Generics Industry News Search
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October 2007 News Archive |
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CHICAGO--(BUSINESS WIRE)--Oct 1, 2007 - Welsh & Katz client, Apotex, Inc., received a major victory in its ongoing legal battle with Pfizer today when the U.S. Supreme Court turned down Pfizer's request for a writ of certiorari. The Court's decision means the ruling in Pfizer, Inc. v. Apotex, Inc. 2006-1261 on the issue of obviousness continues to stand as a precedent to be used in future pharmaceutical cases....
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ESPOO, Finland, Oct. 1, 2007-Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed with the U.S. Food and Drug Administration (FDA) by a generic drug company seeking authorisation to produce and market generic versions of Stalevo® tablets (25/100/200 and 37.5/150/200 mg strengths of carbidopa/levodopa/entacapone) in the United States....
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/Orange Book Blog/ October 01, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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PITTSBURGH, Oct. 2 /PRNewswire-FirstCall/ -- Mylan announced today that it has completed its acquisition of Merck KGaA's generics business ("Merck Generics") to become one of the largest quality generics and specialty pharmaceuticals companies in the world. Mylan and Merck KGaA initially announced the signing of a definitive agreement under which Mylan would acquire Merck Generics for EUR 4.9 billion ($6.7 billion) in an all-cash transaction on May 12, 2007....
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PRINCETON, N.J., Oct. 2 /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 (U.S. FDA) to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets....
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PITTSBURGH, Oct. 2 /PRNewswire-FirstCall/ -- Mylan announced today that it has completed its acquisition of Merck KGaA's generics business ("Merck Generics") to become one of the largest quality generics and specialty pharmaceuticals companies in the world. Mylan and Merck KGaA initially announced the signing of a definitive agreement under which Mylan would acquire Merck Generics for EUR 4.9 billion ($6.7 billion) in an all-cash transaction on May 12, 2007....
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CHADDS FORD, PA., and DANBURY, CT, Oct 03, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP) and Penwest Pharmaceuticals Co. (NASDAQ: PPCO) announced today that they have received a notice from IMPAX Laboratories, Inc. advising of the filing by IMPAX of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for oxymorphone hydrochloride extended-release tablets CII....
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NORTH WALES, Pennsylvania, Oct. 3, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Quinapril Tablets USP. This product is AB rated and bioequivalent to Accupril Tablets. Quinapril Tablets are available in 5 mg, 10 mg, 20 mg, and 40 mg strengths, in bottle sizes of 90 and 500.
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CORONA, Calif., October 03, 2007 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of FEMCON(R) Fe tablets prior to the expiration of patents owned by Warner Chilcott Company, Inc., a subsidiary of Warner Chilcott Limited....
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WALTHAM, Mass., October 03, 2007 /PRNewswire/ -- Decision Resources, Inc., one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that U.S. payers expect to incorporate biogeneric agents into their formularies quite rapidly. According to the new special report entitled Biogenerics 2007-2016: Physician and Payer Acceptance Fuels Brand Erosion, approximately 60 percent of pharmacy directors expect to reimburse biogenerics within a drug's first six months on the market and nearly 100 percent of surveyed payers will include these agents on their formularies within the first year....
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/Orange Book Blog/ October 03, 2007 -- American Conference Institute will hold its eighth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 24-25 in New York. According to ACI, this is the "one and only event that has consistently allowed brand name and generic drug makers to benchmark their companies' current strategies and tactics against competitors in both camps."...
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/Pharmalot Blog/ October 3rd, 2007 -- Let us count the ways. The fight beween the drugmaker and New Delhi over its Gleevec patent was a cause celebre this year. But an analysis in IP Law & Business points out that Novartis flubbed it. And it’s a lesson for others…
Click here to read full article (www.pharmalot.com)...
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WASHINGTON, October 04, 2007 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.
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ARLINGTON, Va., October 04, 2007 /PRNewswire-USNewswire/ -- Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger today released the following statement regarding the Food and Drug Administration's update on their efforts to improve the generic drug approval process:...
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HAYWARD, Calif.--(BUSINESS WIRE)--Oct 4, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today confirmed reports that it has provided notice to Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. that it has submitted an Abbreviated New Drug Application (ANDA) for oxymorphone hydrochloride extended-release tablets CII, generic of Opana(R) ER, to the U.S. Food and Drug Administration (FDA). IMPAX's ANDA, as amended, contains a Paragraph IV certification stating that the Company believes its product does not infringe US Patent No. 7,276,250, or that the patent is invalid or unenforceable. ...
