Generics Industry News Search
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November 2013 News Archive |
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Mylan today confirmed that its U.S.-based subsidiary has been sued by Teijin and Takeda, in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Febuxostat tablets, 40 mg and 80 mg...
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Warner Chilcott launched suit in New Jersey federal court Wednesday alleging Mylan has infringed its patent for oral contraceptive Lo Loestrin Fe by seeking federal approval to launch a generic version of the birth control before Warner's patent expire...
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Navamedic, the Norwegian pharmaceutical products company, today announced the launch of a new generic pharmaceutical product...
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Takeda on Friday scored victories in three of its patent infringement suits in California federal court against drugmakers looking to sell a generic version of its acid reflux medicine Dexilant, convincing the court that a total of four of its patents would be infringed if the generics went to market...
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Teva on Monday asked the U.S. Supreme Court to stay an appeals court ruling that would strip its $4 billion-a-year multiple sclerosis drug Copaxone of its patent protection in 2014 rather than 2015...
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Country's largest drug maker Dr Reddy's Laboratories is set to take its complex generic drug Fondaparinux sodium injection to Canada and two other emerging markets...
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Navamedic ASA, the Norwegian pharmaceutical products company, today announced the launch of a new generic pharmaceutical product. The new generic can replace Viagra and is Navamedic's 15th product launch so far this year...
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The generic drug Gabapentin, which is already widely prescribed for epilepsy and some kinds of pain, appears to be safe and effective in the treatment of alcohol dependence...
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Indian Pharma major, Sun Pharma has received the US FDA approval to make the generic version of the scarce cancer drug Doxil ...
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Aurobindo has received ANDA approval by USFDA, for Bupivacaine hydrochloride injections, market size estimated near $25m, and Finasteride tablets, generic version of Merck’s Propecia, market size estimates near US$80mn...
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Forest Laboratories, and Forest Laboratories Holdings, Ltd. (collectively, "Forest") announced today that they have entered into a settlement agreement with Actavis, Inc. and related companies and subsidiaries thereof, in patent infringement litigation brought by Forest in response to Actavis's ANDA seeking approval to market generic versions of Forest's Bystolic (nebivolol) tablets...
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Amneal Pharmaceuticals LLC will launch its AB-rated generic for Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets) 1 mg/20 mcg, 75 mg the first week of January 2014...
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India's drug major Ranbaxy Laboratories used "fraudulent" data to get USFDA nod to sell its generic drugs, according to whistleblower Dinesh Thakur, who has also accused the drug-maker of faking test results...
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The Food and Drug Administration proposed a rule on Friday that would permit generic drug makers to update their labels if they received information about potential safety problems...
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In a decision that will cheer the domestic pharma industry, Indian firms including Dr Reddy's, Lupin and Torrent Pharma have received nod from the US health regulator to market the first generic version of Aciphex, used to treat gastroesophageal reflux disease...
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The government has rejected a compulsory licensing application by BDR Pharmaceuticals to manufacture the generic version of patented anti-cancer drug "Dasatinib", a decision that is seen as evidence that IP rules prevail in India...
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Sagent today announced the launch of Doxorubicin hydrochloride Injection, USP, an antineoplastic agent, in three vial presentations...
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Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc has launched Rabeprazole Sodium Delayed-release Tablets, 20 mg...
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Pharma Major Lupin announced today that its US subsidiary has launched its generic Rabeprazole sodium delayed‐release tablets, 20mg. Lupin had earlier received final approval from the US FDA for the same...
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A U.S. Supreme Court justice on Wednesday declined a request from Teva Pharmaceutical Industries for a stay of an appeals court ruling that would strip the company's $4 billion-a-year multiple sclerosis drug Copaxone of patent protection in 2014, rather than 2015...
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Actavis today confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Testosterone topical solution, 30mg/1.5mL...
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Cadence, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercialising proprietary products principally for use in the hospital setting, announced today that the U.S. District Court for the District of Delaware has ruled in favor of Cadence in the company's patent infringement lawsuit against Exela...
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AstraZeneca and three generic-drug makers must face class-action allegations they overcharged consumers by delaying low-cost versions of the heartburn medication Nexium for six years, a judge ruled...
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Teva Pharmaceutical Industries Ltd. announces today that the U.S. Food and Drug Administration has granted approval of the generic equivalent to TOBI (Tobramycin Inhalation Solution USP) in the United States...
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Generic drug maker Akorn said it has bought the U.S. rights to three branded ophthalmic products from Merck for $52.8 million...
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Mylan today announced that its subsidiary has launched Dexmethylphenidate hydrochloride Extended-release capsules, 30 mg, which is the first generic version of Novartis' Focalin XR...
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Ranbaxy, the global generic arm of Japan's second-largest pharmaceutical company, Daiichi Sankyo, plans to supply medicines to the Land of the Rising Sun from its Indian facilities, according to sources...
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Intellipharmaceutics a pharmaceutical company specialising in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs today announced that the U.S. Food and Drug Administration has granted final approval of the Company's Dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths...
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IDT Australia has filed for approval to market generic Temozolomide in the US once the drug goes off-patent in the market next year...
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A New Jersey federal judge on Monday released Daiichi Sankyo from multidistrict antitrust litigation challenging a patent infringement settlement between Pfizer and Ranbaxy over Pfizer's cholesterol drug Lipitor, in which Daiichi Sankyo claimed it had no involvement...
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Avesthagen Pharma AG has announced an agreement with Elpen Pharmaceutical Co Inc, a leader in life-sciences for the distribution of Avdesp, a biosimilar product in seven EU and six non-EU territories...
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Perrigo Company announced that it has filed with the U.S. FDA an ANDA for Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% and has notified Dow Pharmasciences, the owner of the NDA of its filing...
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The Intellectual Property Appellate Board has revoked a patent of US-based biotechnology firm Kibow Biotech Inc in India, titled "Prebiotic and Probiotic Compositions and Methods for their Use in Gut-Based Therapies", finding that the invention claimed is obvious...
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Impax, today announced that it is commencing shipment of generic Solaraze (Diclofenac sodium gel, 3%), a first-to-file product, through Global Pharmaceuticals, Impax's generics division...
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Two months after the Swiss innovator firm Roche threw in a surprise by announcing that it would no longer pursue a patent on breast cancer drug Herceptin in India, it will have to brace up for generic competition, probably much earlier than it anticipated...
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Horizon notified by counsel for Par that Par elected to withdraw ANDA with the FDA for a generic version of Rayos, on October 22 filed suit in district court of New Jersey against Par in response to a paragraph IV patent certification...
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A US-based patient rights group said Saturday it has sought to block a bid by California-based Gilead Sciences to obtain an Indian patent for a potentially blockbuster drug to treat hepatitis C...
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Teva and Mylan today announce that certain of their affiliates have agreed to settle and dismiss pending patent litigation involving Copaxone (Glatiramer acetate) in the United Kingdom, the Netherlands and France relating to non-infringement and the validity of European Patent 0,762,888, which expires in May 2015...
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Mylan today announced that its partner Biocon has received approval for a Mylan-Biocon Trastuzumab product from the Drug Controller General of India...
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The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application...
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