tofacitinib citrate · Pf Prism Cv · NDA 203214, 213082
Xeljanz
1 of 3 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by exclusivity: PED.
FDA has approved 16 generic applications (ANDAs) for Xeljanz, though its earliest generic-entry date is 21 Aug 2028 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 21 Aug 2028 |
| M-14 | miscellaneous (3 years) | 21 Feb 2028 |
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
- Generic approved · ANDA 218096, Apotex · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219530, Macleods Pharms · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220137, Somerset Theraps Llc · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 215552, Yaopharma Co Ltd · 203214-001Approved 9 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 209633, Breckenridge · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218900, Saptalis Pharms · 213082-001Approved 9 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219395, Specgx Llc · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219370, Pharmaco · 213082-001Approved 9 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218407, Sun Pharm Inds Inc · 213082-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218821, Concord Biotech Ltd · 203214-001Approved 9 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 215356, Aurobindo Pharma Ltd · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 212943, Ajanta Pharma Ltd · 203214-001Approved 20 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 209829, Zydus Pharms · 203214-001Approved 5 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 209738, Micro Labs · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217298, Msn · 213082-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217299, Msn · 203214-001Approved 3 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203214 · 001 · RLD | tablet, oral | EQ 5MG BASE | 21 Aug 2028 |
| 203214 · 002 · RLD | tablet, oral | EQ 10MG BASE | open |
| 213082 · 001 · RLD | solution, oral | EQ 1MG BASE/ML | 21 Aug 2028 |
Expired or delisted (2)
- US RE41783 · — · 8 Jun 2026
- US RE41783 · substance · 8 Dec 2025