When does Biktarvy go off patent?
In the US, generics can launch from 2036. Biktarvy is sold by Gilead. Settlements bar US generics before 1 April 2036, later than the earlier 2033 estimate.
Biktarvy's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
| Patent or protection | Covers | Expiry |
|---|---|---|
| Settlements with Lupin, Cipla and Laurus | Full-dose Biktarvy tablets | 1 April 2036 |
| Same settlements | Lower-dose tablets for children | 19 November 2035 |
| Gilead estimate, Europe | Biktarvy in the EU | 2033 |
Gilead settled with the three generic makers that challenged Biktarvy's patents: none can sell a generic of the full-dose tablet in the US before 1 April 2036, more than two years later than Gilead's previous projection of December 2033. The lower-dose pediatric tablet can follow from 19 November 2035 if pediatric exclusivity is granted, or May 2035 if not. Medicare's negotiated price takes effect in 2028, eight years before generics.
Sources: Gilead 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $11.85B | $9.69B | – |
| 2024 | $13.42B | $10.86B | +13% |
| 2025 | $14.33B | $11.47B | +7% |
Worldwide net sales as reported, with the US share. Source: Gilead 10-K 2025
Filed with the FDA Gilead settled with all three generic filers in October 2025. No US generic is expected before 1 April 2036.
| Company (product) | Stage |
|---|---|
| Lupin | Filed with the FDA; settled Oct 2025; US entry allowed from 1 Apr 2036. Subject to standard acceleration provisions |
| Cipla | Filed with the FDA; settled Oct 2025; US entry allowed from 1 Apr 2036. Subject to standard acceleration provisions |
| Laurus Labs | Filed with the FDA; settled Oct 2025; US entry allowed from 1 Apr 2036. Subject to standard acceleration provisions |
Checked October 2026. Sources: Gilead 10-K 2025 · Fierce Pharma
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Biktarvy was selected for the Medicare Drug Price Negotiation Program. CMS must publish the negotiated prices for 2028 by 30 November 2026. That is 8 years before US generics can launch, so Medicare revenue comes under pressure first. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only. See every negotiated Medicare price →
Biktarvy is 49% of Gilead's 2025 revenue ($14.3B of $29.4B). With Descovy, the drugs tracked here add up to 58% of Gilead's revenue losing US exclusivity by 2036.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Biktarvy is highlighted.
Deadline for CMS to publish the negotiated prices for the drugs selected for 2028. The prices take effect on 1 January 2028. Xeljanz will have none, because CMS found a generic on sale.
Prices are due from CMS by 30 November 2026.
Gilead settled with all three generic filers in October 2025.
Settlements with Lupin, Cipla and Laurus Labs bar generics before 1 April 2036, more than two years after Gilead's previous December 2033 estimate. Fierce Pharma