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PITTSBURGH, Oct. 4 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into an agreement to settle pending litigation with UCB Societe Anonyme and UCB Pharma Inc. (collectively, UCB) relating to Levetiracetam Tablets, 250mg, 500mg and 750mg, the generic version of UCB's Keppra(R).
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GURGAON, HARYANA, India, Oct. 4, 2007 - Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets....
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/IP ThinkTank Blog/ October 4, 2007 -- There's a common strategic issue for generic pharmaceutical manufacturers as to whether they should obtain a win in court before launching their product. The risks are (a) an injunction and (b) accumulated damages if the generic decides to wait and see what the innovator company will do. The issue is not unique to the pharmaceutical industry, but the pressure is a little more acute because of the absolute monopoly in the product enjoyed by the innovator company just prior to the first generic launch....
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WASHINGTON, October 05, 2007 /PRNewswire-USNewswire/ -- The Coalition for a Competitive Pharmaceutical Market (CCPM) issued the following statement today on the Food and Drug Administration's announcement regarding its "Generic Initiative for Value and Efficiency" (GIVE):...
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SCHAUMBURG, Ill.--(BUSINESS WIRE)--Oct 5, 2007 - Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced the tentative approval from U.S. Food and Drug Administration (FDA) to market Irinotecan Hydrochloride Injection, 20 mg/mL, 2 mL, and 5 mL, the generic equivalent of Camptosar(R) Injection manufactured by Pfizer Inc. ...
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JERUSALEM--(BUSINESS WIRE)--Oct 5, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of GlaxoSmithKline's antiviral product Valtrex(R) (Valacyclovir Hydrochloride) Tablets. Final approval of this ANDA is anticipated in December 2009. ...
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NORTH WALES, Pa., October 5, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Famciclovir Tablets. This product is AB rated and bioequivalent to Famvir®* Tablets. Famciclovir Tablets are available in 125 mg, 250 mg, and 500 mg strengths, in bottle sizes of 30....
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DETROIT, October 05, 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 Cetirizine Hydrochloride Chewable Tablets, 5 mg and 10 mg (Cetirizine HCl Chewable). Final approval to market this product is anticipated subsequent to the expiry of patent protection on December 25, 2007....
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NORTH WALES, Pennsylvania, Oct. 5, 2007 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Carvedilol Tablets. This product is AB rated and bioequivalent to Coreg®* Tablets. Carvedilol Tablets are available in 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg strengths, in bottle sizes of 100....
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/Patent Baristas Blog/ October 5th, 2007 -- The US Food and Drug Administration (FDA) today announced a new program aimed at speeding up the approval process for generic drugs. FDA predicts that the program, aptly called GIVE the Generic Initiative for Value and Efficiency, would give a gift to generic companies by helping the FDA approve generic drugs more quickly. ...
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/New Vision/ Kampala, 5 October 2007 -- A year ago it was a potato garden. Now the 15-acre plot is hosting a hi-tech pharmaceutical factory, the first of its kind in Africa. The factory, to be commissioned by President Yoweri Museveni on Monday, will produce the full triple therapy combination of antiretroviral (ARV) drugs, something that has not been done in Africa before. ... The new factory, located adjacent to Luzira Women's Prison, is a joint venture between QCI and the Indian pharmaceutical Cipla. It will produce Triomune...
Click here to read full article (allafrica.com)...
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/Inquirer/ 10/06/2007 MANILA, Philippines -- Can a nine-word sentence in the law make a difference in the lives of 88 million Filipinos? The House of Representatives’ committee version of the cheaper medicines bill has dropped a key provision in the Generics Act of 1988, which critics say has kept patients from availing themselves of lower-priced drugs. The statement -- “the brand name may be included if so desired” -- was deleted in the omnibus bill, ostensibly to revive the essence of the once-promising piece of legislation. Click here to read full article (newsinfo.inquirer.net)...
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/IPKat Blog/ 07 October 2007 -- Last week, Canada became the first country to notify the TRIPS Council of the World Trade Organization (WTO) under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration of the TRIPS Agreement and Public Health....
