Japanese pharma giant Daiichi Sankyo has sued Matrix (Mylan) for patent infringement on blood pressure drug Azor.
Azor is the brand name of an oral antihypertensive medication which combines two antihypertensive agents in a film-coated tablet. It contains Amlodipine Besylate, a calcium channel blocker, and Olmesartan Medoxomil, an angiotensin-2 receptor antagonist (ARB or A2A). The patent is held by Daiichi Sankyo Pharmaceuticals. It is promoted in the U.S. by both Daiichi Sankyo and Forest Pharmaceuticals.Azor is available in different dose preparations: 5mg/20mg, 10mg/20mg,5mg/40mg and 10/40mg's of amlodipine and olmesartan respectively.
Mylan said Daiichi Sankyo filed the suit in a New Jersey federal court Tuesday against its India-based unit Matrix Laboratories Ltd., citing Matrix's application earlier this year with the Food and Drug Administration to sell a generic version of Azor. Following patent is listed for Azor in Orange Book
US5616599 (Expiry: Apr 25, 2016): The patent covers Olmesartan Medoxomil as product
Matrix is the first company to file an application with a Paragraph IV certification. Azor, which was approved on Sep 26, 2007, had sales of $22 million for its fiscal 2007 ended March 31, 2008. Azor has got new combination exclusivity, which will expire, on Sep 26, 2010.
Mylan is already in litigation on the same patent (‘599) for Benicar®(Olmesartan) and Benicar HCT®(Olmesartan/hctz) tablets in New Jersey District Court. Mylan is First para IV filer for Benicar and Benicar HCT.
Azor is the brand name of an oral antihypertensive medication which combines two antihypertensive agents in a film-coated tablet. It contains Amlodipine Besylate, a calcium channel blocker, and Olmesartan Medoxomil, an angiotensin-2 receptor antagonist (ARB or A2A). The patent is held by Daiichi Sankyo Pharmaceuticals. It is promoted in the U.S. by both Daiichi Sankyo and Forest Pharmaceuticals.Azor is available in different dose preparations: 5mg/20mg, 10mg/20mg,5mg/40mg and 10/40mg's of amlodipine and olmesartan respectively.
Mylan said Daiichi Sankyo filed the suit in a New Jersey federal court Tuesday against its India-based unit Matrix Laboratories Ltd., citing Matrix's application earlier this year with the Food and Drug Administration to sell a generic version of Azor. Following patent is listed for Azor in Orange Book
US5616599 (Expiry: Apr 25, 2016): The patent covers Olmesartan Medoxomil as product
Matrix is the first company to file an application with a Paragraph IV certification. Azor, which was approved on Sep 26, 2007, had sales of $22 million for its fiscal 2007 ended March 31, 2008. Azor has got new combination exclusivity, which will expire, on Sep 26, 2010.
Mylan is already in litigation on the same patent (‘599) for Benicar®(Olmesartan) and Benicar HCT®(Olmesartan/hctz) tablets in New Jersey District Court. Mylan is First para IV filer for Benicar and Benicar HCT.
Mylan has won FTF exclusivity for 3 products ( Olmesartan tablets, Olmesartan/hctz tablets and Olmesartan/Amlodipine tablets) by preparing invalidation ground against Olmesartan product patent
