When does Xarelto go off patent?
It already has: US generics have been on sale since 2025. Xarelto is sold by Bayer and Johnson & Johnson. The first US generic launched in March 2025. Sales: J&J in the US ($2.63B) plus Bayer elsewhere (EUR 2.34B, down a third as generics spread in Europe and Japan).
Xarelto'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.
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 →
Copies on the US market Lupin launched the first US generic, a 2.5 mg tablet, in March 2025 after a patent board ruling. The FDA has since approved generics of every strength from about 20 makers. J&J and Bayer are still suing several of them over later patents.
| Company (product) | Stage |
|---|---|
| Lupin | Launched 2.5 mg, March 2025 |
| Dr. Reddy's | FDA-approved, May 2025 |
| Aurobindo | FDA-approved, 2025 |
| Biocon | FDA-approved, May 2025 |
| Macleods | FDA-approved, May 2025 |
| Breckenridge | FDA-approved, May 2025 |
From the FDA's own approval lists; FDA approval does not always mean a product has launched. Checked October 2026. Sources: FDA Orange Book: rivaroxaban generics · HCPLive: first generic approved · J&J 10-K 2025
Xarelto was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 62% below its list price. US generics had already launched by then. 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.
Xarelto is 5.1% of Bayer's 2025 revenue (≈$2.6B of $51.5B). Group sales EUR 45.6B, including Crop Science and Consumer Health.
Xarelto is 2.8% of Johnson & Johnson's 2025 revenue (≈$2.6B of $94.2B). With Stelara, Simponi, Opsumit, 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. Xarelto is highlighted.