When does Vraylar go off patent?
In the US, generics can launch from 2029. Vraylar is sold by AbbVie. The compound patent runs to June 2029 with pediatric exclusivity; a second compound and use patent runs to March 2030. Settlement terms with generic makers have not been disclosed.
Vraylar'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.
Patent-expiry estimate. The compound patent runs to June 2029 with pediatric exclusivity; a second compound and use patent runs to March 2030. Settlement terms with generic makers have not been disclosed.
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 →
Approved, waiting to launch The FDA has approved generic cariprazine from Sun, Zydus and Aurobindo, but none is marketed. AbbVie and Gedeon Richter sued them in 2019; any settlement terms are not public.
| Company (product) | Stage |
|---|---|
| Sun Pharma | FDA-approved 2022; not marketed |
| Zydus | FDA-approved 2022; not marketed |
| Aurobindo | FDA-approved Dec 2025; not marketed |
Checked October 2026. Sources: FDA Orange Book: Vraylar patents · AbbVie 10-Q, Q2 2020 (litigation)
Vraylar was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 44% below its list price. That is 2 years before US generics can launch, so Medicare revenue comes under pressure first. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number.
Vraylar is 5.9% of AbbVie's 2025 revenue ($3.6B of $61.2B). With Imbruvica, Venclexta, 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. Vraylar is highlighted.