Schering-Plough has filed a patent infringement lawsuit in the US District Court for the Distirct of New Jersey against Glenmark in response to Glenmark’s ANDA submission with the US FDA seeking approval to market generic Zetia tablet, generically known as ezetimibe before expiry of the Orange Book listed patents. Zetia which is worth US $ 1.9 billion in 2006 is developed by Schering-Plough and co-marketed by Merck & Co. In its complaint, Schering-Plough alleges that Glenmark “had no adequate good faith basis” for claiming to the FDA that its version of Zetia would not infringe any valid and enforceable patents. Glenmark, which filed ANDA in October, last year, believes to have first-to-file status for Zetia and likely to entitled for 180-day market exclusivity period.
Thursday, March 29, 2007
Tuesday, March 27, 2007
Merck KGaA’s Dey unit has filed a patent infringement lawsuit against Sepracor Inc. in the U.S. District Court for the District of New York to prevent commercial launch of Brovana used for the treatment of chronic bronchitis and emphysema. Dey alleged that the Sepracor’s Brovana infringes its patent for a spray to open bronchial passage. Arformoterol tartrate, the active ingredient of Brovana is exemplified in the US 3,994,974 (the ‘974 patent). Brovana which got US FDA approval last year in October has currently four Orange Book listed patents covering formulations and method-of-use of arformoterol tartrate.
Monday, March 26, 2007
Saturday, March 24, 2007
Friday, March 23, 2007
Barr Pharmaceuticals has made a Para IV challenged against Japanese drugmaker Otsuka Pharmaceutical over atypical antipsychotic drug Abilify, generically known as Aripiprazole worth US $ 1.9 billion annual sales (based on IMS sales data ending January 2007). In response to Barr Para IV challenge, Otsuka has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey. Abilify is used in the treatment of schizophrenia and the manic and mixed episodes associated with bipolar disorder and currently been licensed to Bristol-Myers Squibb Co. which got US approval in 2002. Para IV certification would likely give Barr 180 days of exclusive marketing rights.
Thursday, March 22, 2007
Friday, March 16, 2007
Ranbaxy has yet again made Pfizer to defend their patents for blockbuster drug products now adding anti-cholesterol drug Caduet in their ongoing list of patent litigations. Pfizer filed a patent infringement suit against Ranbaxy in response to Ranbaxy’s ANDA submission with the US FDA for marketing approval of generic Caduet before expiry of Orange Book listed patents. Caduet is combination of amlodipine besylate and atorvastatin calcium. In its complaint, Pfizer alleged that Ranbaxy’s ANDA products would infringe Pfizer’s patents for Caduet. However, Ranbaxy is believed to have first-to-file status for Caduet.
Caraco Pharmaceutical Laboratories has brought a lawsuit against Forest Laboratories and H. Lundbeck A/S for declaratory judgment of patent non-infringement regarding the U.S. 6,916,941 (the ‘941 patent) which claims crystalline particles of escitalopram oxalate. The lawsuit is result of Caraco’s submission of an abbreviated new drug application (ANDA) to the US FDA seeking marketing approval for generic Lexapro, generically known as escitalopram oxalate before expiry of Orange book listed patents. Earlier on July 10, 2006 Forest and Lundbeck collectively filed a patent infringement lawsuit against Caraco, following Caraco’s ANDA submission along with Para IV certification with respect to the U.S. RE 34, 712 (the ‘712 patent) and ‘941 patent, alleging that Caraco’s ANDA products will infringe the ‘712 patent. However, Forest do not sued Caraco for infringement of the ‘941 patent.