FDA Orange Book · active-ingredient family
Tofacitinib citrate
Tofacitinib citrate is approved as 3 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XELJANZ · NDA 213082
3
Brand (NDA)
25
Generics (ANDA)
8
Listed patents
4
Exclusivity periods
Brand (NDA) products · solution, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XELJANZRLD | PFIZER | NDA 213082 | AA | Sep 25, 2020 | |
| XELJANZ XRRLD×2 | PFIZER | NDA 208246 | AB | Feb 23, 2016 | |
| XELJANZRLD×2 | PF PRISM CV | NDA 203214 | AB | Nov 06, 2012 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOFACITINIB CITRATE | AUSON | ANDA 219370 | AA | Jun 09, 2026 | |
| TOFACITINIB CITRATE | SAPTALIS PHARMS | ANDA 218900 | AA | Jun 09, 2026 | |
| TOFACITINIB CITRATE | ORIENT PHARMA | ANDA 219830 | AB | Jun 09, 2026 | |
| TOFACITINIB CITRATE×2 | CONCORD BIOTECH LTD | ANDA 218821 | AB | Jun 09, 2026 | |
| TOFACITINIB CITRATE×2 | YAOPHARMA CO LTD | ANDA 215552 | AB | Jun 09, 2026 | |
| TOFACITINIB CITRATE | MSN | ANDA 217298 | AA | Jun 03, 2026 | |
| TOFACITINIB CITRATE | SUN PHARM INDS INC | ANDA 218407 | AA | Jun 03, 2026 | |
| TOFACITINIB CITRATE | APOTEX | ANDA 220458 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | APOTEX | ANDA 218096 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | AUROBINDO PHARMA LTD | ANDA 215356 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | BRECKENRIDGE | ANDA 209633 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | MACLEODS PHARMS LTD | ANDA 219530 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | MSN | ANDA 217299 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | SOMERSET THERAPS LLC | ANDA 220137 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE×2 | SPECGX LLC | ANDA 219395 | AB | Jun 03, 2026 | |
| TOFACITINIB CITRATE | BIOCON PHARMA | ANDA 219442 | AB | Nov 17, 2025 | |
| TOFACITINIB CITRATE | SINOTHERAPEUTICS INC | ANDA 216001 | AB | Sep 30, 2025 | |
| TOFACITINIB CITRATE | AJANTA PHARMA LTD | ANDA 219542 | AB | Aug 19, 2025 | |
| TOFACITINIB CITRATE | DEXCEL | ANDA 218668 | AB | Dec 16, 2024 | |
| TOFACITINIB CITRATE | AUROBINDO PHARMA LTD | ANDA 218462 | AB | Jun 03, 2024 | |
| TOFACITINIB CITRATE | HIKMA | ANDA 216878 | AA | Sep 25, 2023 | |
| TOFACITINIB CITRATE×2 | MICRO LABS | ANDA 209738 | AB | Mar 13, 2023 | |
| TOFACITINIB CITRATE×2 | ZYDUS PHARMS | ANDA 209829 | AB | Mar 13, 2023 | |
| TOFACITINIB CITRATE×2 | ZYDUS PHARMS | ANDA 214264 | AB | Aug 19, 2021 | |
| TOFACITINIB CITRATE | AJANTA PHARMA LTD | ANDA 212943 | AB | Jun 01, 2021 |
Marketing exclusivity (4)
- M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 2 mo
- M-14New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
Aug 21, 2028
in 2 yr 2 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE41783 | Dec 08, 2025 | 6 mo ago | Substance |
| RE41783*PED | Jun 08, 2026 | 11 d ago | |
| 11253523 | Mar 14, 2034 | in 7 yr 10 mo | U-3326 |
| 9937181 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 10639309 | Mar 14, 2034 | in 7 yr 10 mo | Product |
| 9937181*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 11253523*PED | Sep 14, 2034 | in 8 yr 4 mo | |
| 10639309*PED | Sep 14, 2034 | in 8 yr 4 mo |
Tofacitinib citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
