US Pharm. 2011;36(2):XX.
Par Pharmaceutical Companies, Inc., announced that it began shipping all strengths of amlodipine besylate and benazepril hydrochloride capsules, the generic version of Lotrel (Novartis). Par has been awarded 180 days of marketing exclusivity for the 5/320-mg and 10/320-mg strengths, beginning 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, and benazepril, an ACE inhibitor. Amlodipine besylate and benazepril hydrochloride tablets are indicated for treating patients with hypertension who are not adequately controlled on monotherapy with either agent.