Analysts see threat to Novartis' Lotrel

Novartis may face a generic challenge to its fourth-largest drug in thewake of Dr Reddy's successful lawsuit with Pfizer over the calcium antagonist amlodipine (Marketletter December 23, 2002), according to analyst Denise Anderson at Julius Baer. The product, Lotrel, is a combination of Novartis' ACE inhibitor Cibacen/Lotensin (benazepril) and Pfizer's Norvasc (amlodipine besylate) and achieved sales of 761 million Swiss francs ($527 million), all in the USA, in the first nine months of 2002.

On December 16, a US court ruled that Dr Reddy's amlodipine maleate is not covered by a patent extension for Pfizer's amlodipine besylate, clearing the way for Dr Reddy's to launch its product in August. Dr Anderson notes that Cibacen/Lotensin is also expected to face US generic competition starting in the same month.

The ruling increases the likelihood that someone will challenge Lotrel's remaining patent, which expires in December 2017, as the other patents, set to expire in 2006 and 2007, cover the amlodipine part of Lotrel. "In the worst case, we believe a generic form of Lotrel is over three years from the market," she said, while adding that, even without generics, growth is expected to slow as payers encourage patients to take two cheaper generics rather than Lotrel.