Generics Industry News Search
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September 2009 News Archive |
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India's Ranbaxy Laboratories said it has got orders from the national government to supply the generic version of Roche's anti-viral Tamiflu, used to treat the H1N1 flu....
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Daiichi Sankyo Company Limited and Ranbaxy Laboratories Limited announced today that Terapia S.A., a subsidiary of Ranbaxy in Romania, will market the osteoporosis medication, Evista in Romania. This is the first time in Europe that Daiichi Sankyo and Ranbaxy are leveraging synergies generated through the Hybrid Business Model....
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More appeals pending, domestic manufacturing some way off. In a victory for Indian drug companies, patent protection has been refused to Tenofovir, an anti-AIDS medicine of the US-based Gilead Sciences. The decision was taken by the patent office here....
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Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited, Gurgaon, India, announced an agreement with Validus Pharmaceuticals LLC (Validus) to market and distribute an authorized generic version of Rocaltrol (calcitriol) in both softgel capsules and an oral liquid formulation...
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The Medicines Company today announced that it has received Paragraph IV Certification notice letters from Teva Parenteral Medicines, Inc. (TPM) and Pliva Hrvatska, d.o.o. (Pliva) notifying the Company that TPM and Pliva have submitted Abbreviated New Drug Applications to the U.S. Food and Drug Administration for approval to market generic versions of Angiomax...
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Orion and Hospira, Inc. sue Sandoz companies in the U.S. to enforce their U.S. Patents covering the proprietary drug Precedex. Orion states the realisation of generic competition is neither certain nor imminent. Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce Orion's U.S. Patent No.4,910,214 and Orion's and Hospira's commonly owned U.S. Patent No. 6,716,867 against Sandoz International Gmbh and Sandoz Inc.
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Tenofovir Disoproxil Fumarate is a drug highly recommended by the World Health Organisation (WHO) for the treatment of HIV/AIDS. Till date, the medicine has been mostly marketed by Indian pharmaceutical companies through a voluntary licence scheme negotiated with the California-based Gilead Sciences few years back. Before the product patent regime had been introduced in India in 2005, the country allowed local generic manufacturers to sell cheap versions of Aids drug cocktails, known as antiretrovirals...
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Drug maker Pfizer Ltd plans to launch two or three generic drugs in India by December as part of its efforts to widen its portfolio and market share, its managing director said late on Friday....
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Aurobindo Pharma Limited is pleased to announce that it has received the final approval for Risperidone Oral Solution 1mg/mL (ANDA No. 78-452) from the US Food & Drug Administration (USFDA).
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Cipla has entered into a 50:50 joint venture with a Chinese company for bio-similars. The joint venture would be called Biomab. Cipla has said it was looking to bring out the JV's first product by 2010....
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Ortho-McNeil Pharmaceutical will get another chance to block generic copies of its pain drug Ultracet that already are on the market after winning an appeal of a district court's decision to invalidate certain claims of a patent on the drug. ...
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Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009. Interest in these formulations is partly inspired by the number of controlled-release drugs that will soon lose patent protection...
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Sanofi-Aventis has taken its share of licks in its long-running battle with drugmakers selling generic versions of Eloxatin, a drug used to treat colon cancer. Last year, in a Hatch-Waxman Act ruling, a New Jersey federal district court judge found that the generics did not infringe Sanofi's patents. Then last month, the Food and Drug Administration approved the generic drugs for sale despite an appellate ruling granting Sanofi a stay of the district court order. But Sanofi finally got some good news Thursday when the U.S. Court of Appeals for the Federal Circuit vacated the lower court's ruling and remanded the case....
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Warner Chilcott plc announced today that one of its subsidiaries has filed two lawsuits against Lupin Limited and its wholly owned subsidiary Lupin Pharmaceuticals, Inc. in the District Court for the District of Delaware for infringement of Warner Chilcott's U.S. Patent Nos. 5,552,394 and 6,667,050, which cover oral contraceptives Loestrin 24 Fe and Femcon Fe, respectively. ...
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Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets. Nateglinide is a generic version of Novartis' Starlix. Annual U.S. sales of Starlix are approximately $124 million, according to IMS Health data. Par will begin shipping the 60mg and 120mg strengths of nateglinide to the trade immediately....
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Synthon is announcing that it has successfully completed multiple decentralized procedures (DCP) for Raloxifene. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Synthon's Raloxifene 60 mg tablets are a fully generic and bioequivalent version of the brand product Evista...
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Mumbai-based pharma firm Lupin has reached an out-of court settlement with Swiss pharma major Novartis for the latter's hypertension drug sold under the brand name Lotrel, which will allow the Indian firm to launch the generic version of the drug ahead of its patent expiry in 2017 and get a one-time revenue upside, said a person familiar with the development...
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Mylan Inc. today announced that the U.S. Food and Drug Administration has accepted for filing Mylan Pharmaceutical Inc.'s abbreviated new drug application for Glatiramer Acetate Injection (20 mg/mL), a generic version of Teva's Copaxone, a product indicated for the treatment of multiple sclerosis...
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Dr Reddy's Laboratories Ltd has launched a generic version of Novartis' diabetes fighter in the United States, a spokesman for the Indian drugmaker said on Monday, sending its shares up 1.7 percent in a weak market...
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A federal appeals court has reversed a decision giving Teva Pharmaceutical Industries Ltd. and other drug-makers the right to make a generic form of a Sanofi-Aventis drug to treat stage 3 colon cancer....
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NYSE-listed Dr Reddy's Laboratories (DRL) is embroiled in a fresh patent infringement row with US-based drug-discovery firm Albany Molecular Research (AMRI). ...
