Sun Pharma launches generic Amifostine injection

Sun Pharmaceutical Industries 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 (Jul. 31, 2012), 731 (Jul. 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.

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