Generics Industry News Search
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December 2008 News Archive |
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Mylan Inc. today confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules....
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Teva Pharmaceutical Industries Ltd turned itself into the world's biggest maker of generic medicines through a high-risk strategy of flouting drug patents. Its next target may be Eli Lilly's Evista, an osteoporosis treatment with more than $700 million a year in U.S. sales. ...
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Actavis today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market Bupropion Hydrochloride extended-release tablets (XL) 150mg. Distribution of the product has commenced. ...
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Alkermes, Inc. today announced that it has regained from Cephalon, Inc. full commercialization rights to VIVITROL(R) (naltrexone for extended-release injectable suspension) in the U.S. following a portfolio review by Cephalon. The collaboration between the two companies will terminate effective December 1, 2008. VIVITROL, the first and only long-acting injectable medication commercially available for the treatment of alcohol dependence, is also being developed by Alkermes as a potential treatment for opioid dependence. ...
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Mylan Inc. today announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis' Femara....
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Ratiopharm, the generic-drug maker owned by embattled German billionaire Adolf Merckle, said on Tuesday it failed to secure bulk procurement contracts in the latest tender by Germany's largest healthcare insurer....
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Drug companies made multiple patent applications for the same medicine and started litigation to prevent or block rivals from entering the market for generic drugs, according to evidence presented as part of a European Commission inquiry....
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Oscient Pharmaceuticals Corporation today announced that the Company and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Antara (fenofibrate) capsules, 130 and 43 mg doses. ...
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Ranbaxy Laboratories Limited (Ranbaxy) today announced that the Company has received import permission for marketing the US FDA approved product GLIADEL (polifeprosan 20 with carmustine implant) Wafer for the treatment of newly diagnosed high-grade malignant gliomas and recurrent glioblastoma multiforme. Ranbaxy has signed an exclusive licensing agreement with BioPro Pharmaceutical, Inc., (BioPro) USA to promote and market Gliadel Wafer in India. ...
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The Perrigo Company announced today that all Hatch-Waxman litigation relating to Desloratadine tablets (5 mg) has been settled with Perrigo taking a license under all relevant patents...
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Actavis has signed an exclusive distribution and packaging agreement for a number of generic products with Laboratoire Pharmaceutique Algerien (LPA), an Algerian owned and operated pharmaceutical company, headquartered in Algiers....
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Finnish drugmaker Orion has filed a patent infringement suit against Sun Pharma Global, which submitted an ANDA to market a generic version of Comtan in 200-mg tablets to treat Parkinson's disease. The suit against Sun Pharma, a subsidiary of India's Sun Pharmaceutical Industries based in the British Virgin Islands, was filed in the U.S. District Court for the District of New Jersey. Sun Pharma notified Orion and Novartis last month that it had filed an ANDA to market a generic version of Comtan (entacapone) before the drug's '194 patent expires Oct. 19, 2013.
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Aurobindo Pharma Limited is pleased to announce that the company has received tentative approvals from the US Food & Drug Administration (USFDA) for Perindopril Erbumine Tablets 2mg, 4mg, 8mg and Escitalopram Oxalate Oral solution 5mg (base) / 5ml.
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Ratiopharm, the generic-drug maker owned by embattled billionaire Adolf Merckle, has failed to win any contracts in the latest supply tender by Germany's largest healthcare insurer, several sources said on Monday...
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Orion Corporation filed a patent infringement lawsuit in the United States to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA, Inc. and Wockhardt Limited, who seek to market a generic version of Orion Corporation's proprietary drug, Stalevo...
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Unigene Laboratories, Inc. that Judge Robert P. Patterson, Jr. of the United States District Court for the Southern District of New York entered a preliminary injunction, consented to by defendants Apotex, Inc. and Apotex Corp., preliminarily enjoining them from engaging in the commercial manufacture, use, marketing, distribution, selling, transportation or importation of any Fortical generic equivalent product in the United States...
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Warner Chilcott Limited announced today that one of the Company's subsidiaries and Hospira, Inc. have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. advising that each such company has filed an Abbreviated New Drug Application for generic versions of Doryx 100 and 75 mg delayed-release tablets...
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Teva Pharmaceutical Industries Ltd. today announced that it has completed the drawdown of its combined $1.75 billion bridge loan facilities with Bank Hapoalim B.M. and Bank Leumi USA. The proceeds of the loans will be used towards funding Teva's previously announced acquisition of Barr Pharmaceuticals, Inc...
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Merck & Co will start a new unit to copy biotechnology medicines, becoming the first big U.S. maker of conventional drugs to leap into the $94 billion market for treatments based on living cells....