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JERUSALEM, Israel, October 8, 2007 - 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 its generic version of Procter and Gamble Actonel® (Risedronate Sodium) Tablets, 5 mg, 30 mg and 35 mg....
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ROCKVILLE, Md., Oct. 10, 2007-The U.S. Food and Drug Administration today approved the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. Generic oxcarbazepine is FDA-approved for use alone or in combination with other medications in the treatment of partial seizures in adults and children aged four years and above....
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MUMBAI, India, October 10, 2007-Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal®, oxcarbazepine tablets....
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COLUMBUS, Ohio, October 10, 2007 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Tablets, 150mg, 300mg and 600mg by the U.S. Food and Drug Administration. The product is available in bottles of 100 tablets and Unit Dose Blisters for immediate shipment to wholesalers and pharmacies nationwide....
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LA PLATA, Md., October 10, 2007 /PRNewswire-USNewswire/ -- Today Maryland community pharmacy owners held a press conference at County Drug urging U.S. House Majority Leader Steny Hoyer (D-Md.) to bring H.R. 3140 -- Saving Our Community Pharmacies Act of 2007 -- to the House floor for a vote. The Medicaid generic prescription drug pharmacy reimbursement will take effect in early 2008, and if left alone threatens community pharmacy's economic viability, as well as patient access to pharmacy services....
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PHILADELPHIA--(BUSINESS WIRE)--Oct 10, 2007 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, is pleased to comment on the recent Food and Drug Administration (FDA) announcement regarding Levothyroxine sodium. The FDA issued a public notice adopting the recommendation of an advisory group of endocrinologists tightening the label specifications for potency range to 95-105%....
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RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- 10/09/07 -- In the face of generics competition, drug companies spend tens of millions of dollars on strategies to retain revenue and market share, according to a new report released today by Cutting Edge Information. "Combating Generics 2008: Counter-Generics Strategy, Tactics and Execution" explores the different options open to branded pharmaceutical makers as drugs near the end of patent life.
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BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Oct 11, 2007 - Akorn, Inc. (NASDAQ: AKRX) today announced that it has signed an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals, a privately-held company located in Sunrise, Florida. The agreement is intended to develop an ANDA oral drug product for women's healthcare. The current market size is approximately $115 million, according to recent IMS sales data. Financial terms of the agreement were not disclosed....
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HAWTHORNE, N.Y.--(BUSINESS WIRE)--Oct 11, 2007 - Acorda Therapeutics, Inc. (NASDAQ: ACOR) announced today that it has filed a lawsuit against Apotex Corp. and Apotex Inc. in the United States District Court for the District of New Jersey asserting infringement of the Company's U.S. Patent No. 6,455,557 relating to multiparticulate tizanidine compositions, such as those sold by the Company as Zanaflex Capsules(TM)....
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WHITE PLAINS, N.Y. and DURHAM, N.C. — Oct. 12, 2007 — ConsumerLab.com reported today that its tests of a generic version of the popular antidepressant drug Wellbutrin showed differences between the generic and original that might explain recent consumer complaints about the generic product. In February, readers of The People's Pharmacy® syndicated newspaper column began reporting problems with this generic version of once-a-day Wellbutrin XL 300....
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WOODCLIFF LAKE, N.J., October 15, 2007 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced it has entered into a settlement agreement with Valeant Pharmaceuticals North America that resolves patent litigation related to Valeant's Diastat(R) products, thereby eliminating the inherent uncertainty and costs of litigation. The agreement reflects the terms previously agreed to in principle at a settlement conference in June 2007....
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WOODCLIFF LAKE, N.J., October 15, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its Barr Laboratories, Inc. subsidiary and Par Pharmaceutical Companies, Inc. have entered into a settlement agreement regarding their joint patent challenge with Valeant Pharmaceuticals North America related to Valeant's DIASTAT(R) diazepam rectal gel products....
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/Patent Docs Blog/ October 15, 2007 -- In an opinion authored by Chief Judge Michel and issued late last week, the CAFC reversed the United States District Court for the Northern District of Illinois, finding Apotex not to have violated an injunction prohibiting it from manufacturing, using, selling, offering for sale, or importing into the United States generic divalproex sodium until the expiration of U.S. Patent Nos. 4,988,731 and 5,212,326. ...
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/Orange Book Blog/ October 15, 2007 -- Links to recent pharma articles of interest selected by Aaron Barkoff of the Orange Book Blog...
