Generics Industry News Search
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May 2014 News Archive |
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Plaintiffs who took the generic version of the osteoporosis drug Fosamax are pre-empted by federal law from pursuing litigation against its manufacturers, says an appellate court, in upholding a lower court ruling...
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Avanir today announced that the U.S. District Court for the District of Delaware has ruled in favour of Avanir in the company's patent infringement lawsuit against Par Pharmaceuticals and Impax in conjunction with their ANDA for generic versions of Nuedexta (Dextromethorphan hydrobromide/Quinidine sulfate) capsules for the treatment of pseudobulbar affect...
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The FDA denied two Citizen Petitions -- including one filed by Eisai and Arena Pharmaceuticals...
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Indian drugmaker Ranbaxy Laboratories started recalling 29,790 packs of an allergy-relief medicine in the United States...
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A huge spurt in infringement suits (stay orders) recently against domestic drug companies highlight that multinational firms are increasingly using the right to information (RTI) route to enforce intellectual property and block entry of affordable generics...
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Dublin-based Amarin has filed a patent infringement case against Dr Reddy's alleging that the latter is attempting to come out with generic versions of its patented drug Vascepa...
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The health ministry has reopened the issue of waiving a global drug giant's patent rights for Dasatinib, a cancer drug, arguing the move is needed to deal with an "emergency"...
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U.S. regulators plan an extensive study of blood-pressure drugs that generate almost 40 million prescriptions a year, after receiving thousands of complaints from doctors and patients...
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IGI Laboratories, a New Jersey based generic topical pharmaceutical company, today announced that it has received tentative approval from the U.S. FDA for its ANDA for Diclofenac sodium topical solution, 1.5%...
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Actavis announced today that it has launched a generic version of Boehringer Ingelheim's Catapres-TTS (Clonidine Transdermal System, USP, 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day for one week), following the receipt of final approval on its ANDA from the U.S. FDA...
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Danish pharmaceutical company H. Lundbeck is to buy Chelsea Therapeutics for up to $658 million...
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CorePharma announced the launch of Methylphenidate HCl tablets, the generic version of Novartis' Ritalin...
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India's largest generic drug maker, Sun Pharmaceutical Industries, is recalling hundreds of thousands of bottles of Cetirizine and Venlafaxine...
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Acura Pharmaceuticals, a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today that it has entered into a Settlement Agreement with Ranbaxy...
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We are pleased that a court in Norway has denied GSK's request to restrict access to Sandoz's AirFluSal Forspiro in Norway...
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Ajanta announced today the launch of Risperidone Tablets (0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg), the generic version of Risperdal...
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Vivus said on Friday drugmaker Actavis plans to market a generic version of Vivus's obesity drug Qsymia that was approved in July 2012...
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ScinoPharm Taiwan, a specialty API company, and Lee's Pharmaceutical have executed two collaboration agreements...
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Israel-based Teva Pharmaceutical Industries has complained to the US FDA that generic versions of its blockbuster drug Copaxone (Glatiramer acetate) should have clinical trials before they are approved...
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Perrigo company announced that it has received final approval from the U.S. FDA on its ANDA for Azelastine hydrochloride nasal spray (0.15%)...
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Indian drug makers, slammed for months in the US over issues related to quality and intellectual property rights, might soon get to breathe easy...
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Two months from now, Pfizer's patent for the erectile dysfunction drug
Viagra will expire and the gate holding back Chinese pharmaceutical
corporations from the coveted market will be lifted...
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Valeant Pharmaceuticals International announced today that certain of its subsidiaries have entered into settlement agreements with affiliates of Actavis related to Actavis' generic versions of Acanya Gel, 1.2%/2.5%, and Tiazac...
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Actavis today announced that it has received final approval from the FDA on its ANDA for a generic version of Mallinckrodt's Exalgo...
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Tribute Pharmaceuticals and Faes Farma announced today the signing of an exclusive license agreement that grants Tribute the exclusive right to sell Faes's Bilastine...
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Mylan today announced that it has launched Olanzapine orally disintegrating tablets...
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Sandoz Korea announces that it is launching today AirFluSal Forspiro,
an innovative new inhaler for patients with asthma and/or COPD...
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The Rituximab biosimilar, to be marketed under the trade name AcellBia, is the first mAb biosimilar to receive a positive opinion from the Russian regulatory body...
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Four medicines to treat alcoholism worked to reduce addiction, a study
found, providing evidence that may overcome skepticism and spur greater
use of the drugs...
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Teva Pharmaceutical Industries lost a bid to block approval of a generic
form of Copaxone, a multiple sclerosis drug that may account for half
the company's profit, 10 days before the patent on the medication
expires...
