Generics Industry News Search
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June 2013 News Archive |
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US pharmaceutical giant Merck Sharp and Dohme (MSD) said it is "concerned" about the "blatant" patent violation in India over two of its blockbuster anti-diabetes drugs Januvia and Janumet...
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Fujifilm and Dr. Reddy's have decided to terminate the Memorandum of Understanding (MoU) to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture in Japan...
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A European regulator will fine Denmark's Lundbeck and eight other makers of generic drugs for limiting the supply of cheaper medicines, two people with knowledge of the matter said, its first sanction against "pay-for-delay" deals...
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Shire on Friday urged a California federal court to throw out putative class allegations that the drug company stifled competition for Adderall XR through patent settlements and supply agreements with generic-drug makers, saying its conduct did not delay entry of a generic...
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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the tocolytic agent Atosiban SUN (Sun)...
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India, known as the "pharmacy to the world", today defended its lucrative generic drug industry as safe and strongly regulated after the nation's biggest drug firm pleaded guilty to US charges of making adulterated medicines...
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AstraZeneca today announced it has entered into an agreement with Hanmi and its US marketing partner Amneal to resolve certain issues and appeal others in US Nexium patent litigation regarding Hanmi's Esomeprazole Strontium NDA product...
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Aceto today announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, launched the 0.025% strength of Flunisolide nasal solution USP, an FDA approved generic version of Nasalide...
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One company threatened to sue 8,000 coffee shops, hotels and retailers for patent infringement because they had set up Wi-Fi networks for their customers...
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In comments to the Food and Drug Administration, drug companies said the draft guidance for industry on formal meetings between the agency and biosimilar product sponsors needs some revisions...
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Endo today outlined the strategic, operational and organisational steps it is taking to refocus the Company and drive shareholder value...
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Pharmacists will be legally obliged to substitute branded medicines with cheaper, generic drugs within months...
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A Kenyan drug maker Biodeal Laboratories is set to unveil a multi-billion shillings manufacturing plant in Thika as pharmaceutical companies strive to meet the growing demand for affordable medicine...
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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 Drospirenone/Ethinyl Estradiol/Levomefolate calcium tablets And Levomefolate calcium tablets...
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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 Propofol Injection 10mg/mL....
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Pharmaceuticals maker AbbVie on Wednesday accused Dr. Reddy of infringing three drug patents by seeking approval for a generic version of the hyperactive-thyroid medication Zemplar, according to a suit filed in Delaware federal court...
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Claris announced today that it has received an ANDA approval for Levofloxacin injection, having a strength of 25mL/mL in 20mL vials in the USA...
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Teva on Wednesday agreed to a settlement with Bristol-Myers Squibb and Merck, ending claims in New York federal court that its planned generic version of HIV treatment Atripla had infringed two patents...
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Teva, the world's largest maker of generic drugs, advanced the most in three weeks on prospects the drugmaker will begin selling its generic diabetes pill in the U.S....
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In a letter to the Serbian minister of finance, Mirko Bogdanov, head of the European unit of Valeant North America, cited Valeant's recent $8.7 billion acquisition of Bausch + Lomb as one factor in the decision to rescind the offer, according to Reuters...
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The Federal Circuit on Monday affirmed the dismissal of Merck's claims that Apotex infringed one of its patents by creating a generic Nasonex spray, finding Merck hadn't supplied credible evidence of infringement...
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Aceto, today announced that Rising, its finished dosage form generics subsidiary, will launch the 50mg strength of Riluzole tablets, an FDA approved authorised generic version of Covis's Rilutek...
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Trying to limit access to Teva's emergency contraceptive Plan B One-Step and other similar birth control drugs has been a long battle, but the government has finally decided to cut its losses...
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Pfizer announced today a $2.15 billion settlement reached with Teva and Sun Pharmaceutical Industries, for patent-infringement damages resulting from their "at-risk" launches of generic Protonix in the US....
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Drug makers generally get fair warning when generics target their drugs, giving them some time to prepare for the inevitable eating away of revenues...
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In a development that could hasten the entry of the generic version of Gleevec into the US market, Indian drug major Sun Pharma has sued Novartis Pharmaceuticals Corp in the District Court of New Jersey, demanding rights to launch a generic version of the cancer drug before the Novartis patent expires...