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Teva Pharmaceutical Industries Ltd. today announced that it has received notification from Allgemeinen Ortskrankenkassen (AOK), Germany's largest health insurance company, on the results of the most recent tender for finished dosage pharmaceutical products...
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Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Wockhardt Limited (Wockhardt) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market generic versions of Stalevo (specifically the 25/200/100; 37.5/200/150 and 50/200/200 mg strengths) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent....
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Swiss drug maker F Hoffman-La Roche Ltd won a partial victory in its legal battle against India's Cipla Ltd over anti-infection drug valganciclovir, with the Bombay high court ruling in favour of the Swiss company in a trademark infringement case....
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Two days after Merck & Co announced a major push into generic versions of biotechnology medicines, Eli Lilly and Co on Thursday signaled similar aspirations "down the road."...
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Synerx Pharma announces the approval of on of their first ANDAs submitted, Tesotosterone Cypionate Injection, USP (ANDA 40-652). We and our Board of Directors are happy with the continued progress Synerx Pharma has made in the short time since our founding.
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced it has launched a certain topical anesthetic product used in a variety of hospital and outpatient settings. Sales of the topical anesthetic product were $10 million in 2007, according to Wolters Kluwer...
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Generic pharmaceutical producers have grown in importance in recent years despite or because of intellectual property rights, and at their annual meeting this week in Geneva they attracted the leaders of the primary intergovernmental institutions engaged in IP rights policy...
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Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted approval for Akorn's Abbreviated New Drug Application for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%...
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Apotex Corp. announced today that the U.S. Court of Appeals for the Federal Circuit in the case of Bristol Myers Squib/Sanofi v. Apotex, Inc. has found that U.S. Patent 4,847,265 covering Plavix is valid and enforceable...
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Gilead Sciences, Inc. today announced that it has filed a lawsuit in U.S. District Court in New York against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for infringement of U.S. Patent Numbers 6,642,245 and 6,703,396. Both patents are associated with emtricitabine, a component of Truvada (emtricitabine and tenofovir disoproxil fumarate), and are licensed exclusively to Gilead Sciences by Emory University....
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Hi-Tech Pharmacal Co., Inc. announced that the United States District Court denied Hi-Tech's motion for a preliminary injunction, permanent injunction, and declaratory judgment, and granted Apotex's motion for summary judgment, and entered summary judgment in favor of the FDA....
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Bristol-Myers Squibb Co. and Sanofi-Aventis won an appeals court ruling Friday that will help them block generic competition to the blood thinner Plavix, the world's No. 2 selling-drug, in the U.S. until 2011.
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On December 12, 2008, FDA granted tentative approval for efavirenz 100 mg scored tablets, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, facilitating pediatric treatment. The product is manufactured by Aurobindo Pharma Limited, Hyberdad, India.
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MDRNA, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009. ...
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ViroPharma Incorporated today provided the following update regarding Vancocin (vancomycin hydrochloride capsules). ...
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Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for galantamine hydrobromide extended-release capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantamine hydrobromide extended-release capsules are the generic equivalent to Ortho McNeil Janssen' Razadyne(R) ER, galantamine HBr extended-release capsules, which are indicated for the treatment of Alzheimer's isease. Watson intends to launch the product immediately. Razadyne(R) ER had annual sales of approximately $112 million for the twelve months ending September 2008, according to IMS sales data.
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Synerx Pharma, LLC announces the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin(TM), Covidien (formerly US Surgical)). This ANDA submission is the culmination of a four year joint effort by Synerx Pharma, LLC and its exclusive raw material supplier Apicore, LLC. According to Synerx Pharma and Apicore, the active ingredient is extremely difficult to synthesize. Synerx Pharma stated that this product fits nicely into their Company's strategic direction; it is a difficult to produce product, serves a critical medical need, and represents an unmet market need.
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Akorn, Inc. today provided the following response regarding FDA's draft guidance on vancomycin hydrochloride capsules. The FDA has posted draft guidance for establishing bioequivalence for vancomycin HCl capsules. ...
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Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ursodiol 300 mg Capsules, the generic equivalent of Actigall marketed by Watson Pharmaceuticals. According to Wolters Kluwer, combined sales of generic and brand Ursodiol were $128.2 million for the 12 months ending October 2008....
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A two-year-old lawsuit that argues against rules governing the entrance of generics into the Canadian marketplace goes to a federal court today, the Canadian Press reports. At issue - generic drugmakers want to shorten the amount of time given brand-name drugmakers for patent protection.
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Australian drug developer, Alchemia Limited, today announced the achievement of a significant milestone towards the commercialisation of its lead product, generic fondaparinux...
