Par Pharmaceutical Companies, Inc. announced that it began shipping all strengths of amlodipine besylate and benazepril hydrochloride capsules, the generic version of Novartis' Lotrel. Par has been awarded 180 days of marketing exclusivity for the 5/320mg and 10/320mg strengths, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product.
According to IMS Health data, annual sales in the U.S. for these two strengths of Lotrel are approximately $361 million.
Amlodipine besylate and benazepril hydrochloride capsules are a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and benazepril, an angiotension converting enzyme (ACE) inhibitor. Amlodipine besylate and benazepril hydrochloride tablets are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Amlodipine besylate and benazepril hydrochloride capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine.
When pregnancy is detected, amlodipine besylate and benazepril hydrochloride capsules should be discontinued as soon as possible. Drugs that act directly on the rennin-angiotension system can cause injury and death to the developing fetus.
Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.