In a landmark decision, Hyderabad-based NATCO Pharma has been granted compulsory license for Sorafenib Tosylate sold under the brand name of Nexavar owned by Bayer.

Nexavar is the first-line treatment for liver and kidney cancer. Hyderabad-based Natco had filed an application for issue of compulsory license to manufacture a low-cost version of Nexavar.

Compulsory license allows a generic drug maker to manufacture and sell a copy of the innovator's drug on paying a royalty.

The compulsory license will enable NATCO to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets (one month's therapy) against Rs 2.84 lakh for a month's dosage, which is the cost of Naxavar sold by Bayer. The license is valid till the expiry of the patent, which is in 2021.

The license was granted by the Indian Patent Office under the provisions of Section 84 of the Indian Patents Act, 1970.

The order is subject to certain conditions, such as maintaining account of sales and payment of royalty to Bayer at six percent of the net sales on a quarterly basis. The order also makes it obligatory for NATCO to supply the drug free-of-cost to at least 600 needy and deserving patients per year.

NATCO welcomed this order and said this opened up a new avenue for availability of life-saving drugs at an affordable price to the suffering masses in India.

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