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Today, the U.S. Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a 2-1 ruling that a claim in a Novo Nordisk patent related to the use of Repaglinide in combination with metformin for the treatment of type 2 diabetes was invalid...
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European antitrust regulators fined nine drug makers, including Denmark's Lundbeck and India's Ranbaxy, a total of 146 million euros for blocking the supply of a cheaper anti-depressant to the market, the first EU sanction against such deals
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US-based drug maker AbbVie Inc, the spun-off entity of Abbott, has dragged Dr Reddy's Lab to court for allegedly infringing the former's patented drug Zemplar on six counts concerning three patents...
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Actavis and Kissei Pharmaceutical today confirmed that they have filed lawsuits against Sandoz and Hetero Labs in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,387,603 (the '603 patent) covering Rapaflo, a treatment for the signs and symptoms of benign prostatic hyperplasia...
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Drug firm Glenmark Pharmaceuticals on Wednesday said it has received US health regulator's approval to market Riluzole tablets, used in treating nervous system disorder, in the American market...
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Europe's top antitrust enforcer continued a crackdown on drug company efforts to keep low-cost generic versions of their medicines off the market, a campaign that is taking place on both sides of the Atlantic...
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Zydus lost the patent battle in New Jersey court that enjoined Zydus from manufacture and sell of generic version of Takeda's Prevacid SoluTab...
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On June 17, the US Supreme Court held that so-called "pay for delay" or "reverse payment" arrangements between branded and generic drug manufacturers could be illegal under antitrust laws, although only after a full rule of reason test...
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When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability...
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Ahmedabad-based drug maker, Intas Pharmaceuticals and its US-based wholly owned subsidiary Accord Healthcare has entered into a settlement and license agreement with Hoffmann-La Roche to resolve pending patent litigation on Xeloda Tablets...
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The U.S. Supreme Court turned away an effort by Momenta Pharmaceuticals and Novartis's Sandoz to halt sales of a competing generic version of the blood-thinner Lovenox...
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Pfizer's patent on Viagra has expired in the UK and other states in Europe, paving the way for the erectile dysfunction dysfunction market to be flooded with generics of the blockbuster...
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MSD, a unit of U.S. drug maker Merck & Co, said it has won an injunction against India's Aprica Pharmaceuticals and a source said this will stop Aprica launching generic versions of two diabetes drugs in India...
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Eli Lilly & Co. won a U.K. patent lawsuit against a Johnson & Johnson unit over a potential treatment for Alzheimer's disease...
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Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Norethindrone Tablets USP, 0.35 mg. Norethindrone Tablets USP, 0.35 mg, are the generic version of Janssen Pharmaceuticals, Inc.'s Micronor Tablets, 0.35 mg (28-Day Cycle), which are indicated for the prevention of pregnancy...
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Dr. Reddy's Laboratories announced today that it has launched Lamotrigine Extended-Release Tablets (25 mg, 50 mg, 100 mg, 200 mg, 300 mg) a therapeutic equivalent generic version of Lamictal XR (Lamotrigine) in the US market on June 25, 2013, following the approval by the US FDA of Dr. Reddy's ANDA for Lamotrigine XR tablets...
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Mylan Inc. one of the world's leading generic and specialty pharmaceutical companies, today announced that it has launched Sildenafil Citrate Tablets, 25 mg, 50 mg and 100 mg in France, the United Kingdom, Ireland, Italy, Belgium, Slovakia, Germany, Denmark, Czech Republic, Spain and the Netherlands...
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In a bid to strengthen their case, US drug firm Merck Sharp & Dhome and Indian drug-maker Sun Pharma, who have a co-marketing tie up for Merck's diabetes drug Januvia, have now included a patent licensing agreement in their arrangement...
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Teva UK has accused Reckitt Benckiser of trying to thwart generic competition for its heartburn treatment by pulling one version of the drug from the country's official prescription list once its patent protection expired, the U.K.'s competition court said Friday...
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Merck Sharp & Dohme Corp. and Bristol-Myers Squibb Co. brought patent infringement allegations in New Jersey federal court Thursday against Indian generics maker Cipla USA over the company's plans to make a generic version of the HIV treatment Sustiva...
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