When does Invega Sustenna go off patent?
In the US, generics can launch from 2031. Invega Sustenna is sold by Johnson & Johnson. The one listed US patent, a dosing patent, runs to January 2031 and was upheld at trial against Tolmar; J&J has since won or settled against every challenger. Sales include the longer-acting Invega Trinza and the ex-US brands Xeplion and Trevicta.
Invega Sustenna'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 Several generic makers filed to copy the injection. J&J won at trial against Tolmar, took judgments against Accord and Qilu, and settled with Sun and Tolmar.
| Company (product) | Stage |
|---|---|
| Tolmar | Filed; consent judgment May 2026 |
| Sun Pharma | Filed; settled Dec 2025 |
| Accord | Filed; judgment for J&J Nov 2025 |
| Qilu | Filed; judgment for J&J Nov 2025 |
Checked October 2026. Sources: J&J 10-K 2025 · Law360: J&J, Tolmar settle
Patent-expiry estimate. The one listed US patent, a dosing patent, runs to January 2031 and was upheld at trial against Tolmar; J&J has since won or settled against every challenger. Sales include the longer-acting Invega Trinza and the ex-US brands Xeplion and Trevicta.
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 →
Invega Sustenna is 4% of Johnson & Johnson's 2025 revenue ($3.8B of $94.2B). With Stelara, Xarelto, Simponi, Opsumit, Darzalex, Tremfya, Imbruvica and Erleada, the drugs tracked here add up to 46% of Johnson & Johnson's revenue losing US exclusivity by 2033. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Invega Sustenna is highlighted.