Generic Xeljanz Availability
Last updated on Apr 10, 2025.
See also: Generic Xeljanz XR
Xeljanz is a brand name of tofacitinib, approved by the FDA in the following formulation(s):
XELJANZ (tofacitinib citrate - solution;oral)
XELJANZ (tofacitinib citrate - tablet;oral)
-
Manufacturer: PF PRISM CV
Approval date: November 6, 2012
Strength(s): EQ 5MG BASE [RLD] -
Manufacturer: PF PRISM CV
Approval date: May 30, 2018
Strength(s): EQ 10MG BASE [RLD]
Is there a generic version of Xeljanz available?
No. There is currently no therapeutically equivalent version of Xeljanz available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xeljanz. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pyrrolo[2,3-D]pyrimidine compounds
Patent RE41783
Issued: September 28, 2010
Inventor(s): Blumenkopf; Todd A. et al.
Assignee(s): Pfizer Inc. (Madison, NJ)A compound of the formula ##STR00001## wherein R.sup.1, R.sup.2 and R.sup.3 are as defined above, which are inhibitors of the enzyme protein kinases such as Janus Kinase 3 and as such are useful therapy as immunosuppressive agents for organ transplants, xeno transplation, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes and complications from diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disorders, ulcerative colitis, Crohn's disease, Alzheimer's disease, Leukemia and other autoimmune diseases.
Patent expiration dates:
- December 8, 2025✓
- December 8, 2025
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Pyrrolo[2,3-D]pyrimidine compounds
Patent RE41783*PED
Issued: September 28, 2010
Inventor(s): Blumenkopf; Todd A. et al.
Assignee(s): Pfizer Inc. (Madison, NJ)A compound of the formula ##STR00001## wherein R.sup.1, R.sup.2 and R.sup.3 are as defined above, which are inhibitors of the enzyme protein kinases such as Janus Kinase 3 and as such are useful therapy as immunosuppressive agents for organ transplants, xeno transplation, lupus, multiple sclerosis, rheumatoid arthritis, psoriasis, Type I diabetes and complications from diabetes, cancer, asthma, atopic dermatitis, autoimmune thyroid disorders, ulcerative colitis, Crohn's disease, Alzheimer's disease, Leukemia and other autoimmune diseases.
Patent expiration dates:
- June 8, 2026✓
- June 8, 2026
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- February 21, 2028 - ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
- August 21, 2028 - PEDIATRIC EXCLUSIVITY
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
