Generics Industry News Search
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May 2011 News Archive |
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An Abbott Laboratories unit accused generic drugmaker Teva pharmaceuticals USA in a lawsuit of patent infringement with plans to market a copy of Abbott's AndroGel testosterone preparation...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., has launched an authorized generic version of Concerta (methylphenidate hydrochloride extended-release tablets) as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI). Watson began shipping the product today. Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies...
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Teva Pharmaceutical Industries Ltd. and Cephalon, Inc. today announced that their Boards of Directors have unanimously approved a definitive agreement under which Teva will acquire all of the outstanding shares of Cephalon for $81.50 per share in cash, or a total enterprise value of approximately $6.8 billion. The transaction is not conditioned on financing and is expected to be completed in the third quarter of 2011...
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Watson Pharmaceuticals, Inc., today announced the U.S. commercial launch of Generess Fe 0.8 mg/25 mcg, a new low-dose oral contraceptive option that's highly effective at preventing pregnancy and proven to provide users with short, lighter, predictable periods...
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Teva Pharmaceutical Industries, the world's largest generic drug maker, will buy US biopharma firm Cephalon in a $6.8 billion deal, the companies said in a joint statement Monday....
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The leading Japanese financial newspaper "Nikkei" reports that Teva Pharmaceutical Industries Ltd. is close to acquiring the country's third largest generic drugmaker Taiyo Pharmaceuticals Industry Co. Ltd. for 40 billion, which is about $490 million...
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Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Limited, announce they have been granted final approval by the United States Food and Drug Administration for their Abbreviated New Drug Application for fluticasone propionate 0.05% lotion, Glenmark's generic version of Nycomed US ("Nycomed") Cutivate lotion...
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Lost in all the hubbub over the America Invents Act, Congress is considering another pair of bills that could have an equally deleterious effect on enforcing valuable patents...
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Mylan Inc.'s lawsuit seeking to force the U.S. Food and Drug Administration to act on Ranbaxy Laboratories Ltd.'s application to sell a generic version of Lipitor was dismissed by a federal judge in Washington...
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Actelion today commented on the verdict issued in regard to Asahi Kasei Pharma Corp. v. Actelion Ltd. et al. in which the jury awarded Asahi Kasei Pharma up to USD 547 million in compensatory damages...
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Axcan Intermediate Holdings Inc. announces that, as of today, it is changing its name to Aptalis Pharma...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its New Drug Application for DOCEFREZ (docetaxel) for Injection, 20 mg/vial and 80 mg/vial...
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On 12th November 2010 the Seoul Central District Court ruled in favour of a pharmaceutical company in a patent infringement case against a generic drug company, awarding approximately US$300,000 in damages...
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Sandoz today announced the US Food and Drug Administration approval and US launch of its new oral contraceptive brand Loryna, a generic equivalent of YAZ...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Oxycodone and Aspirin Tablets USP, 4.8355 mg/325 mg, based on an agreement with licensing partner Coastal Pharmaceuticals...
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Actavis launched Olanzapine tablets in Spain, Bulgaria, Slovakia and Hungary immediately after the patents expired on 24 April...
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Pfizer Inc. announced that Revatio (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension...
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The Supreme Court will hear a Canadian drug maker's challenge of the Viagra patent held by pharmaceutical giant Pfizer...
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Merck & Co. is close to settling patent lawsuits against Teva Pharmaceutical Industries Ltd. over a generic version of the cholesterol drug Vytorin, according to a federal court document...
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Impax Laboratories, Inc. today confirms that Alza Corporation has filed suit for patent infringement against Impax in the United States District Court for the District of Delaware in connection with Concerta extended-release 18, 27 and 36 mg tablets...
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Glenmark Generics Limited has entered into a settlement and license agreement with Nycomed US to resolve the patent infringement lawsuit regarding Glenmark's Abbreviated New Drug Application for Fluticasone Propionate 0.05% Lotion, currently marketed by Nycomed US as CUTIVATE...
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The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications...
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Drugmakers seeking U.S. approval for the first lower cost copies of biologic medicines made from living cells should initially pay application fees similar to charges for brand name medicines, regulators said...
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Alkermes, Inc. and Elan Corporation, plc today announced the execution of a definitive agreement under which Alkermes will merge with Elan Drug Technologies, the profitable, world-class drug formulation and manufacturing business unit of Elan, in a cash and stock transaction currently valued at approximately $960 million...
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Forest Laboratories, Inc. announced that it received a subpoena from the Office of the U.S. Attorney for the District of Massachusetts dated April 20, 2011...
