tofacitinib citrate · Pfizer · NDA 208246
Xeljanz Xr
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Sep 2034
Blocked by patent: US 10639309, US 11253523, US 9937181.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10639309 | — | 14 Sep 2034 |
| US 11253523 | — | 14 Sep 2034 |
| US 9937181 | — | 14 Sep 2034 |
| US 10639309 | product | 14 Mar 2034 |
| US 11253523 | use U-3328 | 14 Mar 2034 |
| US 11253523 | use U-3329 | 14 Mar 2034 |
| US 11253523 | use U-3326 | 14 Mar 2034 |
| US 11253523 | use U-3327 | 14 Mar 2034 |
| US 9937181 | product | 14 Mar 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 · 208246-00130 Sep 2025
- 25 Oct 2026Generic tentatively approved · 208246-00117 Nov 2025
- 25 Oct 2026Generic approved · 208246-00125 Jun 2026
- 25 Oct 2026Generic approved · 208246-0019 Jun 2026
- 25 Oct 2026Generic approved · 208246-0013 Jun 2026
- 25 Oct 2026Generic approved · 208246-00117 Aug 2026
- 25 Oct 2026Generic approved · 208246-00119 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208246 · 001 · RLD | tablet, extended release, oral | EQ 11MG BASE | 14 Sep 2034 |
| 208246 · 002 · RLD | tablet, extended release, oral | EQ 22MG BASE | 14 Sep 2034 |
Expired or delisted (2)
- US RE41783 · — · 8 Jun 2026
- US RE41783 · substance · 8 Dec 2025