Sun Pharma gets USFDA approval to market generic Ethyol

MUMBAI: Sun Pharmaceutical Industries has received approval from USFDA for abbreviated new drug application of amifostine for injection 500mg. This generic amifostine for injection is therapeutically equivalent to Medimmune's Ethyol amifostine for injection 500mg. Ethyol has annual sales of $80 million in US.

Sun Pharma, being the first to file an ANDA for generic Ethyol, has a 180-day marketing exclusivity. Ethyol is covered under 3 patents - '471 (July 31, 2012), '731 (July 31, 2012) and '409 (Dec 08, 2017). Medimmune filed a suit in the district court of Maryland and the case is under litigation.

Amifostine is used as an adjuvant in cancer treatment. Sun Pharma's amifostine for injection will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of cisplatin.