Sun Pharmaceutical Industries Ltd. 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 United States by its marketing partner Caraco Pharmaceutical Laboratories. Sun Pharma had received a US FDA approval for this earlier 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 all three patents Ethyol is covered under - '471 (July 31, 2012), '731 (July 31, 2012) and '409 (Dec 8, 2017). Medimmune filed a suit in the District Court of Maryland and the case is under litigation.