The Indian arm of multinational drug-maker Mylan NV has launched its generic version of Hepatitic C drug sofosbuvir in the country, under the brand name MyHep, the company said, without divulging its price.

The once-a-day pill, originally from Gilead Sciences, has been in the eye of a storm in India and overseas over its pricing.

And Mylan’s launch will further stir the pot of generic competition on the drug.

Gilead’s sofosbuvir is priced at $84,000 for 12 weeks and its representatives have in the past told BusinessLine that the drug would be pegged in India at about $900 for the same period. Gilead’s patent application in India on the drug is also in a critical position, with one application being already rejected, even as another is pending at the Kolkata Patent Office.

Meanwhile, Gilead had entered into tie-ups with a clutch of local drug companies, allowing them to make their versions of the drug at reduced prices and market them in India and a list of other countries.

Local generic makers, including Cipla, Natco, Zydus Cadila and Hetero, have launched or are in the process of launching their products in India. The prices average between ₹11,000 and ₹12,000 for a month, a health-worker said, adding Mylan’s product is possibly pegged at a similar price. Mylan was not reachable for comment. The sofosbuvir launch in India comes even as Mylan faces a $40-billion global bid from its generic rival, Israeli drug company Teva.

Local tie-up Mylan was part of the local licensing tie-ups Gilead had entered into for technology transfer, in September last year.

Mylan, along with several other companies, were given non-exclusive rights to manufacture and distribute generic Sofosbuvir in 91 developing countries, including India.

Leena Menghaney, with international humanitarian organisation Médecins Sans Frontières (Doctors Without Borders), said prices on the drug are expected to come down in a year to $150 for three months and $300 for six months.

There is much apprehension, though, on the patent application that remains as there is much lobbying for the drug, and pressure being exercised, she added.

The real relief for patients will be when another critical drug, like Bristol-Myers Squibb’s new class of Hepatitis drugs daclatasvir, is also brought down to an affordable level, she added.

Chronic Hepatitis C is a blood-borne infectious disease, and the condition affects more than 100 million people in the developing world, including around 12 million people who are chronically infected with hepatitis C in India, Mylan said.

jyothi.datta@thehindu.co.in

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