Generics Industry News Search
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September 2010 News Archive |
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Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application for naltrexone hydrochloride 50 mg tablets from Mikah Pharma LLC....
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Actavis has received approval from the United States Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of ADHD (attention deficit / hyperactivity disorder)....
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GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for Arimidex(R) (Anastrozole), AstraZeneca's blockbuster drug for the treatment of breast cancer. The article analyses the surrounding patent landscape, highlighting the need for comprehensive, up-to-date information in the development of launch strategies that minimise the cost of litigation and understanding the barriers to launch as to receive the benefits of your generic product being first to market.
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AVESTHAGEN, a leading life science company pioneering the convergence between Food, Pharma and Population Genetics, today announced that the company has been granted a patent from Indian patent office for its robust process of production of Etanercept biosimilar....
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Pfizer has filed a patent infringement lawsuit against Mylan over its plans to market a generic version of Chantix, the popular smoking cessation drug that has come under fire for side effects linked to suicidal and violent behavior....
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Aurobindo Pharma is pleased to announce that it has entered into licensing and supply agreements with AstraZeneca, one of the world's leading biopharmaceutical businesses, to supply several solid dosage and sterile products for Emerging Markets....
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About 4 weeks ago The Public Patent Foundation (PUBPAT) announced that it had formally asked the United States Patent and Trademark Office to reexamine eight patents held by Abbott Laboratories relating to the HIV/AIDS drug ritonavir, which is marketed by the Chicago, Illinois pharmaceutical giant under the name brand Norvir....
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Sun Pharmaceutical Industries Ltd. today announced that the Supreme Court of Israel has unanimously dismissed the appeal by Taro Pharmaceutical Industries Ltd. of the previous ruling by the Tel-Aviv District Court holding that the Israeli special tender offer rules do not apply to the...
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Actavis Group today announced that it plans to enter into the field of biosimilars...
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Mylan Inc. today announced it has completed the acquisition of Bioniche Pharma Holdings Limited sooner than anticipated. Bioniche Pharma, an injectable pharmaceutical company, is providing Mylan with immediate entry into the North American injectables market and a platform for the commercialization of future biosimilar product offerings....
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Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin....
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A U.S. Appeals Court on Tuesday declined to consider a deeper legal review of patent settlements by drug companies that pay rivals to delay production of generic drugs, setting the stage for the Supreme Court or Congress to address the matter....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution...
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Abbott has completed its acquisition of Piramal's Healthcare Solutions business, propelling it to market leadership in the Indian pharmaceutical market and further accelerating the company's growth in emerging markets...
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Pharmaceutical company Bayer AG said Wednesday it will continue to pursue litigation against Watson Pharmaceuticals...
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Perrigo Company announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%...
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Pfizer appealed from a decision of the Federal Court declaring Pfizer's Canadian Patent No. 1,321,393 ( '393 Patent) relating to the medicine amlodipine besylate (NORVASC) invalid for obviousness...
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Biologic drug products ("biologics") are drugs created by living organisms and biological processes...
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Allergan Inc. has filed a patent-infringement lawsuit in federal court against Apotex Inc. in an attempt to stop Apotex from selling a generic version of the eyelash-enhancing drug Latisse before patent protection for the drug expires....
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This was an application brought by AstraZeneca under the provisions of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for...
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Aurobindo Pharma Limited is pleased to announce that the company has received final approvals from the US Food & Drug Administration for 3 ANDAs namely, Ampicillin & Sulbactam for Injection 1.5g and 3.0g (Infusion bottles), Ampicillin & Sulbactam for Injection 1.5g and 3.g (single-use vials) and Ampicillin & Sulbactam for Injection 15g USP (Pharmacy Bulk Pack)...
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The 2nd Circuit Court of Appeals ealier this week refused to reconsider its earlier decision to dismiss a lawsuit accusing Bayer AG of paying rivals to stay out of the generic Cipro market...
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With regulations covering biosimilar medicines falling into place around the world, there is a need to reach global agreement on criteria and guidelines for such products, say European generics industry leaders....
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Daiichi Sankyo Company, Limited announced that the United States Court of Appeals for the Federal Circuit has affirmed the U.S. District Court decision in patent litigation against Mylan, upholding the validity of the Daiichi Sankyo U.S. patent covering Benicar, Benicar HCT, and AZOR....
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Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle this week in a U.S. District Court....
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The emerging generic markets of the world are likely to outshine the US in the coming years but the fact remains that the US generic market is one of its kind...
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Santarus Inc.has struck a licensing deal with Pharming Group NV and acquired Covella Pharmaceuticals Inc., expanding the company's product pipeline...
