Sun Pharmaceutical Industries Ltd. announced today that it 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 USFDA approval for this earlier in Mar 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.
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.
Sourced From: Sun Pharmaceutical Industries Ltd
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