Generics Industry News Search
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July 2013 News Archive |
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The European Medicines Agency's Committee for Medicinal Products for Human Use has issued positive opinions on biosimilar versions of Johnson & Johnson's arthritis and Crohn's disease treatment Remicade (Infliximab) filed by Celltrion Healthcare and Hospira...
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Pfizer launched a series of patent infringement suits Friday in Delaware federal court against Amneal, Impax and other generic-drug manufacturers for seeking approval for their own versions of Pfizer's overactive-bladder medication Toviaz...
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AstraZeneca and Pozen on Friday sued Mylan in New Jersey federal court, alleging the generic-drug maker had infringed on seven patents with its planned generic version of arthritis treatment Vimovo...
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Glenmark announced today that the United States Food and Drug Administration has granted final approval for Rizatriptan benzoate orally disintegrating tablets, its generic version of Merck's Maxalt MLT tablets...
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Par and Alkermes brought patent infringement allegations in New Jersey federal court Thursday against Breckenridge over the company's plans to make a generic version of the appetite stimulant drug Megace ES...
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Depomed today announced that it has received a Paragraph IV certification notice from Banner advising Depomed that Banner has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Zipsor (Diclofenac potassium) liquid filled capsules, 25 mg...
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Teva, the world's largest generic-drug maker, was sued for patent infringement by a U.S. unit of UCB in a bid to block plans to copy the epilepsy drug Vimpat...
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The U.S. Department of Health and Human Services and the board of trustees for the University of Illinois slapped Lupin with a patent infringement lawsuit Monday for allegedly trying to create and market generic versions of HIV drug Prezista...
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Sandoz today announced the US launch of Metronidazole 1% topical gel, the first generic version of Metrogel 1%...
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Mayne is pleased to announce that it has acquired US-based Libertas...
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Impax Laboratories today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Toviaz (fesoterodine fumarate extended-release tablets, 4 mg and 8 mg)...
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The FDA on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago...
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Novartis sued Intas for patent infringement, claiming it sought U.S. approval to sell a generic version of the immunosuppressant drug Myfortic before Novartis's patents expired...
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Orexo today announced that it has received approval from the U.S. Food and Drug Administration for Zubsolv (Buprenorphine/Naloxone) sublingual tablet CIII...
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Sunovion's bronchitis and emphysema drug Brovana infringed Mylan's patents, a judge ruled...
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Eli Lilly and Boehringer Ingelheim today announced that the companies' marketing authorisation application for LY2963016, an investigational basal (long-acting) Insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency...
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Everett Laboratories, a leader in the field of nutritional products and prenatal supplementation, today formally announced that it has filed three patent infringement lawsuits and associated motions for preliminary injunctions in the United States District Court for the District of New Jersey against Acella Pharmaceuticals...
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Describing 2012 as a "banner year" for patent litigation in the US, a new report from PricewaterhouseCoopers says the number of patents granted and the number of patent lawsuits filed were both up during the year, even as the damages awarded in such suits hit all-time highs...
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Generics giant Teva will double production capacity in Japan, also with eye on China...
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Mayne is pleased to announce the launch of Doxycycline Hyclate Delayed-Release 75mg and 100mg Tablets, in the United States via its generic products division...
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Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that its generic pharmaceuticals business has launched Dextroamphetamine sulfate oral solution, the first-to-market generic equivalent of ProCentra, which is indicated for the treatment of attention deficit disorder with hyperactivity (ADHD) and narcolepsy...
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Actavis today announced that it has received approval from the U.S. FDA on its Abbreviated New Drug Application (ANDA) for Oxymorphone hydrochloride extended-release tablets, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg...
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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 Lacosamide tablets...
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umbai-based Glenmark confirms that it has filed Abbreviated New Drug Applications for Lacosamide tablets and oral solution with the US drug authorities with a Paragraph IV certification for the Orange-Book listed patent...
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Sun said on Friday that it had received final approval from the US Food and Drug Administration to sell the generic version of Novo Nordisk's anti-diabetic drug Prandin in that country...
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Medicines Co received an unfavorable claim construction ruling from a Delaware district court Thursday as part of a patent lawsuit over proposed generic versions of the drug maker's blood-thinning drug Angiomax...
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Dr. Reddy announced today that it has launched Decitabine for injection (50mg) a therapeutic equivalent generic version of Dacogen in the US market on July 11, 2013, following the approval by the USFDA...
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Bayer has agreed to pay $74 million to settle a California consumer class action over its alleged pay-for-delay patent deals for blockbuster antibiotic Cipro, according to documents filed Thursday...
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Mylan today confirmed that the company has been sued by UCB, Research Corporation Technologies and Harris in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg...
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Mylan today announced that its U.S.-based subsidiary has launched Fenofibric acid delayed-release capsules, 45 mg and 135 mg...
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Actavis today announced that it has received approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Lamotrigine orally disintegrating tablets, 25 mg, 50 mg, 100 mg and 200 mg, a generic equivalent to GlaxoSmithKline's Lamictal ODT...
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Impax announced that it is commencing shipment of authorised generic Trilipix (Fenofibric acid) delayed release capsules, 45 mg and 135 mg, through Global Pharma, Impax's generics division...
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Mylan today announced that its U.S.-based subsidiary has launched Norethindrone tablets USP, 0.35 mg...
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Mylan today announced that Judge Katherine Forrest of the U.S. District Court for the Southern District of New York has dismissed Teva's lawsuit alleging that Mylan's Abbreviated New Drug Application ("ANDA") for its generic version of Copaxone (Glatiramer acetate) would infringe four patents held by Teva...
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The letter, sent to a New Jersey manufacturing site owned by Indian manufacturer Cispharma, explains that during a March/April 2013 inspection, FDA inspectors identified "significant violations" of current good manufacturing practices (CGMPs)...