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SCHAUMBURG, Ill.-- (BUSINESS WIRE) Oct 16, 2007 -- Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), today announced two approvals from U.S. Food and Drug Administration (FDA) to market the liquid and lyophilized versions of Fludarabine phosphate. The lyophilized version of fludarabine, which is the generic equivalent of Fludara® (fludarabine phosphate) for injection distributed by Bayer HealthCare Pharmaceuticals Inc., will be packaged in 50 mg/2mL single-dose vials....
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MUMBAI, India, October 16, 2007 - Sun Pharmaceutical Industries Ltd. announced receipt of a Covenant Not to Sue from Wyeth over Sun Pharma’s Abbreviated New Drug Application (ANDA) for generic venlafaxine extended release tablets with multiple para IV certifications....
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SCHAUMBURG, Ill.--(BUSINESS WIRE)--Oct 17, 2007 - Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ: ABBI), today announced approval from U.S. Food and Drug Administration (FDA) to market Epirubicin hydrochloride injection in four dosage forms. Two of the dosage forms (2mg/mL 5mL and 2mg/mL 75mL) are unique codes and are not currently available on the market....
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DETROIT, October 17, 2007 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today that it has launched a generic version of Trileptal(R), Oxcarbazepine Tablets (oxcarbazepine), on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). ...
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/The Economic Times/ 17 Oct, 2007 MUMBAI: Dr Reddy's Laboratories is finalising plans to enter the Japanese market, the world's second largest pharmaceutical market. The Hyderabad-based company is looking for a partner to launch its products in Japan by next fiscal year. "We are talking to a few pharma companies but have not finalised any agreement yet," said vice-chairman and chief executive officer G V Prasad, in a recent interview with ET. "The Japanese market represents a great opportunity for generic pharma companies. However, it is also a very complicated market," he added. Click here to read full article (economictimes.indiatimes.com) ...
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HAYWARD, Calif.--(BUSINESS WIRE)--Oct 18, 2007 - IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Effexor XR(R) (venlafaxine HCl) 37.5mg, 75mg and 150mg extended release capsules....
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/IP Thinktank Blog/ October 18, 2007 -- I have just found out from the Generic Pharmaceuticals and IP blog that Teva has now sued 16 companies in relation to its Carvedilol process patents. The 16 defendants are: Zentiva; Mylan; Taro Pharmaceuticals; Lupin; Moehs Iberica; Urquima; Orchid; Wanbury;Z hejiang Huahai; USV Ltd.; Cadila; Ranbaxy; Dr. Reddy's Laboratories; Watson; Zambon andApotex. ...
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/The IN VIVO blog/ October 18, 2007 -- Biosimilars may have won a regulatory pathway in Europe, but they’re having a tough time getting to patients. Last week Spain became the second of Europe’s big five markets, after France, to announce this year that biologic drugs cannot automatically be substituted. Italy is expected to announce a similar decision before year-end. Click here to read full article (invivoblog.blogspot.com)...
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18 October 2007 -- AstraZeneca today announced that the European Patent Office (EPO) Technical Board of Appeal has made a final ruling that the European Combination patent for Symbicort® (formoterol and budesonide) (EPB0613371) has been revoked, following an appeal from a group of generic manufacturers
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October 19, 2007 -- Yesterday STADA received, as expected, in the ongoing EU-wide approval process for Erythropoietin-zeta (Epo-zeta), a “positive opinion” from the responsible EU approval agency EMEA. The “positive opinion” includes, as requested, the indications nephrology (dialysis) and oncology. Thus, an EU-wide approval of Epo-zeta for these indications can still be expected in the current year.
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/Patent Docs Blog/ October 21, 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: Cobalt v. Bayer (Acarbose); Sanofi-Aventis v. Aurobindo & Sun (Alfuzosine)...
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William (Bill) Haddad - Dubai, October 21, 2007 -- Perhaps the title of my discussion this morning should be called “The Skunk at the Garden Party” because it concerns the mounting barriers to effective competition. I am not sure our industry takes full note of the effectiveness or consequences of these barriers on our markets, our profits and our mission to provide safe, effective and affordable medicines for use worldwide....
