When does Opsumit go off patent?
It already has: US generics have been on sale since 2026. Opsumit is sold by Johnson & Johnson. US generics entered late in Q2 2026, J&J says. Pulmonary arterial hypertension. Sales include Opsynvi, which combines macitentan with tadalafil.
Opsumit's US exclusivity date is based on generics launched. US generics have already launched, so the loss of exclusivity is under way. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
Copies on the US market Generic macitentan launched from May 2026. About a dozen makers hold FDA approval, and Teva, Alembic, Sun, Torrent and others are selling.
| Company (product) | Stage |
|---|---|
| Teva | Launched June 2026 |
| Alembic | Launched June 2026 |
| Sun Pharma | Launched June 2026 |
| Torrent | Launched June 2026 |
From the FDA's own approval lists; FDA approval does not always mean a product has launched. Checked October 2026. Sources: J&J 10-Q, Q2 2026 · Teva 10-Q, Q2 2026 · Drug Store News · Drugs.com: generic Opsumit
In Q2 2026, US sales were $416M, 96% of the $433M in Q1 2026, the last full quarter before copies. See the launch tracker →
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 →
Opsumit is 2.5% of Johnson & Johnson's 2025 revenue ($2.3B of $94.2B). With Stelara, Xarelto, Simponi, Darzalex, Tremfya, Invega Sustenna, 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. Opsumit is highlighted.