USFDA approves Sun Pharmaceutical's generic cancer drug Ethyol in US markets
17 Mar 2008
The USFDA has granted approval for Sun Pharmaceutical Industries' abbreviated new drug application (ANDA) to market a generic version of Medimmune's Ethyol, amifostine injection in 500mg dosage.
This generic amifostine for injection is therapeutically equivalent to Medimmune's Ethyol amifostine injection in 500mg, which had annual sales of approximately $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 for the product, which is used as an adjuvant in cancer treatment.
Sun Pharma's amifostine injections will be indicated for the reduction of kidney damage in patients who have advanced ovarian cancer and are being given repeat doses of chemotherapy drug cisplatin.
Ethyol is covered under three patents - "471", and "731" expiring on July 31, 2012 and "409", which expires on 8 Dec 2017. sun Pahrmaceuticals had filed its ANDA with para IV certification against all the patents with Medimmune having filed a suit against the grant of patent to Sun in the District Court of Maryland. The case is currently under litigation.