, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed for Schering Corporation's TEMODAR(R) (Temozolomide) 5mg, 20mg, 100mg & 250mg capsules. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for TEMODAR....
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July 24 (Bloomberg) -- Sanofi-Aventis SA, Frances's biggest drugmaker, sued India's Sun Pharmaceuticals Industries Ltd. and Hospira Inc.'s Mayne Pharma unit to block generic competition to the colon cancer drug Eloxatin. ... In its complaints filed yesterday in federal court in Newark, New Jersey, Paris- based Sanofi seeks a court order barring regulatory approval until the patent it licenses expires in 2013. Click here to read full article (www.bloomberg.com)
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ARLINGTON, Va., July 25, 2007 /PRNewswire/ -- The Generic Pharmaceutical Association released the following statement correcting the misstatements about generic medicines discussed on NBC's Today Show:...
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BOCA RATON, Fla., July 25, 2007 /PRNewswire/ -- Breckenridge has entered into an agreement with Midland HealthCare LLC, Kansas City, KS. to develop and manufacture a liquid generic ANDA product. Breckenridge plans to file an ANDA with the FDA in late 2007. Upon approval by the FDA, Midland will manufacture and Breckenridge will market and distribute the product on an exclusive basis....
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PRINCETON, N.J., July 25, 2007 /PRNewswire/ -- Sandoz was pleased to learn this week that the U.S. Court of Appeals in St. Louis has affirmed a summary judgment by U.S. District Judge Rodney Sippel invalidating patent protection on Toprol XL(R), a beta blocker used to treat angina, heart failure, and high blood pressure....
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MONTREAL, July 25, 2007 /PRNewswire-FirstCall/ - DRAXIMAGE, the radiopharmaceutical division of DRAXIS Health Inc. , has taken another significant step in its product development strategy with the filing of its DRAXIMAGE(R) Sestamibi with European regulatory authorities. DRAXIMAGE(R) Sestamibi is a generic kit for the preparation of Tc-99m Sestamibi for injection, which is an imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart and is the largest radiopharmaceutical product in the nuclear medicine market segment.
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NEW YORK--(BUSINESS WIRE)--Jul 25, 2007 - Pfizer Inc said today that a Spanish court has upheld the company's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor. The Commercial Court of First Instance Number 4 in Barcelona, which issued the ruling, found a second patent covering a stabilized formulation that includes atorvastatin is invalid....
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/Orange Book Blog/ July 25, 2007 -- On Monday, the Federal Circuit affirmed a district court summary judgment decision that AstraZeneca's U.S. Patent No. 5,081,154 is invalid for double patenting. The '154 patent claims metoprolol succinate, the active ingredient in Astra's blockbuster cardiovascular drug Toprol-XL. KV Pharmaceutical, Andrx, and Eon Labs have all filed ANDAs for generic Toprol-XL and are defendants in the litigation....
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/Patent Baristas/ July 25th, 2007 -- ...In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four key HIV/AIDS drug patents held by Gilead Sciences Inc. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor and WARF’s stem cells.
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/Patent Baristas/ July 25th, 2007 -- AstraZeneca’s patent on Toprol-XL® was found invalid after the CAFC affirmed a district court’s invalidity holding based on double patenting but vacated the district court’s inequitable conduct holding and remanded the case to see if the patent and another one should be held unenforceable. In re Metoprolol Succinate Patent Litigation, United States Court of Appeals for the Federal Circuit, No. 06-1254....
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PRINCETON, N.J., July 26, 2007 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL) announced today that the Company has reached an agreement with GlaxoSmithKline (GSK) resulting in a dismissal of their U.S. litigation with regard to Valtrex(R) (Valacyclovir Hydrochloride tablets). The lawsuit in the U.S. was related to GSK's U.S. Patent No. 4,957,924, covering Valacyclovir Hydrochloride which is used in the treatment of herpes virus infection....
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ST. LOUIS, July 26 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it has begun shipment of its 100 mg and 200 mg strengths of metoprolol succinate extended release tablets. Based on the Company's first-to-file status on its ANDA for these two strengths, KV anticipates being accorded the benefit of a 180-day generic exclusivity period for the marketing of these two dosage strengths....
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WOODCLIFF LAKE, N.J., July 26 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced it has begun shipping metoprolol succinate extended release 100 mg and 200 mg tablets. ...
