Sun Pharmaceutical Industries Ltd on March 31, 2008, has announced that it has commercially launched generic Amifostine for Injection 500mg, which is therapeutically equivalent to Medlmmune’s Ethyol?. The Company’s product is being sold in the United States by its marketing partner Caraco Pharmaceutical Laboratories. The Company had received a USFDA approval for this earlier in March 2008. Ethyoi? has annual sales of approximately USD 80 million in the US.

The Company being the first-to-file an ANDA for generic Ethyol? with a pare IV certification, has a 180-day marketing exclusivity.

Ethyol? is covered under 3 patents - ‘471 (July 31, 2012), ‘731 (July 31, 2012) and ‘409 (December 08, 2017). This ANDA was filed with para IV certification against all the patents Medimmune flied a suit in the District Court of Maryland and the case is under litigation.