First Generic Atripla Approved for Developing Nations

The first generic version of the fixed-dose combination tablet Atripla (tenofovir, emtricitabine and efavirenz) has been granted tentative approval by the Food and Drug Administration for use in resource-poor countries where the President’s Emergency Plan for AIDS Relief (PEPFAR) is scaling up access to antiretroviral (ARV) therapy.

Tentative approval means that the generic tablet is chemically equivalent with the safe and effective brand-name version and that its developer, Matrix Laboratories Limited of Hyderabad, India, has good standards in manufacturing. Tentative approval is granted in order for a generic drug to be sold to programs participating in PEPFAR; it will not be sold in the United States or most other industrialized nations.

This is because the patents that protect brand-name Atripla will not expire before 2017 and are still held in countries not included in the PEPFAR program.Though generic versions of other HIV drugs have been granted tentative approval by the FDA, this is the first version of Atripla—a preferred treatment combination recommended by the U.S. Department of Health and Human Services—to be given the green light. The new generic will likely expand treatment choices for people in developing countries, where options are often limited.