Sun Pharma. announced that USFDA has granted final approval to market a generic version of MedImmune’s Ethyol®, Amifostine for injection 500mg. This generic amifostine for injection is therapeutically equivalent to MedImmune’s Ethyol® Amifostine for injection 500mg. S-2-(3-Aminopropylamino) ethyl dihydrogen phosphorothioate (Amifostine) 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 –
US5424471 (Expiry: July 31, 2012)-Covers crystalline Amifostine composition
US5591731 (Expiry: July 31, 2012)- Covers crystalline Amifostine composition with improved stability
US5994409 (Expiry: Dec 8, 2017)- Method of use
US5424471 (Expiry: July 31, 2012)-Covers crystalline Amifostine composition
US5591731 (Expiry: July 31, 2012)- Covers crystalline Amifostine composition with improved stability
US5994409 (Expiry: Dec 8, 2017)- Method of use
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. 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.
