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FDA Approves Generic Truvada

10 June 2017

The cost of PrEP may be going down. Gilead has sued other generic drugmakers, including Lupin and Cipla, and most recently Amneal Pharmaceuticals over their versions of Truvada.

The US Food and Drug Administration (FDA) has approved a generic form of the drug Truvada, an antiretroviral and pre-exposure prophylaxis (PrEP) from Gilead Sciences. Truvada, also used in HIV treatment in combination with other medications, is a mix of emtricitabine and tenofovir disoproxil fumarate. "The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs". Currently, the wholesale price for a month's worth of Truvada is $1415. The only difference between the generic and Truvada will be the cost and reportedly a variation on its famous powder-blue color.

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However, just when the generic will be available isn't certain. "Usually, it takes several generics before full cost-savings potential is reached though".

What remains unclear is what exclusivity the FDA is giving Teva to produce generic Truvada.

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ACT UP and Treatment Action Group veteran Peter Staley is concerned there will be a backlash of sorts.

In any case, the approval is welcome news, Warren told Medscape. "We've seen momentum for PrEP programs and policies". While Gilead offers an assistance program for uninsured patients and a co-pay assistance program for Truvada, many have cited its cost, which is around $1,500 a month in the U.S., as a barrier to access. "Having a lower-cost alternative will only increase that momentum". "They must maintain these programs, and Teva must establish equivalent or better assistance programs for their generic version".

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FDA Approves Generic Truvada