Venclexta expected to lose US exclusivity
Patent-expiry estimate. Compound patents listed with the FDA run to June 2031 and January 2032, with other patents to 2033. AbbVie books worldwide sales and shares US profit with Roche's Genentech.
When does Venclexta go off patent?
In the US, generics can launch from 2032. Venclexta is sold by AbbVie. Compound patents listed with the FDA run to June 2031 and January 2032, with other patents to 2033. AbbVie books worldwide sales and shares US profit with Roche's Genentech.
Venclexta's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
Filed with the FDA AbbVie and Genentech sued Dr. Reddy's and Alembic over generic filings in 2020 and settled in December 2024 on terms not made public.
| Company (product) | Stage |
|---|---|
| Dr. Reddy's | Filed; settled Dec 2024 |
| Alembic | Filed; settled Dec 2024 |
Checked October 2026. Sources: Bloomberg Law · AbbVie 10-Q, Q3 2023 (litigation)
Patent-expiry estimate. Compound patents listed with the FDA run to June 2031 and January 2032, with other patents to 2033. AbbVie books worldwide sales and shares US profit with Roche's Genentech.
Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →
Venclexta is 4.6% of AbbVie's 2025 revenue ($2.8B of $61.2B). With Vraylar, Imbruvica, Skyrizi and Rinvoq, the drugs tracked here add up to 57% of AbbVie's revenue losing US exclusivity by 2037.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Venclexta is highlighted.