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Gilead Licenses Generic Viread

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Gilead Sciences has signed non-exclusive license agreements to provide generic versions of tenofovir disoproxil fumarate (sold by Gilead under the brand name Viread) to three generic manufacturers in India. These license agreements grant to Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab the rights to produce and distribute generic versions of tenofovir to 95 low-income countries around the world, including India.

The license agreements require that the generic manufacturers meet certain regulatory standards and include a technology transfer to enable rapid production of large volumes of high-quality generic versions of tenofovir. These agreements also allow the manufacture of commercial quantities of both API and finished product. Gilead continues to pursue license agreements with additional Indian generic manufacturers.

“We are pleased to have finalized agreements with Emcure, Hetero, and Strides Arcolab and anticipate granting additional licenses over time to help meet the needs of patients in the developing world,” said John C. Martin, Ph.D., president and chief executive officer of Gilead Sciences. “We hope that competition among multiple manufacturers will result in even lower prices for Viread in the developing world than what Gilead is currently offering. Gilead is committed to and making every effort to increase access worldwide, particularly in resource-limited areas, where the epidemic has hit the hardest.”

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