Novartis now has two patent suits pending against generics maker Teva over the blockbuster hypertension drug Lotrel (Lotrel contains a combination of two active ingredients--amlodipine besylate and benazepril), lodging a new complaint after Teva submitted a bid to make its proposed generic in different dosage strengths (A mlodipine Besylate and Benazepril HCl) Capsules,2.5 mg base/10 mg,5 mg base/10 mg,5 mg base/20 mg,and 10 mg base/20 mg and new strengths 4/40 and 10/40mg
Novartis and Teva have been locked in litigation over Teva's ANDA for generic Lotrel since 2004. As the 30-month stay expired last year and, probably sensing that Teva was close to obtaining final approval (and fearing an at-risk launch), Novartis moved for a preliminary injunction in March.
On May 18, 2007, Teva received approval (after expiry of US4879303) and launched which was followed by a restraining order.
Teva is currently in patent litigation concerning this product in the U.S.District Court for the District of New Jersey. A suit was brought against Teva in September 2004 involving its paragraph IV certification to US6162802 (Expiry: 19-12-2017) which covers a method for the treatment of a variety of cardiovascular disorders and related conditions in a mammal having at least one such disorder or condition is disclosed comprising treating the mammal with cotherapy comprising benazepril and amlodipine or pharmaceutically acceptable salts of either or both. Combination formulations of benazepril and amlodipine for use in the method are also disclosed.
The following companies have also filed para IV against US6162802
Watson Laboratories
Dr. Reddy's Laboratories
Par Pharmaceuticals/Kali Labs
Lupin LtdMylan
Novartis and Teva have been locked in litigation over Teva's ANDA for generic Lotrel since 2004. As the 30-month stay expired last year and, probably sensing that Teva was close to obtaining final approval (and fearing an at-risk launch), Novartis moved for a preliminary injunction in March.
On May 18, 2007, Teva received approval (after expiry of US4879303) and launched which was followed by a restraining order.
Teva is currently in patent litigation concerning this product in the U.S.District Court for the District of New Jersey. A suit was brought against Teva in September 2004 involving its paragraph IV certification to US6162802 (Expiry: 19-12-2017) which covers a method for the treatment of a variety of cardiovascular disorders and related conditions in a mammal having at least one such disorder or condition is disclosed comprising treating the mammal with cotherapy comprising benazepril and amlodipine or pharmaceutically acceptable salts of either or both. Combination formulations of benazepril and amlodipine for use in the method are also disclosed.
The following companies have also filed para IV against US6162802
Watson Laboratories
Dr. Reddy's Laboratories
Par Pharmaceuticals/Kali Labs
Lupin LtdMylan