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Nycomed U.S. has filed a patent infringement lawsuit in the United States against Glenmark Generics Ltd, a unit of Glenmark Pharmaceuticals Ltd, the Indian firm said in a statement on Wednesday.
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Pharma Major, Lupin Ltd. announced today that it has settled all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough's "Clarinex" tablets...
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Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. announced today that the U.S. Federal Trade Commission has accepted the proposed consent order in connection with the pending acquisition of Barr by Teva and granted early termination of the Hart Scott Rodino waiting period....
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Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. announced today that they received approval from the European Commission to proceed with Teva's acquisition of Barr....
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Warner Chilcott Limited today announced that its subsidiary Warner Chilcott Company, Inc. and Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc. have entered into a Settlement and License Agreement to resolve the pending patent litigation involving Warner Chilcott's oral contraceptive product, Femcon Fe...
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Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd., a subsidiary of Hospira, Inc., have filed lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers Doryx, a tetracycline-class oral antibiotic...
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Dr. Reddy's Laboratories today announced that it has entered into agreements with Schering and Sepracor which will allow Dr. Reddy's to manufacture and market generic versions of the CLARINEX-D-12 Hour and CLARINEX-D-24 Hour products, with six months marketing exclusivity, and the CLARINEX REDITABS product, with six months marketing co-exclusivity, starting in 2012...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base. The brand product had annual sales of approximately $3.8 billion in the United States for the twelve months that ended September 30, 2008, based on IMS sales data. Final approval of this product is expected upon resolution of patent litigation....
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Aurobindo Pharma Limited is pleased to announce that it has received the approval for its Abbreviated New Drug Submission Terbinafine Tablets 125mg and 250mg from Health Canada....
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Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for having inadequate or not enough eyelashes. LATISSE(TM) is the first and only science-based treatment approved by the FDA to enhance eyelash prominence as measured by increases in length, thickness and darkness of eyelashes. ...
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King Pharmaceuticals, Inc. and Alpharma Inc. today announced that the U.S. Federal Trade Commission has provisionally accepted a proposed consent order for public comment and has terminated the Hart-Scott-Rodino waiting period applicable to King's proposed acquisition of Alpharma....
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German tycoon Adolf Merckle might have to sell his generic drugs maker Ratiopharm as part of a broader financial rescue package agreed with creditor banks, two sources close to the matter told Reuters on Saturday....
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Drug developer Perrigo Co. said Monday it received Food and Drug Administration for its version of Wyeth's Advil PM tablets....
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Actavis Inc. today announced that it has reached agreement on a Consent Decree of Permanent Injunction with the Food and Drug Administration (FDA) regarding the company's Actavis Totowa LLC subsidiary. This agreement, in effect, settles the issues identified by the Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe....
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Watson Pharmaceuticals, Inc., a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg. Desogestrel/ethinyl estradiol and ethinyl estradiol tablets, USP, is the generic equivalent to Duramed Pharmaceuticals' Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy....
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In a Form 8-K, Medicis Pharmaceutical Corporation today announced that it has received a Paragraph IV Patent Certification from Barr Laboratories, Inc...
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Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received final approval from the U.S. Food and Drug Administration (FDA) on December 29, for its Abbreviated New Drug Application (ANDA) for Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg....
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King Pharmaceuticals, Inc. today announced the successful completion of the tender offer by King's wholly-owned subsidiary, Albert Acquisition Corp., for all outstanding shares of Class A Common Stock of Alpharma Inc. for $37.00 per share in cash. The tender offer expired at 10:00 a.m., New York City time, on December 29, 2008....
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Actavis has acquired the brand name drug Kadian from King Pharmaceuticals for not more than USD127.5M, based on quarterly sales related milestones, ending 30 June 2010....
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AstraZeneca is considering joining several of its peers in pursuing "biosimilars" -- generic versions of high-priced biotechnology drugs....
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Watson Pharmaceuticals, Inc., a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths...
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Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approvals for two Abbreviated New Drug Applications for Sterile Vancomycin HCl USP, 500 mg/vial, 1 g/vial and Sterile Vancomycin HCl USP, 5 g/vial Pharmacy Bulk Package...
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IMPAX Laboratories, Inc. today announced that Warner Chilcott Laboratories Ireland Limited, Warner Chilcott Company, Inc., Warner Chilcott (US) LLC, and Mayne Pharma International PTY. LTD have filed suit for patent infringement in the United States District Court for the District of New Jersey based on the Company's submission of Abbreviated New Drug Application for doxycycline hyclate delayed-release tablets (75 and 100 mg), generic of Doryx, to the Food and Drug Administration...
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