Breckenridge Pharmaceutical, Inc. announced today that it has finalized its agreement with Zhejiang Huahai Pharmaceuticals Co., Ltd. (Huahai) to market Nevirapine Tablets. Nevirapine 200mg Tablets are AB rated to Viramune® a non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV-1 infection and AIDS, which is marketed by Boehringer Ingelheim. The current market is in excess of $100 million according to industry data.
Huahai received tentative approval for Nevirapine Tablets by the United States Food and Drug Administration (FDA) 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 U.S. Patent expires on May 22, 2012. Through an exclusive marketing and distribution agreement, Huahai and Breckenridge Pharmaceutical will launch the Product in the U.S. upon patent expiration.
The PEPFAR initiative encourages sponsors anywhere in the world to submit U.S. marketing applications for single entity, fixed dose combination and co-packaged versions of previously-approved antiretroviral therapies- even if those products are still subject to patent or exclusivity market protection in the U.S. "Tentative" approval means the product satisfies all safety, efficacy, and manufacturing quality standards for marketing in the U.S., but cannot be marketed due to patent or marketing protection still in effect at that time. PEPFAR permits the sale and purchase of any such product that has either a "full" or "tentative" FDA approval. Since the products under PEPFAR are reviewed under the same standards for US approval, they are the same as those which would be approved in the United States.
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