Hetero, Natco get DCGI nod for Hepatitis C drug Sofosbuvir

Hyderbad-based Hetero and Natco companies on Thursday announced that they have received approval for generic Sofosbuvir tablets, 400 mg, from the Drug Controller General of India.

Hetero will launch Sofosbuvir under its brand Sofovir in India. Hetero will price the generic medicine at Rs. 19,900 for a bottle of 28 tablets and will launch the medicine this month in India and other countries soon.

Natco will market generic sofosbuvir under its brand Hepcinat and through strategic partners in India. Sofosbuvir 400 mg tablets, a once-daily oral dose is being used for the treatment of Hepatitis C infection across the world.

Hetero has a non-exclusive License Agreement with Gilead Sciences, Ireland to manufacture and sell generic versions of its chronic Hepatitis C medicines in 91 developing countries.

Gilead Sciences has out-licensed it to at least eight Indian pharma major including Ranbaxy, Cadila, Mylan, Hetero, Cipla, Biocon, Natco, Strides Arcolab.

The cost of treatment in the US is roughly $84,000 for a three-month course. The comparative cost in India with the drug priced by Hetero at Rs. 19,990 per bottle (28 tabs) will be approximately Rs. 60,000.

In India, the incidence of the Hepatitis C problem is around two per cent of the population.

Hetero said the infrastructure and manufacturing facilities are in place to meet the demands of the drug in the near future.

It will focus on developing countries, especially Egypt where the incidence is very high. Hetero already has a subsidiary there.