Natco to launch Hepatitis C drug in India soon

Natco Pharma plans to launch the generic version of Sovaldi, the blockbuster drug used to treat chronic Hepatitis C in India soon. Sovaldi is made by U.S. pharma major Gilead Sciences, and Natco recently entered into a non-exclusive licensing agreement with Gilead to make and sell generic versions of Sovaldi in 91 developing countries.

The company, on Monday, launched the generic version of Sovaldi in Nepal under the brand Hepcinat. The product is priced at Rs.19,900 per bottle of 28 tablets in Nepal, and covers the treatment duration of three months for a patient.

“We will be launching the drug in the next few weeks in India, and are awaiting approval from the Drugs Controller General of India (DCGI),” M. Adinarayana, Vice-President, Legal & Corporate Affairs, Natco Pharma, told this correspondent.

Gilead’s compound sofosbuvir is a breakthrough treatment for Hepatitis C, a disease affecting the liver. If untreated, it can cause liver cirrhosis or liver cancer and has a high mortality rate.

Sovaldi with a 90 per cent cure rate for Hepatitis C, was introduced in the U.S. in November 2013 priced at $84,000 per patient. In India Hepcinat will be priced as in Nepal, which is a fraction of the price Gilead prices it in developed markets. As per the agreement with Gilead, Natco will pay Gilead royalty at 7 per cent of billing price.

Generic Tamiflu patent

In an unrelated development, the U.S. Supreme Court declined a review of a federal circuit court which had ruled in favour of Natco Pharma in a patent infringement litigation over Tamiflu, a drug used to treat swine flu. Natco has partnered with Alvogen in the U.S. to market the product.

A statement from Natco said it was “pleased with the U.S. Supreme Court’s decision to deny certiorari for the generic version of Tamiflu oral capsules (oseltamivir phosphate).”

Natco had received a tentative approval on March 14, 2014, for Oseltamivir Phosphate Capsules USP, 30 mg, 45 mg and 75 mg on the Abbreviated New Drug Application containing a paragraph IV certification filed with the U.S. FDA.