Terbinafine: The Next Blockbuster to Go Off-patent

Terbinafine hydrochloride, the active ingredient of Novartis blockbuster antifungal drug Lamisil, will be running out patent protection on December 30, 2006 making USD 538 million (Source: Novartis Annual Report, 2005) US market vulnerable to generic players. Indian leading pharmaceutical company – Ranbaxy has already received tentative approval from the U.S. FDA to manufacture and market Terbinfaine hydrochloride tablets, 250mg. Apart from Ranbaxy, Mylan also received tentative approval for terbinafine hydrochloride tablets whereas Taro received tentative approval for Terbinafine hydrochloride cream, 1%. Earlier in 2004, Novartis successfully defended Para IV challenge against Indian generic company Dr. Reddy’s Laboratories (DRL) which withdrew its Para IV challenge after evaluating the critical time period required to obtain favorable Federal Circuit decision and subsequently amended its ANDA from Para IV certification to Para III certification. The infringement suit was filed in the U.S. District Court for the Southern District of New York by Novartis in response of DRL Para IV certification on the U.S. Patent # 4,755,534 (the ‘534 patent).