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Somaxon Pharmaceuticals Inc said it filed a lawsuit against Icelandic generic drugmaker Actavis, challenging its application to make a copycat version of Somaxon's insomnia drug, Silenor...
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Dr. Reddy's Laboratories Ltd. announced today the launch of Peg-grafeel - Dr. Reddy's brand of pegfilgrastim...
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Depomed, Inc. today announced that it has received a Paragraph IV certification notice from Sun Pharmaceutical Industries advising Depomed that Sun has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market a generic version of Glumetza (metformin hydrochloride extended release tablets), 500 mg and 1000 mg strengths...
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Perrigo Co. Tuesday said it agreed to settle all Hatch-Waxman litigation relating to fluticasone lotion brought by Nycomed US Inc. by taking a license under all relevant patents...
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Speaking at the Reuters Health Summit on Tuesday, Chief Executive George Scangos said Biogen, which makes the multiple sclerosis drugs Avonex and Tysabri, is too small to develop a generic biotech business by itself. But he is interested in joining forces with a partner who could sell and market the drugs worldwide...
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Allos Therapeutics, Inc. and Mundipharma International Corporation Limited today jointly announced that the companies have entered into a strategic collaboration agreement to co-develop Folotyn(R) (pralatrexate injection). Under the agreement, Allos retains full commercialization rights for Folotyn in the United States and Canada, with Mundipharma having exclusive rights to commercialize Folotyn in all other countries. ...
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The Federal Trade Commission's Bureau of Competition has notified Sanofi-Aventis U.S. LLC, Watson Pharmaceuticals, Inc., and Synthon Holding B.V., that it believes the companies violated federal law by failing to inform antitrust authorities about drug patent agreements involving Sanofi's insomnia drug Ambien CR...
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In the quid pro quo of the free trade agreement (FTA) currently being negotiated with the European Union (EU), India could end up giving in to a provision which could hamper its exports of pharmaceuticals...
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Takeda Pharmaceutical Co., Asia's largest drugmaker, approached closely held Swiss competitor Nycomed about a possible takeover, said three people with knowledge of the situation...
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Takeda Pharmaceutical Co., Asia's largest drugmaker, fell the most in six weeks in Tokyo trading after three people familiar with the situation said the company approached Swiss competitor Nycomed about a takeover...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Risperidone Orally Disintegrating Tablets, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the generic version of Ortho-McNeil's Risperdal M-Tab, a treatment for schizophrenia...
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Teva Pharmaceutical Industries Ltd., Mylan Inc. and Anchen Pharmaceuticals Inc. won a judge's ruling over their planned generic version of the muscle-relaxant Amrix...
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About Court Report: Each week we will report briefly on recently filed biotech and pharma cases...
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Teva Pharmaceutical Industries Ltd. announced today that it has signed a definitive agreement to acquire 57% of the shares in privately-held Taiyo Pharmaceutical Industry Co. Ltd. for $460 million in cash paid to private shareholders...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Bromfenac Ophthalmic Solution, 0.09% (Twice Daily Administration), based on a development and supply agreement with Coastal Pharmaceuticals...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Pharma, Inc., has launched an authorized generic version of AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules) 15 mg and 30 mg, as part of an agreement with Anesta AG, a subsidiary of Cephalon, Inc...
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Having a healthy sex life will soon be more affordable for men with erectile dysfunction living in New Zealand. Pfizer, the drug company that makes Viagra (sildenafil citrate) will release a generic version of Viagra in New Zealand called Avigra when Viagra's patent for New Zealand expires in June...
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Amylin Pharmaceuticals, Inc. today announced that it has filed a lawsuit against Eli Lilly and Company in the United States District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide...
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Perrigo Co. says it has received approval from the U.S. Food and Drug Administration to market an over-the-counter, generic version of indigestion and heartburn-reliever Zantac 150...
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Breckenridge Pharmaceutical, Inc. announced that Breckenridge and Synthon Pharmaceuticals, Inc. have reached an agreement with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America resolving patent litigation related to Pioglitazone Hydrochloride...
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Merck, known as MSD outside the United States and Canada, announced today that it is has completed its acquisition of Inspire Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing ophthalmic products, for $5.00 per share in cash...
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Breckenridge Pharmaceutical, Inc. announced that Breckenridge and SynthonPharmaceuticals, Inc. have reached an agreement with Takeda Pharmaceutical Company Limited and TakedaPharmaceuticals North America, resolving patent litigation related to Pioglitazone Hydrochloride 15 mg, 30 mgand 45 mg tablets, a generic equivalent version of Actos...