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As health ministers get set to meet on Monday, generic drug companies are warning that a growing push by provinces to lower the price of generic medicines could seriously backfire, making it unfeasible for manufacturers to produce some no-name drugs or mount expensive court challenges of brand-name patents...
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It was not a question of whether ViroPharma Incorporated would sue FDA in connection with the approval of ANDAs for generic versions of the company's antibiotic drug of last resort, VANCOCIN (vancomycin HCl) Capsules, but when....
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India's Intas Pharmaceuticals Ltd. has signed an agreement to license and supply generic drugs to AstraZeneca PLC for sale in emerging markets, highlighting the trend of pharma majors looking at low-cost supplies to offset the pressure due to products coming out of patents...
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IGI Laboratories, Inc., a New Jersey based formulation and manufacturing company, today announced that it has submitted its first abbreviated new drug application to the US FDA...
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Elite Pharmaceuticals, Inc. announced today the signing of a license agreement and a manufacturing and supply agreement with Precision Dose, Inc. which has a wholly owned subsidiary...
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The generic-drug company Actavis is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings from Bioton, a Polish biotechnology company...
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A new study published on Tuesday has established that Indian generic manufacturers supplied more than 80% of donor-funded AIDS medicines to developing countries in the last seven years, confirming India's status as the pharmacy of the Third World...
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Do you have an ANDA prior approval supplement pending at FDA? How long has it been pending - 6 months? One year? 18 months? Well it might still some time until there is any action on it...
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Marketing approvals for generic drugs may soon get delinked from their patent status, a long-standing demand of India's pharmaceutical industry that depends heavily on the sale of generic drugs...
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The European Medicines Agency has been formally notified by Swiss drug major Novartis of its decision to withdraw its application for a centralized marketing authorization for Rasival, a combination of aliskiren (a direct renin inhibitor sold as Rasilez in Europe and Tekturna in the USA) and valsartan (the active ingredient of its blockbuster antihypertensive Diovan which loses patent protection in 2012 but generated sales of $1.55 billion in second-quarter 2010), 150/160mg and 300/320mg film-coated tablets...
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Mylan Inc. today obtained a temporary restraining order from the U.S. District Court for the District of New Jersey that prohibits Apotex from "using, offering to sell, selling or shipping or otherwise launching ... or importing" all three strengths of a generic version of GlaxoSmithKline's Paxil CR...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf(R) Capsules, a treatment to prevent rejection in people who have received certain organ transplants...
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Ranbaxy Laboratories Ltd., India's biggest drugmaker by sales, rose to the highest level in more than two years in Mumbai after winning exclusive rights to sell a generic version of Eisai Co.'s Alzheimer's treatment....
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Teva Pharmaceutical Industries Ltd. announced today it has filed a complaint in the U.S. District Court for the Southern District of New York against Mylan asserting infringement of four patents related to the characterization of COPAXONE (glatiramer acetate injection)....
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The European Medicines Agency today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim. These medicines will stop being available in Europe within the next few months...
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Perrigo Company announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner....
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Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced that it has received Australian Therapeutic Goods Administration approval for its biosimilar filgrastim product, Nivestim(TM)...
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Eli Lilly brought suit against Apotex alleging that it infringed eight (8) process patents...
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The Federal Court granted a prohibition order, holding that Teva's allegation that the patent at issue was obvious was not justified...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted a tentative approval for its Abbreviated New Drug Application to market a generic version of Sanofi Aventis's Rilutek tablets 50 mg....
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Endo Pharmaceuticals announced today that it has entered into a definitive agreement to acquire Qualitest Pharmaceuticals, a leading, privately-held generics company in the U.S., for approximately $1.2 billion in cash...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application to market a generic version of IPR Pharmaceutical's Crestor tablets 5mg, 10 mg, 20 mg, 40 mg....
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Indian drugmakers, after building their fortunes from selling generic medicines, are now looking at copying biotech drugs to drive further growth...
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Republican senators are vowing to block a measure that would put limits on patent agreements between generic and brand-name drug companies, a practice that critics call pay-for-delay deals...
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Drug firm Lupin today said it has acquired a majority stake in Australia's Generic Health for an undisclosed amount...
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Two years ago, Pfizer reached a deal that generic Lipitor, the best-selling drug in the U.S., would launch on Nov. 30, 2011...
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Dr Reddy's Laboratories expects North American sales to more than double to about USD 1 billion by fiscal 2013 and is planning to expand its presence in emerging markets like Russia and India, a company official said...
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Rising share in the US generics market and off-patent opportunities should benefit top Indian drug makers...
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Daiichi Sankyo Espha Begins Operations in Japan to Sell Generics and Long-listed, Off-patent Pharmaceuticals with Proven Market Presence...
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