FDA Approves Generic Version of Truvada

The cost of PrEP may be going down.

The Food and Drug Administration has approved a generic version of Truvada, the only drug OK'd so far for use as pre-exposure prophylaxis, aimed at preventing HIV-negative people from becoming infected with the virus. Truvada, also used in HIV treatment in combination with other medications, is a mix of emtricitabine and tenofovir disoproxil fumarate.

The FDA approved the generic version Thursday, according to the agency's website. The generic is made by Teva Pharmaceutical Industries of North Wales, Pa. Brand-name Truvada is a product of Gilead Sciences of Foster City, Calif.

Generic drugs are generally far cheaper than brand-name ones. The price is about $1,500 a month, or $18,000 a year, for the one-pill-daily dose of Truvada, as prescribed for PrEP, Medscape reports, with insurers and patient assistance programs covering much of the cost. The price of the generic hasn't been announced, but Mitchell Warren, executive director of HIV prevention organization AVAC, told Medscape that a generic drug will likely reduce the cost of PrEP by 80 percent. Generic versions of Truvada sold overseas have a price tag as low as $70 a year, he told the site.

However, just when the generic will be available isn't certain. Teva did not immediately respond to a request for information, and Gilead issued a statement to Poz asserting that the generic won't be on the market right away because it still holds patents on Truvada's components. But FDA official Jeffrey Murray told Poz the generic drug "will now be available in the U.S."

Tim Horn of Treatment Action Group told Poz, "Approval of a generic product doesn't necessarily mean that product launch is imminent. ... It's not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date. Regardless, now is the time to start thinking seriously about the advantages as well as the drawbacks of generic products to prevent and treat HIV."

In any case, the approval is welcome news, Warren told Medscape. "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." He said he expects other companies to launch generic versions of Truvada as well.

Activists expressed hope that Teva will offer patient assistance programs for the generic, as Gilead does with Truvada. "Gilead's patient and co-pay assistance programs have become central pillars in patient access," veteran activist Peter Staley told Poz. "They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version."