Natco becomes the first Indian company to launch the drug after signing a voluntary licence with Gilead Sciences
Hyderabad-based Natco Pharma has launched the generic version of US company Gilead Sciences' sofosbuvir in Nepal, a week after signing a voluntary licence with the US drug maker. Natco becomes the first Indian company to launch the drug; more than six companies, including Gilead, are waiting to launch the drug in India.
Sofosbuvir is used to treat chronic hepatitis C infection and is sold globally by Gilead Sciences under the brand Sovaldi. The drug is being launched in Nepal under the brand name Hepcinat and is priced by Natco at US$302 (Rs 19,900) for a bottle of 28 tablets. Gilead had announced that it would charge $900 for a 12-week treatment in India. In the US, it has priced the drug at $84,000 for 12 weeks of treatment.
Patent applications on sofosbuvir were challenged in India by Natco Pharma, Initiative for Medicines, Access and Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014. In January 2015 the Indian Patent Controller rejected Gilead's key patent applications for sofosbuvir, giving Indian generic makers an opportunity to launch cheaper versions of the drug in India. Gilead had signed voluntary licence agreements with generic companies in India for manufacturing the oral drug, which first received regulatory approval in the US in November 2013.
'Natco hopes to launch Hepcinat in India soon, subject to approval from the Drugs Controller General of India (DCGI),' Natco said in its filing to the stock exchange. 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.
Besides Natco, Cipla has also said that it is almost ready to launch the drug under the brand name of Hepcvir. While Gilead and other drug makers are expected to launch the drug this year, the company is still waiting for a patent for the drug from the patent controller.