Sun Pharma has commercially launched generic Amifostine for injection 500mg, which is therapeutically equivalent to MedImmune's Ethyol. Sun Pharma's product is being sold in the USA by its marketing partner Caraco Pharma. Sun Pharma had received a USFDA approval for Amifostine in March 2008. Ethyol has annual sales of approximately USD 80 million in the US. Sun Pharma, being the first-to-file an ANDA for generic Ethyol with a para IV certification, has a 180-day marketing exclusivity. The ANDA was filed with para IV certification against following Orange book listed patents
US5424471 (Expiry: 7/31/12)
US5591731 (Expiry: 7/31/12)
US5994409 (Expiry: 12/08/17) Medimmune filed a suit in the District Court of Maryland and the case is under litigation. earlier in january 2007 district court has delivered summary judgement opinion in this case.
Tuesday, 1 April 2008
Sun Pharma launches generic Amifostine for injection 500mg
Posted by ADKS at 3:11 pm