Natco to sell generic hepatitis C drug at Rs710 per tablet

Natco Pharma Limited has received approval from the Drugs Controller General (India) for manufacture and sale of generic sofosbuvir tablets (400mg), making it the first company in India to get approval for generic Sofosbuvir, a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences Inc under its brand Sovaldi.

Natco will market generic sofosbuvir under its brand `Hepcinat' and through strategic partners in India. Natco plans to price its generic medicine at a maximum retail price (MRP) of Rs19,900 for a bottle of 28 tablets and expects to launch in India very soon.

Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.

The approval for the hepatitis C drug, which came a day after the US Supreme Court's decision to deny certiorari for the generic version of Tamiflu oral capsules (oseltamivir phosphate), pushed up Natco shares.

Natco has partnered with Alvogen in the US to market Tamiflu. The denial was issued on 9 March, in the case of Gilead Sciences, Inc et al vs Natco Pharma Limited et al, Natco said in a release.

Natco has already received a tentative approval on 14 March 2014, for Oseltamivir Phosphate Capsules USP,30 mg (base), 45 mg (base) and 75 mg (base) on the abbreviated new drug application (ANDA) containing a paragraph IV certification filed with the United States Food & Drug Administration (USFDA).

Shares of Natco Pharma Limited (NPL) vaulted by nearly 10 per cent to a new yearly high today after the company announced that it had secured the approval from Drugs Controller General (India) for generic sofosbuvir tablets prescribed in the treatment of chronic hepatitis C infection.