Breckenridge in generic Viramune deal with Zhejiang Huahai Pharma

Privately-held US generic drugmaker Breckenridge Pharmaceutical that it has finalized its agreement with China’s Zhejiang Huahai Pharmaceuticals to market nevirapine tablets 200mg, an AB rated product to Viramune, a non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV-1 infection and AIDS, which is marketed by independent German drug major Boehringer Ingelheim. The current market is in excess of $100 million according to industry data quoted by the US firm.

Huahai received tentative approval for nevirapine tablets from the US Food and Drug Administration on July 10, 2007, and has been distributing the product in Africa since that time under the PEPFAR plan (President's Emergency Plan for Aids Relief). The US Patent expires on May 22, 2012, says Breckenridge. Through an exclusive marketing and distribution agreement, Huahai and Breckenridge will launch the product in the US upon patent expiration.

Provisions of PEPFAR