FDA Approves First Generic Truvada in US

June 09, 2017

UPDATED June 9, 2017 // The US Food and Drug Administration (FDA) has approved the first generic version of emtricitabine/tenofovir disoproxil (Truvada, Gilead Sciences) to both treat and prevent HIV infections in this country, the agency announced today.

The manufacturer of the generic is Teva Pharmaceutical Industries. However, the leader of an HIV prevention organization told Medscape Medical News that more generic drug makers are likely to introduce their versions of emtricitabine/tenofovir disoproxil.

Generic versions of the drug are already marketed in other nations. In 2013, the FDA approved a generic form of emtricitabine/tenofovir disoproxil made by Strides Arcolab Limited in India for use outside the United States under a White House AIDS relief program. The generic was not made available in the United States because the drug was under patent protection.

The specific indication for emtricitabine/tenofovir disoproxil in the United States is for the treatment of HIV-1 in combination with other antiretroviral agents and for preexposure prophylaxis (PrEP) in conjunction with safer sex practices to prevent sexually acquired HIV infections in high-risk adults. Although the FDA has approved some 40 drugs to treat HIV infections, emtricitabine/tenofovir disoproxil is the only one approved for PrEP.

The list price for Gilead Science's Truvada is roughly $1500 for a month's regimen of one pill per day, or about $18,000 a year, although health insurance and patient-assistance programs knock down the price considerably. Generic versions of Truvada in other countries cost as little as $70 a year, according to Mitchell Warren, executive director of AVAC, an international organization that promotes HIV prevention.

In an interview with Medscape Medical News, Warren said that the debut of a generic version of emtricitabine/tenofovir disoproxil in this country will lower the price barrier to PrEP.

"This is an exciting day," he said. "We've seen momentum for PrEP programs and policies. Having a lower cost alternative will only increase that momentum."

Warren estimates that Teva Pharmaceutical's generic version of Truvada could reduce the cost of PrEP by as much as 80%. He said he hopes that the drug maker will follow in Gilead Science's footsteps and create a patient-assistance program for those in financial need.

Teva Pharmaceutical did not respond to a request for an interview.

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