FDA Orange Book
Generic for Xeljanz
Xeljanz 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 is tofacitinib. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Xeljanz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 1MG BASE/ML | Marketed (Rx) | AA | 5 | AA |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 11 | AB |
NDA 213082, 203214, 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 |
|---|---|---|---|---|
| AJANTA PHARMA LTD | 212943 | AB (A-rated, therapeutically equivalent) | June 1, 2021 | EQ 10MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 216878 | AA (A-rated, therapeutically equivalent) | September 25, 2023 | EQ 1MG BASE/ML |
| MSN LABORATORIES PRIVATE LTD | 217298 | AA (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 1MG BASE/ML |
| SUN PHARMACEUTICAL INDUSTRIES INC | 218407 | AA (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 1MG BASE/ML |
| APOTEX INC | 218096 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 215356 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| BRECKENRIDGE PHARMACEUTICAL INC | 209633 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 219530 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| MICRO LABS LTD | 209738 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| MSN LABORATORIES PRIVATE LTD | 217299 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| SOMERSET THERAPEUTICS LLC | 220137 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| SPECGX LLC | 219395 | AB (A-rated, therapeutically equivalent) | June 3, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 209829 | AB (A-rated, therapeutically equivalent) | June 5, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| PHARMACO LLC | 219370 | AA (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 1MG BASE/ML |
| SAPTALIS PHARMACEUTICALS LLC | 218900 | AA (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 1MG BASE/ML |
| CONCORD BIOTECH LTD | 218821 | AB (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 10MG BASE, EQ 5MG BASE |
| YAOPHARMA CO LTD | 215552 | AB (A-rated, therapeutically equivalent) | June 9, 2026 | EQ 10MG BASE, EQ 5MG BASE |
Xeljanz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE41783 | December 8, 2025 | Drug substance | None | 213082 |
| RE41783*PED | June 8, 2026 | Method of use | None | 213082 |
Xeljanz exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | February 21, 2028 | 213082 |
| PED | Pediatric exclusivity | August 21, 2028 | 213082 |
Xeljanz NDC codes
Questions
Is there a generic for Xeljanz?
Yes. The generic name for Xeljanz is tofacitinib. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Xeljanz?
The active ingredient in Xeljanz is tofacitinib, per the FDA Orange Book.
When does the Xeljanz patent expire?
The last patent listed for Xeljanz in the Orange Book expires June 8, 2026. 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.
More on Xeljanz and Tofacitinib
- What is Xeljanz used for?FDA label uses
- Is Xeljanz a controlled substance?Federal schedule
- What is Tofacitinib used for?FDA label uses
- Is Tofacitinib a controlled substance?Federal schedule
- Generic for Xeljanz XRFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Xeljanz Medicare Part D coverageBy plan and state
- NDC 0069-0501Xeljanz NDC record
- NDC 0069-0502Xeljanz NDC record
- NDC 0069-1001Xeljanz NDC record