rivaroxaban · Janssen Pharms · NDA 022406, 215859
Xarelto
Earliest generic entry, as listed · earliest of 5 marketed strengths
17 Aug 2034
2 of 5 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 9539218.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9539218 | — | 17 Aug 2034 |
| US 9539218 | use U-1953 | 17 Feb 2034 |
| US 9539218 | use U-2641 | 17 Feb 2034 |
| US 9539218 | use U-1955 | 17 Feb 2034 |
| US 9539218 | use U-2143 | 17 Feb 2034 |
| US 9539218 | use U-3288 | 17 Feb 2034 |
| US 9539218 | use U-3289 | 17 Feb 2034 |
| US 9539218 | use U-3285 | 17 Feb 2034 |
| US 9539218 | use U-1954 | 17 Feb 2034 |
| US 9539218 | use U-1957 | 17 Feb 2034 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 022406-00114 Nov 2025
- 25 Oct 2026Generic approved · 215859-0012 Mar 2026
- 25 Oct 2026Generic approved · 022406-0017 Oct 2025
- 25 Oct 2026Generic approved · 022406-00124 Oct 2025
- 25 Oct 2026Generic approved · 022406-0011 Jul 2026
- 25 Oct 2026Generic approved · 022406-00119 Aug 2026
- 25 Oct 2026Generic approved · 022406-00120 Feb 2026
- 25 Oct 2026Generic approved · 215859-00125 Sep 2025
- 25 Oct 2026Generic approved · 022406-00130 Jun 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022406 · 001 · RLD | tablet, oral | 10MG | 17 Aug 2034 |
| 022406 · 002 · RLD | tablet, oral | 15MG | 17 Aug 2034 |
| 022406 · 003 · RLD | tablet, oral | 20MG | 17 Aug 2034 |
| 022406 · 004 · RLD | tablet, oral | 2.5MG | open |
| 215859 · 001 · RLD | for suspension, oral | 1MG/ML | open |