Sun Pharmaceutical Industries Ltd. has received USFDA approval for the Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune’s Ethyol®, amifostine for injection 500mg.
Sun Pharma, being the first-to-file an ANDA for generic Ethyol® with a para IV certification, has a 180-day marketing exclusivity. This generic amifostine for injection is therapeutically equivalent to MedImmune’s Ethyol® amifostine for injection 500mg. Ethyol® has annual sales of approximately USD 80 million in the US.
Ethyol® is covered under 3 patents – ‘471 (July 31, 2012), ‘731 (July 31, 2012) and ‘409 (Dec 8, 2017). This ANDA was filed with para IV certification against all the patents. Medimmune filed a suit in the District Court of Maryland and the case is under litigation.