Legal Decision Could Open the Doors for Truvada Generic Competition One Year Early, Gilead Says

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Gilead Sciences could see its dominance in the HIV market begin to wane as generic competition for Truvada, one of its vaunted therapeutics, hit the market – sooner than initially expected.

Truvada, which generated $3 billion in revenue last year, is expected to lose patent protection in 2021. In the United States, Truvada generated $2.6 billion. However, one of the anticipated generics for the HIV treatment could launch a year earlier. This morning, Pharmaphorum first reported that Teva Pharmaceuticals could begin to sell its triple-combination therapy in the U.S. next year. Gilead noted the potential rival drug in a filing with the U.S. Securities and Exchange Commission, according to the report.

In the filing, Gilead said that Teva would be able to begin selling its product in the United States due to a legal decision regarding the company’s patents for Truvada.

“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 Sept. 30, 2020,” Gilead said in its filing.

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The HIV market is expected to grow to $22.5 billion by 2025. With Truvada, Atripla and Stribild, Gilead Sciences has three of the top four best-selling HIV drugs on the market. Last year, Gilead also saw approval of Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1. The drug is largely expected to hit blockbuster status, despite a boxed warning that use of the medication could exacerbate hepatitis B.

Gilead is not the only player in the HIV market. In addition to Teva’s generic, Gilead also must contend with medications developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline. Last month, ViiV Healthcare submitted a New Drug Application to the US Food and Drug Administration for potential approval of its investigational combination treatment for HIV-1. ViiV is aiming for approval of its monthly injectable combination of ViiV’s cabotegravir and Janssen’s rilpivirine (Edurant) as a treatment of HIV-1 in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. Submission of the NDA came less than a month after ViiV snagged regulatory approval of Davato.

Even in the face of challenges, Gilead is continuing to focus on its HIV pipeline. In the most recent quarterly report, Gilead noted that HIV drugs were the primary driver of the $5.3 billion in quarterly revenues the company posted. Gilead’s HIV drugs generated $3.6 billion in the first revenue and more could be coming in the future. In October, Gilead announced 96-week results from a Phase III study of its HIV drug Biktarvy for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing Phase III study, Gilead said Biktarvy was found to be statistically non-inferior to a triple-combination regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) through 96 weeks of therapy.

Last week, Gilead also received kudos from the White House and the Department of Health and Human Services for its decision to donate 2.4 million annual doses of Truvada for PrEP to the U.S. Centers for Disease Control and Prevention (CDC) to provide treatment for uninsured Americans. PrEP, which has a list price of $20,000, is used to reduce the risk of HIV infection in individuals who are at higher risk for HIV. It has been shown to reduce the risk of new infection by up to 97 percent when taken consistently.

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