Natco Pharma, a Rs. 650 crore Hyderabad based pharma company, has received the United States Food & Drug Administration (US FDA) tentative approval for oseltamivir phosphate capsules USP, 30 mg (base), 45mg (base) and 75 mg (base). Natco has tied up with Alvogen for marketing this product.
Natco may have first to file approval status for the Abbreviated New Drug Application (ANDA), contingent upon successful litigation outcome of original drug patent 5,763,483 (the '483 patent). According to IMS Health, Tamiflu (Roche's trade name for oseltamivir phosphate) had US sales of approximately $495 million for twelve months ending September 2013.