FDA Orange Book
Generic for Xeljanz XR
Xeljanz XR contains tofacitinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Xeljanz XR is tofacitinib. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Xeljanz XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 11MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 22MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 208246, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tofacitinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 214264 | AB (A-rated, therapeutically equivalent) | August 19, 2021 | EQ 11MG BASE, EQ 22MG BASE |
| AUROBINDO PHARMA LTD | 218462 | AB (A-rated, therapeutically equivalent) | June 3, 2024 | EQ 11MG BASE |
| DEXCEL PHARMA TECHNOLOGIES LTD | 218668 | AB (A-rated, therapeutically equivalent) | December 16, 2024 | EQ 11MG BASE |
| AJANTA PHARMA LTD | 219542 | AB (A-rated, therapeutically equivalent) | August 19, 2025 | EQ 11MG BASE |
| SINOTHERAPEUTICS INC | 216001 | AB (A-rated, therapeutically equivalent) | September 30, 2025 | EQ 11MG BASE |
| BIOCON PHARMA LTD | 219442 | AB (A-rated, therapeutically equivalent) | November 17, 2025 | EQ 11MG BASE |
| APOTEX INC | 220458 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 11MG BASE |
| ORIENT PHARMA CO LTD | 219830 | AB (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 11MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 220972 | AB (A-rated, therapeutically equivalent) | June 25, 2026 | EQ 11MG BASE |
| TEVA PHARMACEUTICALS USA INC | 209813 | AB (A-rated, therapeutically equivalent) | August 17, 2026 | EQ 11MG BASE, EQ 22MG BASE |
Xeljanz XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE41783 | December 8, 2025 | Drug substance | None | 208246 |
| RE41783*PED | June 8, 2026 | Method of use | None | 208246 |
| 11253523 | March 14, 2034 | Method of use | U-3326 | 208246 |
| 11253523 | March 14, 2034 | Method of use | U-3327 | 208246 |
| 11253523 | March 14, 2034 | Method of use | U-3328 | 208246 |
| 11253523 | March 14, 2034 | Method of use | U-3329 | 208246 |
| 9937181 | March 14, 2034 | Drug product | None | 208246 |
| 10639309 | March 14, 2034 | Drug product | None | 208246 |
| 9937181*PED | September 14, 2034 | Method of use | None | 208246 |
| 11253523*PED | September 14, 2034 | Method of use | None | 208246 |
| 10639309*PED | September 14, 2034 | Method of use | None | 208246 |
Xeljanz XR NDC codes
Questions
Is there a generic for Xeljanz XR?
Yes. The generic name for Xeljanz XR is tofacitinib. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Xeljanz XR?
The active ingredient in Xeljanz XR is tofacitinib, per the FDA Orange Book.
When does the Xeljanz XR patent expire?
The last patent listed for Xeljanz XR in the Orange Book expires September 14, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.