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Mylan Inc., a U.S. maker of generic medicines, was ordered by a Paris court to pay French drugmaker Ipsen SA 17 million euros for presenting a pill to pharmacists as a substitute for an Ipsen product...
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The U.S. Supreme Court refused to consider Eli Lilly & Co. bid to re-establish the drugmaker's exclusive right to sell the cancer medicine Gemzar...
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Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary Aurobindo Pharma Australia Pty Ltd has received approvals from Therapeutic Goods Administration, Government of Australia for the registration of Risperidone Tablets 0.5mg, 1mg, 2mg, 3mg, 4mg and Oral Solution 1mg/1ml and Alendronate Tablets 70mg...
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Perrigo Company and its partner Synthon Pharmaceuticals, Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB's Xyzal Oral Solution...
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Silenor, the new sleeping pill made by Somaxon Pharmaceuticals in San Diego, is facing a threat of competition from yet another generic drug maker, the company said...
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Takeda Pharmaceutical Company Limited and Nycomed A/S jointly announced today that Takeda has reached an agreement with the shareholders of Nycomed in which Takeda will acquire the Zurich-headquartered company for 9.6 billion Euro on a cash-free, debt-free basis...
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Shire plc , the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has received a Paragraph IV Notice Letter from Sandoz Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE...
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Today, the United States District Court for the District of Delaware granted a motion filed by plaintiffs Cephalon Inc. and Eurand Inc., for a temporary restraining order enjoining Mylan Pharmaceuticals Inc., and Mylan Inc., from manufacturing, using, offering to sell or selling its cyclobenzaprine hydrochloride extended-release capsules, a generic version of Cephalon's branded product AMRIX...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Divalproex Sodium Capsules, 125 mg, the generics version of Abbott's Depakote Sprinkle Capsules, a treatment for certain types of seizures...
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Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Nitrofurantoin Oral Suspension in the 25 mg/5 ml strength effective May 13, 2011...
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Aurobindo Pharma got final approval from the US Food & Drug Administration to manufacture and market generic drug, Piperacillin and Tazobactam injection of varying strength packed in single use vials...
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Novartis announced today, that two affiliates of its Alcon Division, Alcon Laboratories, Inc. and Alcon Research, Ltd. have prevailed in a US patent infringement lawsuit filed along with Kyowa Hakko Kirin Co. Ltd. against Apotex, Inc. and Apotex Corp. in the US District Court for the Southern District of Indiana...
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After months of anxious waiting for the patent bar, the U.S. Court of Appeals for the Federal Circuit finally handed down its en banc ruling on inequitable conduct standards in Therasense Inc. v. Becton, Dickinson & Co. on Wednesday...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Oxycodone Hydrochloride (HCI) Tablets USP, 5 mg, 15 mg and 30 mg, based on a development and supply agreement with Coastal Pharmaceuticals...
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US Senate Finance Committee Chairman Max Baucus and senior Committee Member Chuck Grassley have sent a letter and a new Committee Report to the Food and Drug Administration detailing the financial relationship between the French pharmaceutical company Sanofi...
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InSite Vision Incorporated today announced that it will join Merck, known as MSD outside the United States and Canada, and Pfizer Inc. in filing a patent infringement lawsuit against Sandoz Inc...
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Intellipharmaceutics International Inc., today announced the following with regard to its generic drug commercialization activities...
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Pharmascience, the largest generic pharmaceutical company in Quebec, is pleased to announce the acquisition of Aegera Therapeutics Inc., a Montreal-based clinical-stage biotechnology company focused on developing targeted therapeutics to address thus far unmet major medical needs, primarily in oncology...
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Mylan Inc. today announced that it plans to rebrand its Hyderabad, India-based subsidiary Matrix Laboratories Limited as Mylan...
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Somaxon Pharmaceuticals Inc. disclosed it filed a patent-infringement lawsuit against Par Pharmaceutical Inc.following Par's request for approval to market generic versions of sleep aid Silenor in the U.S...
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Watson Pharmaceuticals Inc. recently announced that it has acquired Greece-based generic company, Specifar Pharmaceuticals SA, for Euro 400 million in cash...
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Somaxon Pharmaceuticals Inc. hit Par Pharmaceutical Cos. Inc. with a patent infringement suit in Delaware on Thursday, seeking to prevent the release of the generic drug maker's version of Somaxon's prescription insomnia medication Silenor
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The European Commission has recently launched an official investigation into a settlement agreement made between the US company Cephalon, and the Israeli generic medicine manufacturer, Teva
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Teva Pharmaceutical Industries Ltd. has obtained US Food and Drug Administration (FDA) approval for its generic version of Combivir tablets, an HIV treatment made by ViiV Healthcare Company...
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