First Truvada Anti-HIV Drug Generic Approved By FDA, But Will Not Be Immediately Available

Teva Pharmaceuticals’ generic version of Truvada anti-HIV drug (emtricitabine and tenofovir disoproxil fumarate) has been approved by the FDA on Friday, 9 June 2017.

Insiders from ’PrEP Facts: Rethinking HIV Prevention and Sex’ Facebook group shared Gilead’ response recently with permission to publish. As Gilead representative stated, despite an FDA approval for Teva to produce the drug, the Teva’s medicine won’t be available to commercialize it off-patent until 2021, when it’s component patents expire. There are still no alternative ways — Gilead has sued other generic drugmakers, including Cipla, Lupin, and Amneal Pharmaceuticals over their versions of Truvada.

Photo — Gilead representative statement shared with permission in ’PrEP Facts: Rethinking HIV Prevention and Sex’ Facebook group

A Teva representative declined to comment how much its version of the drug will cost or when it will be available to patients other than to say the company had received approval.

Truvada was initially approved by FDA in 2004 to treat HIV infection in combination with other antiretroviral medicines, and later expanded approval as the first drug for PrEP — pre-exposure prophylaxis among persons at substantial risk of exposure to HIV in 2012.

According to Gilead, around 125,000 people are taking Truvada in the US as of the first quarter of 2017. Despite the growing uptake of Truvada for PrEP in the US, only a small percentage of patients at risk for HIV infection are taking PrEP. Many have cited Truvada cost, which is around $1,500 a month in the US, as a barrier to access, although Gilead offers an assistance program for uninsured patients and a co-pay assistance program for Truvada.

“There are often ways to cover the cost of Truvada for PrEP ... but those can be kind of cumbersome, and I think in many situations if there was just a straight-forward way insurance provides it, I think that would increase access to PrEP,” Paul Volberding, director of the AIDS Research Institute at the University of California, San Francisco, told The Regulatory Affairs Professionals Society.

Volberding said he believes the cost for generic versions of Truvada will eventually reduce spending on PrEP significantly once there are several competitors on the market, — “You have to get competition within the generic companies,” he said, adding that increasing awareness about PrEP is still one of the biggest challenges.