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TOKYO, BRISTOL, Tenn., and JERUSALEM, October 22, 2007 /PRNewswire/ -- Astellas Pharma Inc. , King Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. today announced settlement agreements with Teva's subsidiaries regarding their submission of an abbreviated new drug application ("ANDA") for a generic version of Adenoscan(R) (adenosine injection), a pharmacologic stress agent....
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TORONTO, October 22, 2007 /PRNewswire/ - IntelliPharmaCeutics Ltd. (the "Company") today announced the following with regard to its generic drug commercialization activities. ... The application seeks the FDA's approval to commercialize generic versions of each of 4 strengths of a branded drug called FOCALIN XR(R)....
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Gurgaon, Haryana, India - October 22, 2007 -Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval in Canada to manufacture and market Ran®-Lisinopril 5, 10 and 20 mg oral tablets from Health Canada, Therapeutic Products Directorate (TPD). Total brand market for Lisinopril 5, 10, and 20 mg oral tablets in Canada is CAD $46 mil. (IMS-MAT: August 2007).
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WALTHAM, Mass., October 23, 2007 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the patent expiries of Pfizer's Lipitor (also known as Tahor, Sortis, Torvast and Cardyl), Sanofi-Aventis/Bristol-Myers Squibb's Plavix/Iscover, Merck's Zocor and Banyu's Lipovas will cause the post- myocardial infarction drug market to decline nearly $1 billion by 2016....
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NEW YORK--(BUSINESS WIRE)--Oct 23, 2007 - Pfizer Inc said today that the Court of Appeal of Barcelona has upheld the company's enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, reversing the lower court decision. The calcium salt patent expires in July 2010.
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NUTLEY, N.J.--(BUSINESS WIRE)--Oct 23, 2007 - Roche announced today that a jury in the U.S. District Court in Massachusetts found in favor of Amgen in the patent infringement dispute relating to the Roche erythropoiesis-stimulating agent, MIRCERA(R) . Roche is currently evaluating its legal options, including the possibility of an appeal....
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PATERSON, N.J., October 23, 2007 /PRNewswire/ -- Amneal Pharmaceuticals, a New Jersey-based developer, manufacturer and distributor of generic pharmaceuticals and Indoco Remedies, an India-based API and finished dosages development and manufacturing company announce the finalization of a joint venture partnership to develop, manufacture, market and distribute several products for the United States market....
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THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Oct 23, 2007 - Amgen (NASDAQ:AMGN) announced today that a jury in the U.S. Federal District Court in Boston ruled that Roche's pegylated-erythropoietin (peg-EPO) product MIRCERA infringes 11 Amgen EPO patent claims....
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PITTSBURGH, Oct. 23 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that it and its subsidiary Mylan Pharmaceuticals Inc. have entered into a patent license and settlement agreement with GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GSK's Paxil CR®....
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DETROIT, Mich., Oct. 23 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., today announced that it ranked in the top 500 on Deloitte's 2007 Technology Fast 500, a ranking of the 500 fastest growing technology, media, telecommunications and life sciences companies in North America. ...
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Oct. 23 (Bloomberg) -- Mylan Pharmaceuticals Inc. was accused in a lawsuit by drugmaker Sciele Pharma Inc. of infringing a patent for Sular, a medicine used to treat high blood pressure. Sciele contends the generic-drug maker plans to market a copy of 40-milligram, extended-release tablets of Sular, which is protected by a 1990 patent... Click here to read full article (www.bloomberg.com)...
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/IP Thinktank Blog/ October 23, 2007 -- The recent study which I undertook on pharmaceutical lifecycle management yielded some interesting findings apart from decreasing periods of monopoly and earlier patent filings by non-innovators (both of which I have previously written about). ... One of the many other interesting observations was the way that the period of monopoly can be enhanced by strategic acquisition of third party intellectual property (in this context, read 'patents')....
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EXETER, NH, October 23, 2007 – Bentley Pharmaceuticals, Inc. (the “Company” or “Bentley”) (NYSE: BNT), today announced that its Board of Directors has completed a strategic review of the Company and unanimously approved a plan to separate its drug delivery business from Bentley in a transaction that will result in two independent and highly focused public companies. The Board of Directors also announced its intention to explore strategic alternatives with respect to its generics business....
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Mumbai, October 23, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Exelon®, rivastigmine tartrate capsules. These generic rivastigmine capsules are AB-rated equivalent of Novartis Exelon® Capsules...