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/Motley Fool/ July 26, 2007 -- I'm pretty sure investors in Barr Pharmaceuticals (NYSE: BRL) have instituted a new motto for the company: "A lawsuit a week, that's all we ask." Coming off of two lawsuits filed against it in as many weeks, this week Barr announced that it was being sued again. This time it's drug maker Schering-Plough (NYSE: SGP) that's suing Barr over patent infringement of its brain cancer treatment drug, TEMODAR. Click here to read full article (www.fool.com)
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/Patent Docs/ July 26, 2007 -- Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) approved three new follow-on biologic drugs: Binocrit (Sandoz GmbH), Epoetin alfa Hexal (Hexal Biotech Forschungs GmbH), and Abseamed (Medice Arzneimittel Pütter GMBH & Co.)....
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/Patent docs/ Ranbaxy Laboratories Ltd. announced today (July 26, 2007) that it had reached an agreement with GlaxoSmithKline in which GlaxoSmithKline would dismiss its patent infringement suit against Ranbaxy. GlaxoSmithKline had asserted its U.S. Patent No. 4,957,924, directed to Valacyclovir Hydrochloride, against Ranbaxy, which received final approval to market a generic version of the drug from the FDA in early February 2007....
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HAYWARD, Calif.--(BUSINESS WIRE)--Jul 27, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. District Court for the District of Delaware has ruled that Aventis Pharmaceutical's patent 5,527,814 related to the use of Rilutek(R) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is not invalid on the grounds of anticipation....
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Jul 27, 2007 6:00 AM CDT - BUFFALO GROVE, Ill.-- (BUSINESS WIRE) -- Akorn, Inc. (NASDAQ:AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Over-the-Counter (OTC) use of Akorn’s Abbreviated New Drug Application (ANDA) for Ketotifen Fumarate Ophthalmic Solution, 0.025%.
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Monheim, July 27, 2007 – Bayer CropScience AG has successfully enforced the patent on imidacloprid (EP 0 192 060), its most successful insecticide worldwide, against Ki-Hara Chemicals Ltd., Birmingham, UK, and its Managing Director. The defendants, who unlawfully sold imidacloprid produced in China to customers in Middle East and Europe, but primarily in Almeria, Spain, were required to pay Bayer CropScience the sum of £225,000....
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/Orange Book Blog/ July 27, 2007 -- Links to Pharma news of interest, collected by Aaron Barkoff...
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/Patent Baristas/ July 27th, 2007 -- In a new paper “Confronting Myths and Myopia on the Road from Doha,” Daniel Cahoy, associate professor of business law at Penn State’s Smeal College of Business, looks at recent patent compulsory licenses issued by Thailand in terms of balancing access and innovation in essential medicines....
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/Patent Docs/ July 27, 2007 -- Scherago International, Inc. has organized the Biosimilars 2007 conference to be held on September 24-25, 2007 at George Washington University in Washington, D.C. The conference is intended to "air the issues" and "raise the questions" regarding legislation under consideration in Congress that would provide the Food and Drug Administration (FDA) with the authority to regulate biosimilars, as well as the application and use of biosimilars....
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/Patent Docs/ July 29, 2007 -- On July 23, 2007, the Federal Circuit affirmed by a 2-1 vote a District Court judgment that U.S. Patent No. 5,081,154 (the '154 patent) was invalid for double patenting. The Federal Circuit also vacated the District Court's holding that the '154 patent and U.S. Patent No. 5,001,161 (the '161 patent) were unenforceable based on inequitable conduct, and remanded the case....
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/Star-Ledger/ Sunday, July 29, 2007 WASHINGTON -- The Food and Drug Administration, beset by a lack of funding and staffing, is failing to keep up with the growing volume of generic drug applications and meet its obligation to approve the lower-cost prescription medicines in a timely fashion. Although the FDA gave the go- ahead to more than 500 generic drugs last year, the agency's backlog of pending applications grew to 1,291 last month, from 780 at the end of 2005... Click here to read full article (www.nj.com)...
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jul 30, 2007 - Akorn, Inc. (NASDAQ:AKRX) today announced the signing of a development and supply agreement with Hyaluron Contract Manufacturing, Inc. (HCM), an innovative leader in aseptic formulation and filling of liquid parenterals located in Burlington, Massachusetts. The Agreement provided for two ANDA injectable suspension products with a 2006 market size of approximately $220 million, according to IMS sales data....
