When does biktarvy patent expire?

What does the patent expiration mean for Biktarvy?

Biktarvy is a combination antiretroviral medication used to treat HIV-1 infection. The generic name of the product is bictegravir/emtricitabine/tenofovir alafenamide. The medication is developed by Gilead Sciences and has a complex patent landscape.

When does the Biktarvy patent expire?

The patent for Biktarvy was filed by Gilead Sciences in 2013 [1]. The patent protection is based on several patents, including patent EP2924343, which was granted in 2016 [2]. According to the data provided by DrugPatentWatch.com, the patent for Biktarvy is expected to expire in 2034 [3].

How does this impact the availability of generic versions?

Even though the patent is expected to expire in 2034, generic versions may become available earlier due to the Hatch-Waxman Act, which allows companies to apply for FDA approval of generic versions of a drug 5 years after market approval. Since Biktarvy was approved by the FDA in 2018, generic applications may be submitted in 2023.

Can biosimilars enter the market before patent expiry?

Biosimilars can enter the market before the patent expiry, but they are not the same as generics. Biosimilars are similar to branded products and require a separate approval from the FDA. In the case of Biktarvy, it's possible that biosimilar versions may be approved and marketed before the patent expiry.

What about the patent for individual components?

While the patent for Biktarvy has several components, the patent for individual components may have different expiration dates. For example, the patent for tenofovir alafenamide, one of the components of Biktarvy, was filed by Gilead Sciences in 2012 [4]. This patent is also expected to expire in 2034, but it's possible that generic versions of individual components may become available earlier.

What to expect after patent expiry?

After the patent expiry, generic versions or biosimilars of Biktarvy are expected to enter the market, which may lead to a decrease in prices and increased competition. This can benefit patients by providing more affordable treatment options and increasing access to HIV treatments.

Sources:

[1] Gilead Sciences. (2013). Bictegravir/emtricitabine/tenofovir alafenamide Patent Application.

[2] European Patent Office. (2016). Patent EP2924343.

[3] DrugPatentWatch.com. (n.d.). Biktarvy (Bictegravir/emtricitabine/tenofovir alafenamide) [online].

[4] Gilead Sciences. (2012). Tenofovir alafenamide Patent Application.