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WALTHAM, Mass., October 24, 2007 /PRNewswire/ -- Decision Resources, Inc., one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that biogeneric TNF-alpha inhibitors for the treatment of rheumatoid arthritis will become the first $1 billion biogeneric class across the United States and Europe in 2014. U.S. biogeneric TNF-alpha inhibitors will experience high growth following their entry in 2012 before peaking in 2013 at nearly $800 million in the United States alone. ...
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Mumbai, 24 Oct,2007 -- Pharmaceutical and Biotechnology major Wockhardt Limited today announced the acquisition of Morton Grove Pharmaceuticals Inc., a leading liquid generic and speciality dermatology company in the US having a sales revenue of US$ 52 million....
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ST. LOUIS, October 25, 2007 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it has received approval from the U.S. Food and Drug Administration (FDA) on its application for the 100 mg and 200 mg strengths of Morphine ER Tablets (MS Contin(R) marketed by Purdue Pharma L.P.). This approval now allows ETHEX Corporation, KV's wholly-owned generic/non-branded subsidiary, to offer a full line of all strengths of this product....
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WOODCLIFF LAKE, N.J., October 25, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Alcon, Inc. in connection with Alcon's Patanol(R) (olopatadine hydrochloride ophthalmic solution) 0.1%....
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WOODCLIFF LAKE, N.J., October 26, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Warner Chilcott Company, Inc.'s Estrostep(R) Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) oral contraceptive product....
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/Patently-O Blog/ Oct 26, 2007 -- Par Pharmaceuticals v. Roxane Labs (Fed. Cir. 2007) (Nonprecedential)
Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS. After obtaining patent protection, Par sued Roxane for infringement....
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/Orange Book Blog/ October 28, 2007 -- Par Pharmaceuticals v. Roxane Labs, No. 2007-1093 (Fed. Cir. 2007) In the early 1990s, Bristol-Myers Squibb developed and patented Megace, a liquid pharmaceutical composition of megestrol acetate indicated for the treatment of anorexia, cachexia, or an unexplained weight loss. Par Pharmaceuticals sought to design around the claims of BMS's patent and introduce a generic version of Megace....
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/Patent Docs Blog/ October 28, 2007 -- Amgen's recombinant erythropoietin (EPO) franchise (Aranesp® and Epogen®, as well as Johnson & Johnson's Procrit®) survived another challenge last week, when a jury found that Hoffmann-LaRoche's pegylated EPO preparation (Micera®) infringed three Amgen patents: U.S. Patent Nos. 5,547,933 (the '933 patent), 5,441,868 (the '868 patent), and 5,618,698 (the '698 patent)....
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/Patent Docs Blog/ October 28, 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: Purdue v. Par (tramadol); Alcon v. Barr (olopatadine); Sciele v. Mylan (nisoldipine); Schering v. Dr Reddy's (desloratidine & pseudoephedrine); King v. Actavis (morphine), Sepracor v. Mylan (desloratidine)...
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FAJARDO, Puerto Rico and CORONA, Calif., October 29, 2007 /PRNewswire-FirstCall/ -- Warner Chilcott Company, Inc. and Watson Pharmaceuticals, Inc. announced today that under a supply agreement between Warner Chilcott and Watson Pharma, Inc., Watson has launched Tilia(TM) Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), the generic version of Warner Chilcott's oral contraceptive Estrostep(R) Fe....
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PRINCETON, N.J., October 29, 2007 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valsartan Tablets, 40 mg, 80 mg, 160 mg and 320 mg. Total annual market sales for Valsartan Tablets were $1.3 billion (IMS - MAT: June 2007)....
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EXETER, N.H.--(BUSINESS WIRE)--Oct 29, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company focused on advanced drug delivery technologies and generic pharmaceutical products, today announced five generic product approvals from the Spanish Ministry of Health and an approval for simvastatin from the Irish Medicines Board....
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NEW YORK--(BUSINESS WIRE)--Oct 29, 2007 - Pfizer Inc said today that the Federal Patent Court in Munich, Germany has revoked the company's patent covering atorvastatin calcium, the active ingredient in Lipitor. The patent at issue in the lawsuit (EP 409,281) expires in July 2010....
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WOODCLIFF LAKE, N.J., October 30, 2007 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex(R) (Pramipexole Dihydrochloride) Tablets, 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg....
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