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BALTIMORE, July 30 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that it received the award for "Best New Manufacturer of the Year, Generics Rx" from AmerisourceBergen, a leader in healthcare distribution in the US. The award is in recognition of Lupin's contribution and commitment toward excellence as a Generic drug supplier in the US....
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Gurgaon, Haryana, India - July 30, 2007 -- Ranbaxy Laboratories Limited (RLL), today announced the commercialization of its first Authorized Generic (AG) product, Isoptin® SR (Verapamil SR) in the US market, through its wholly owned subsidiary, Ranbaxy Pharmaceuticals Inc. (RPI), following an agreement with FSC Laboratories, Inc. of Charlotte, North Carolina, USA.
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/Patent Docs/ Jul 30, 2007 -- Integra Lifesciences v. Merck KGaA (Fed. Cir. 2007). In 2005, this case reached the Supreme Court – who held that the safe harbor created by 35 USC 271(e)(1) “exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission” to the FDA. ‘Reasonably related’ research is determined in a two-part test:...
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/The Economic Times/ 30 Jul, 2007 -- The Indian pharmaceutical industry has enjoyed the comfort of duplicating patented drugs for nearly four decades under the shelter of a Patents Act that only recognised process- based innovation. Today, this sector is challenged by a new patent regime that calls for new business strategies devoid of local protection to face global competition. Click here to read full article (economictimes.indiatimes.com)...
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/Patent Docs/ July 30, 2007 - By Sherri Oslick -- 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. In this week: Sanofi-Aventis v. Sun (oxaliplatin); Teva v. Zambon (Carvedilol); Cancer Research Technology v. Barr (temozolomide); Sepracor v. Glenmark (desloratidine); Infosint v. Forest (citalopram); Mayne v. Sanofi-Aventis (Oxaliplatin)...
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/Orange Book Blog/ July 30, 2007 -- Indian generic drug manufacturer Ranbaxy announced last week that the company has settled its litigation with GlaxoSmithKline over generic Valtrex. Ranbaxy received final FDA approval for its generic drug earlier this year. Under the agreement, the generic will launch in the second half of 2009 and Ranbaxy will retain 180-day exclusivity....
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/Patent Docs Blog/ July 30, 2007 -- The Federal Circuit addressed the contours of federal court declaratory judgment jurisdiction in light of the recent U.S. Supreme Court holding in MedImmune,Inc. v. Genentech, Inc. in a decision last week in Benitec Australia, Ltd. v. Nucleonics, Inc. Although the Federal Circuit's application of the law was uneventful, it was the dissent, by Judge Dyk, that suggested another front may be opening in the Court's decade-long effort to facilitate invalidating patents improvidently granted or to hold unenforceable patents obtained through inequitable conduct....
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MORRISTOWN, N.J., July 31, 2007 /PRNewswire/ -- Actavis Group, the international generic pharmaceuticals company, announced that it has launched Griseofulvin Oral Suspension in the United States. Distribution of the product will commence immediately....
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MADISON, N.J., July 31, 2007 /PRNewswire-FirstCall/ -- Wyeth, and its business partner Nycomed, announced today that the United States District Court for the District of New Jersey has taken the matter of Wyeth and Nycomed's motion for a preliminary injunction against Teva Pharmaceuticals USA, Inc. and Sun Pharmaceuticals Inc. in regard to a potential launch of a generic version of Protonix(R) (pantoprazole sodium) under advisement....
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TORONTO, July 31 /PRNewswire/ - Canadian prices for generic prescription drugs in 2006 were on average more than double American prices for identical drugs, according to a new study from independent research organization The Fraser Institute....
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/Patent Docs/ July 31, 2007 -- The Federal Circuit decided the Integra Lifesciences I, Ltd. v. Merck KGaA case last week on remand from the Supreme Court, which had (in)famously overturned the CAFC last year. In its earlier decision, the Federal Circuit had affirmed the District Court's finding that Merck's activities did not fall within the ambit of 35 U.S.C. § 271(e)(1)'s infringement exemption for activities "reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products,"...
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/Orange Book Blog/ July 31, 2007 -- Integra Lifesciences v. Merck KGaA, No. 2002-1052 (Fed. Cir. 2007) Last Friday, the Court of Appeals for the Federal Circuit decided Integra v. Merck, on remand from the Supreme Court. Click here for the opinion. The case has important implications for owners of "research tools" patents....
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