Gilead licenses tenofovir to Indian generic manufacturers

On 22 September 2006, Gilead Sciences announced that it had signed new non-exclusive agreements with generic manufacturers in India, to produce and distribute generic versions of tenofovir disoproxil fumarate (tenofovir DF) to 95 low-income countries around the world, including India.

Affordable tenofovir is one on the treatment most in demand both for second-line therapy, and more tolerable first-line treatment.

The generic companies are Alkem Laboratories, Aurobindo Pharma, J.B. Chemicals & Pharmaceuticals, Matrix Laboratories, Medchem International, Ranbaxy Laboratories and Shasun Chemicals & Drugs. In August, Gilead announced similar agreements with India-based Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab.

The license agreements require that the generic companies meet certain national and international regulatory standards and include a technology transfer to enable expeditious production of large volumes of high-quality generic versions of tenofovir DF. In addition, these agreements allow the manufacture of commercial quantities of both active pharmaceutical ingredient (API) and finished product.