Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
TOFACITINIB | A209923 | PRINSTON PHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Pfizer Inc. et al v. Prinston Pharmaceutical Inc. 1 patentANDA 209923tofacitinib citrate | D. Del. | 2025-09-26 | Terminated 2025-10-03 | — |
Pfizer Inc. et al v. Prinston Pharmaceutical Inc. 1 patentANDA 209923tofacitinib citrate | D. Del. | 2018-03-09 | Terminated 2019-02-07 | — |
Pfizer Inc. et al v. Zydus Pharmaceuticals (USA) Inc. et al 2 patentsANDA 209923tofacitinib citrate | D. Del. | 2017-02-14 | Terminated 2020-11-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.