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Mylan today announced that the United States District Court for the Northern District of West Virginia has granted Mylan's motion for partial summary judgment finding that the production and marketing of Teva's generic version of Mylan's Perforomist Inhalation Solution infringes one of Mylan's Orange Book listed patents (U.S. Patent No. 6,667,344) on Perforomist...
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Novartis generics subsidiary Sandoz has started a late-stage trial of its biosimilar version of Amgen and Pfizer's blockbuster arthritis drug Enbrel (Etanercept)...
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Par today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid EQ 45 mg and EQ 135 mg delayed-release (DR) capsules...
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Perrigo today announced that it has received tentative approval from the U.S. Food & Drug Administration for its abbreviated new drug application for Repaglinide tablets, the generic equivalent to Prandin tablets (Repaglinide tablets)...
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Available only to the public health sector and authorised, non-retail prescribers, Lyza (Norethindrone tablets USP, 0.35 mg) is an AB rated, generic contraceptive...
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A Delaware federal judge on Monday ruled that Mylan infringed three patents for Cephalon's cancer painkiller drug Fentora, saying the former company's proposed generic version of the drug includes components covered by the patents...
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Forest announced today that they have entered into a settlement agreement with Amerigen in patent infringement litigation brought by Forest in response to Amerigen's ANDA seeking approval to market generic versions of Forest's Bystolic (Nebivolol) tablets...
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Natco has dropped plans to launch a biosimilar version of breast cancer drug Abraxane, after having successfully challenged the innovator's patent and promised a generic copy at one-fifth the price...
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Lupin, one of the leading pharmaceutical companies in India, gained on Tuesday after it received final approval from the United States Food and Drugs Administration for its metformin hydrochloride extended release tablets (HCl ER) 500 mg and 1000 mg...
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Mylan today announced that the Third Circuit Court of Appeals has reversed a summary judgment ruling dismissing Mylan's claim for breach of contract against GlaxoSmithKline relating to Paroxetine hydrochloride extended-release (ER) tablets...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has entered into a settlement agreement with OSI, Pfizer and Genentech that will resolve patent litigation related to Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg...
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Cornerstone filed a complaint earlier today in the United States District Court for the District of Delaware alleging that Exela infringed its U.S. Patent Nos. 7,612,102 and 7,659,291 by filing a Supplemental New Drug Application with the FDA seeking approval to market a ready to use injectable formulation of 0.1 mg/ml and 0.2 mg/ml Nicardipine hydrochloride in 0.9% sodium chloride...
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Mylan Inc. today confirmed that Mylan Pharmaceuticals Inc. and Orion Corporation have entered into a settlement and license agreement settling the parties litigation in connection with Mylan's filing of an ANDA with the U.S. FDA for Carbidopa/Levodopa/Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg...
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Teva and Lonza today announced that following a strategic review of the Teva-Lonza Joint Venture (TL-JV), the companies have decided to discontinue their collaboration for the development, manufacturing and marketing of biosimilars...
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Mylan today confirmed that the company has been sued by Eisai and Novartis in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Rufinamide tablets, 200 mg and 400 mg...
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Depomed today announced it has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Banner and Watson. Banner Pharmacaps has filed an Abbreviated New Drug Application (ANDA) with the FDA to market generic Zipsor (Diclofenac potassium) 25mg capsules and has granted to Watson exclusive rights to the proposed generic product...
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Mylan today announced the U.S. Court of Appeals for the Federal Circuit has reversed a district court's finding related to Teva's U.S. Patent 5,800,808 for Copaxone, thereby invalidating the patent...
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Teva announced that the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Southern District of New York in the appeal filed by Momenta / Sandoz and Mylan / Natco regarding the validity and infringement of four patents for Teva's relapsing-remitting multiple sclerosis (RRMS) product, Copaxone (Glatiramer acetate injection) that expire in May 2014...
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Natco is pleased to announce the US Court of Appeals for the Federal Circuit ruling, reversing a district court's finding related to Teva's US Patent for Copaxone...
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Dr. Reddy's announced today that it has launched Donepezil hydrochloride tablets, 23 mg, a therapeutic equivalent generic version of Aricept, 23 mg in the US market on July 27, 2013, following the approval by the United States Food & Drug Administration of Dr. Reddy's ANDA for Donepezil hydrochloride tablets, 23 mg...
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Teva announced today that the Court of Appeal for England and Wales has found in favor of Teva, upholding the validity of the asserted claims of UK patent 762,888 relating to Copaxone (Glatiramer acetate injection), following an appeal brought by Generics [UK] Limited, a subsidiary of Mylan...
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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 Tapentadol Extended-release Tablets 50 mg, 100 mg, 150 mg and 200 mg...
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Pfizer, in what could be the prelude to spinning off its generics drug business, said it plans to separate its commercial operations into two units, mainly for patent-protected brands and a third for generics...
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Perrigo, a U.S. maker of over-the-counter medicines, agreed to buy Irish drug company Elan for $8.6 billion, gaining a low-tax base for international expansion...
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Perrigo today announced that it has received final approval for its abbreviated new drug application for Fluticasone propionate lotion, 0.05%, the generic equivalent to Cutivate Lotion, 0.05%...
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Pharma Major Lupin announced today that its U.S. subsidiary, Lupin has received tentative approval for its Armodafinil Tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths as well as another tentative approval for its Doxycycline Capsules, 40 mg (30 mg Immediate-release and 10 mg Delayed-release) from the United States FDA...
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Amerigen today announced it had entered into a collaboration agreement with Forest Laboratories regarding the development of a number of specialty generic products. Under the terms of the agreement, Amerigen will use its formulation expertise to develop a range of complex generic products and will commercialise such products in the United States...
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