Sun Pharmaceutical Industries Ltd. said the US FDA has granted approval for its Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune's Ethyol, amifostine for injection 500mg.
This generic amifostine for injection, used as an adjuvant in cancer treatment, is therapeutically equivalent to MedImmune's Ethyol amifostine for injection 500mg. 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.
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.
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