2031, date not disclosed
Descovy expected to lose US exclusivity
Company guidance. Gilead 10-K: US patent expiry 2031 (Europe 2027). Gilead sued Cipla in February 2026 over a patent challenge. HIV treatment and prevention.
When does Descovy go off patent?
In the US, generics can launch from 2031. Descovy is sold by Gilead. Gilead 10-K: US patent expiry 2031 (Europe 2027). Gilead sued Cipla in February 2026 over a patent challenge. HIV treatment and prevention.
Descovy's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. 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 |
|---|---|---|
| US expiry, per Gilead | Latest compound patent, with the 2022 settlements | 2031 |
| TAF patents listed with the FDA | Tenofovir alafenamide, with pediatric exclusivity | 15 February 2033 |
| Later patents | Drug product and a use | 29 June 2036 |
| Europe | Compound patent, per Gilead | 2027 |
Gilead gives 2031 as Descovy's US patent expiry, and 2027 in Europe. The FDA lists the patents on its tenofovir alafenamide (TAF) component to August 2032, or February 2033 with pediatric exclusivity. In September 2022 Gilead settled with five generic makers (Lupin, Apotex, Macleods, Hetero and Cipla) on terms it has not disclosed, and the FDA has since approved several of their generics; none has launched. Gilead sued Cipla over a new challenge in February 2026.
Sources: Gilead 10-K 2025 · FDA Orange Book data files
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $1.70B | $1.40B | – |
| 2022 | $1.87B | $1.63B | +10% |
| 2023 | $1.99B | $1.77B | +6% |
| 2024 | $2.11B | $1.90B | +6% |
| 2025 | $2.76B | $2.56B | +31% |
Worldwide net sales as reported, with the US share. Sources: Gilead 10-K 2025 · Gilead 10-K 2023
Approved, waiting to launch The FDA has approved Descovy generics from Apotex and Lupin (2024), Macleods (April 2026) and Natco (August 2026). None has launched: five makers settled in 2022 on terms Gilead has not disclosed, and Gilead puts US exclusivity at 2031. Gilead sued Cipla over a new challenge in February 2026.
| Company (product) | Stage |
|---|---|
| Natco | FDA-approved 26 Aug 2026 |
| Macleods | FDA-approved 7 Apr 2026; settled 2022 |
| Lupin | FDA-approved 13 Dec 2024, not marketed; settled 2022 |
| Apotex | FDA-approved 17 May 2024, not marketed; settled 2022 |
| Hetero | Filed with the FDA; settled 2022 |
| Cipla | Filed with the FDA; in litigation, sued Feb 2026. Earlier case settled in 2022; new challenge |
Checked October 2026. Sources: FDA Orange Book: Natco · FDA Orange Book: Macleods · Gilead 10-K 2025
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 →
| Scenario | 2025 US sales | Year 1 (about 2032) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $2.56B | $0.00B0% | $0.00B0% | $0.02B1% |
| Median | $2.56B | $0.46B18% | $0.18B7% | $0.15B6% |
| Slowest past case | $2.56B | $1.23B48% | $0.63B25% | $0.44B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Descovy's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
Descovy is 9.4% of Gilead's 2025 revenue ($2.8B of $29.4B). With Biktarvy, 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. Descovy is highlighted.
Company guidance. Gilead 10-K: US patent expiry 2031 (Europe 2027). Gilead sued Cipla in February 2026 over a patent challenge. HIV treatment and prevention.
Natco joins Apotex, Lupin and Macleods with FDA approval; settlement terms are undisclosed and Gilead puts US exclusivity at 2031. FDA Orange Book