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Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.
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The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) today announced that it has received approvals from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Applications (ANDAs) for Piperacillin and Tazobactam for Injection. These approvals cover Orchid's generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g (Pharmacy Bulk Package) dosage forms and strengths....
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AstraZeneca has filed for summary judgment in a U.S. patent dispute over its blockbuster cholesterol drug Crestor in a bid to bring the case to speedy conclusion....
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Dey, L.P. today announced that it has settled a lawsuit brought against it and other companies by the State of Utah in October 2005 pertaining to Medicaid reimbursements paid by the state to pharmacists and other healthcare providers. In exchange for a full release of claims, Dey has agreed to pay approximately $1 million....
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Ranbaxy Laboratories Limited announced today that the Company has entered into a strategic in-licensing agreement for the Indian market, with Medy-Tox Inc. South Korea's largest Botulinum–Toxin specialized Biotech Venture, for its cosmetic product, Neuronox. The introduction of this new alternative brand of Purified Botulinum Toxin Type A, will strengthen the Company's presence in the Dermatological segment.
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Glenmark Generics Limited's (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Verapamil 240mg Extended Release tablets and will immediately commence marketing and distribution in the U.S. market....
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The Chennai-based integrated pharma major, Orchid Chemicals & Pharmaceuticals Ltd today announced that it has received the final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Zaleplon Capsules, 5 mg and 10 mg....
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Aurobindo Pharma has received the tentative approval for Atomoxetine Hydrochloride Capsules 10mg, 18mg , 25mg , 40mg, 60mg, 80mg and 100mg and final approvals for Ribavirin Tablets 200mg and Ribavirin Capsules 200mg from the US Food & Drug Administration (USFDA). ...
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Sun Pharmaceutical Industries, the country's most valued drug maker, aims to file 30 applications in the US for manufacturing and marketing of its generic products, company CMD said. ...
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Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Galderma Laboratories, L.P. in connection with its ORACEA (doxycycline) delayed-release capsules, 40 mg. ...
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Perrigo Company today announced that it has purchased the ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel from KV Pharmaceutical for $14 million in cash at closing and a $2 million milestone payment upon the completion of a successful technical transfer. This product is the AB-rated equivalent to Stiefel Laboratories' Duac gel, indicated for the topical treatment of inflammatory acne vulgaris...
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City-based drug firm Natco Pharma will make ten million strips of its generic version of Roche's swine flu medicine Tamiflu available by October....
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Companies of interest to big pharma tend to be those that have one or two late-stage clinical programs with NCEs or biological entities. Several primary business screens require an entity to occupy a therapeutic niche supplementary/complementary to the suitor's therapeutic portfolio, an annual prospective market of at least $500 million, and a credible prospect of FDA approval...
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Sandoz announced today that it has completed its USD 1.3 billion acquisition of Ebewe Pharma's specialty generic injectables business, paving the way for the creation of a global center of excellence in generic oncology injectables...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDA's Orange Book for Eli Lilly's Evista (raloxifene hydrochloride) Tablets in litigation concerning Teva's abbreviated new drug application to market a generic version...
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Astellas Pharma Inc. and its US affiliate Astellas Pharma US, Inc. jointly filed a patent infringement lawsuit in the US against Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, Inc. regarding its submission of an abbreviated new drug application (ANDA) for a generic version of Astellas's solifenacin succinate tablets sold under the trademark VESIcare...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a July 1, 2008 decision by the District Court to grant AstraZeneca's motion for summary judgment of no inequitable conduct related to U.S. Patent No. 4,879,288. As a result of today's decision, Teva expects to market its generic version of AstraZeneca's antipsychotic agent Seroquel (Quetiapine Fumarate) Tablets no later than March 2012, when the patent is otherwise set to expire.
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On September 24, 2009, the US District Court for the District of Columbia denied Wyeth Pharmaceutical's motion for a Temporary Restraining Order. Wyeth's request for TRO was filed in connection with its lawsuit against the US FDA challenging the US FDA's approval of Orchid's ANDAs for its generic products, Piperacillin and Tazobactam for Injections. The Court rejected Wyeth's requests and denied the TRO. In its Memorandum Opinion and Order, the Court found that "Wyeth has failed to demonstrate a likelihood of success on the merits" of its claim that the US FDA's approval of Orchid's ANDAs violated applicable US statutes.
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AstraZeneca today announced that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving Seroquel (quetiapine fumarate) tablets. In July 2008, AstraZeneca announced that the US District Court for the District of New Jersey granted the company's Motion for Summary Judgment of No Inequitable Conduct in litigation involving Teva Pharmaceutical Industries Ltd. and Sandoz, Inc...
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Actavis today announced the launch of the antiepileptic drug Topiramate in the UK, Germany, France and Switzerland. The product was launched on day one as the originator's patent expired on 25 September. Actavis was first to market in all four countries...
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Taro Pharmaceuticals Industries Ltd. sued Sun Pharmaceutical Industries Ltd., claiming the Indian drugmaker's tender offer for Taro failed to disclose key information. ...
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Watson Pharmaceuticals, Inc., a leader in generic and specialty branded pharmaceuticals, announced findings of a double-blind study which demonstrate that GELNIQUE was comparable to placebo in its effect on memory tests and other cognitive functions in older healthy adult subjects when compared to immediate release oral oxybutynin treatments. The results were presented at the International Continence Society Annual Meeting....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg....
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Hospira, Inc., a global specialty pharmaceutical and medication delivery company, today announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o. (Zagreb, Croatia), a move that will help extend Hospira's reach and vertical integration in biogenerics. Financial terms of the agreement were not disclosed....
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