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Wockhardt, the Indian drugmaker whose biggest revenue-generating facility was banned by the FDA last year, is recalling some bottles of its generic version of the heart pill Toprol XL...
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Novartis has settled its litigation with the U.S. subsidiary of Sun Pharma relating to Novartis patents covering the use of certain polymorphic forms of Gleevec (Imatinib mesylate), which expire in 2019...
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Eli Lilly today announced that the English High Court has determined that the vitamin dosage regimen patents for Alimta (Pemetrexed) would not be infringed by a generic competitor that has stated an intent to market certain alternative salt forms of Pemetrexed in several European countries upon expiry of the Alimta compound patents in 2015...
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Actavis today announced that it has reached an agreement with Janssen to continue supplying the authorised generic version of Janssen's Concerta (Methylphenidate hydrochloride extended-release tablets)...
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As more modern drugs are created by biologic, rather than chemical, means, a set of proposed guidelines from the U.S. FDA this week suggests that making cheaper generic versions of those biologic drugs will be a lot more difficult...
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Abbott today announced a definitive agreement to acquire Latin American pharmaceutical company CFR Pharmaceuticals...
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Hospira, announced today it will initiate a voluntary nationwide recall to the user level for one lot of Labetalol hydrochloride injection, multidose vial, NDC 0409-2267-20, lot 36-225-DD, expiration 12/01/2015...
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Pfizer made what it's calling its fourth and final offer for AstraZeneca, submitting a proposal to buy the company for $117 billion - after previously bidding $106 billion on May 2...
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The federal government must intervene to end shortages of generic versions of the addictive painkiller OxyContin, says a Toronto man who relies on the drug...
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Neopharma has tied up with a Pfizer unit to manufacture selected products...
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A New Jersey federal judge ruled Monday that Mylan can't use documents produced during its litigation against GlaxoSmithKline - which allegedly breached a contract by allowing Apotex...
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Acura announced today that it has entered into a settlement agreement with Sandoz to settle Acura's patent infringement action pending against Sandoz...
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Prasco announced today it has entered into a distribution and supply agreement with Recordati Rare Diseases...
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Acura Pharmaceuticals has entered into a settlement agreement with Sandoz to settle Acura's patent infringement action pending against Sandoz in the US District Court for the District of Delaware...
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The price of Sildenafil is set to fall sharply after its Australian patent expired this week...
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Lung cancer has become the leading source of deaths among all types of cancer in China...
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Indian generic drug producers are devising fresh strategies to continue benefiting from the world's largest pharmaceutical market the US...
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Mapi Pharma, a developer of high-barrier to entry and high value-added generic drugs, announced today that its US patent for the company's Glatiramer acetate depot has been extended until December 2030...
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Actavis today confirmed that it has filed an ANDA with the FDA seeking approval to market Saxagliptin hydrochloride tablets...
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Shares of Celgene are volatile following the report of the Markman opinion on a patent dispute over five claims covering six patents with defendants Natco Pharma, Arrow International and Watson Laboratories seeking approval to market a generic version of Revlimid...
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Aceto today announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched the 50 mg, 100 mg and 200 mg strengths of Fluconazole tablets...
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Speculation on the near mega-merger of AstraZeneca and Pfizer may have subsided, but the companies' interests actually have aligned-albeit briefly-for today's launch of over-the-counter, 20 mg "Nexium 24HR"...
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Teva announced that the European Patent Office issued a decision in favour of Teva in a patent opposition proceeding filed by Synthon BV, Mylan and an unidentified third party...
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Hikma Pharmaceuticals ("Hikma") the fast growing multinational pharmaceutical group, today announces that it has signed an asset purchase agreement with Ben Venue Laboratories, a member of the Boehringer Ingelheim Group of Companies, to acquire assets of Bedford Laboratories, its US generic injectable business, for a total consideration of up to $300 million, which will be satisfied through an upfront cash payment of $225 million...
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Teva announced the launch of Dexmethylphenidate HCl extended-release capsules, the generic version of Novartis' Focalin XR...
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Tokyo - based Otsuka Pharma dragged Aurobindo Pharma and its two subsidiaries - Aurobindo Pharma USA, and Aurolife Pharma - to the US District Court of New Jersey over alleged infringement of patents...
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Mylan today announced that it has launched Atovaquone and Proguanil hydrochloride tablets...
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Nuvo Research today announced that a third party has received FDA approval to market and sell a topical diclofenac sodium 1.5% solution in the U.S....
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The FDA today approved the first generic versions of Celebrex (Celecoxib) capsules...
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The Delhi High Court on Friday has upheld its jurisdiction to hear Teva's appeal against Natco Pharma...
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Mylan today commented on the decision by the U.S. District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the U.S. FDA...
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Actavis today announced that it has entered into an agreement with Cephalon to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil...
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