Gilead’s Truvada will face generics competition in 2020

Generics/General | Posted 19/07/2019 post-comment0 Post your comment

Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.

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Truvada (emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) was approved in the US in 2012 as a pre-exposure prophylaxis (PrEP) for HIV prevention. Teva Pharmaceutical’s (Teva) generic version of Truvada was approved in 2017.

Truvada, which generated US$2.6 billion in revenue in the US in 2018, was expected to lose its patent protection in the US in 2021. However, in its most recent quarterly report to the US Securities and Exchange Commission, Gilead said that Teva would be able to launch its generic version of Truvada in September 2020 due to a legal decision regarding the company’s patents.

‘Pursuant to a settlement agreement relating to patents that protect Truvada and Atripla, Teva Pharmaceuticals will be able to launch generic fixed-dose combinations of emtricitabine, TDF and efavirenz in the United States on 30 September 2020’, Gilead said in its filing.

Not only will this put Truvada's US sales at risk earlier than expected, but Gilead will be under more pressure to accelerate take-up of its newer drug Descovy, which recently released positive data as a PrEP for HIV prevention.

This news comes as Gilead faces scrutiny over the legitimacy of its Truvada PrEP patent, with activists pointing out that the government funded early research on the drug’s use as a PrEP. However, Gilead claims that the revised generics launch date is unrelated to this case.

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