The US FDA approved India based Natco Pharma and its US partner Alvogen’s application for a generic of Tamiflu in August.
Alvogen—a CMO with more than 350 generic products on the market—told Reuters it expected “the cheaper product to save the US healthcare system over $500M in the upcoming flu season.”
Tamiflu has previously faced criticism after a 2014 Cochrane review reported little evidence of the drug’s efficacy in reducing viral spread, the number of complications and hospitalisations of patients with influenza.
Oseltamivir phosphate is an oral neuraminidase inhibitor invented by Gilead Science Inc., licensed out to Roche as Tamiflu in 1996.
In 2011, Natco first challenged Gilead’s patent of Tamiflu, over claims it was invalid. A settlement was made last December, with Natco proceeding to go ahead with development of its 30mg, 50mg and 75mg of oseltamivir phosphate capsules.
But Natco and Alvogen are not alone in their pursuit of a Tamiflu generic.
Cipla Ltd. marketed Antiflu back in 2011, which contains the same API as Tamiflu—oseltamivir phosphate—in a capsule and syrup formulation.
Roche granted Hetero Drugs in India a sublicense to manufacture oseltamivir in 2006.
Natco and Alvogen did not respond to requests for further information.