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Generic Xeljanz Availability

Last updated on Sep 8, 2022.

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)

  • Manufacturer: PFIZER
    Approval date: September 25, 2020
    Strength(s): EQ 1MG/ML BASE [RLD]

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]

Has a generic version of Xeljanz been approved?

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.

  • Crystalline 3-{4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile citrate
    Patent 6,965,027
    Issued: November 15, 2005
    Inventor(s): Flanagan; Mark E. & Li; Zheng J.
    Assignee(s): Pfizer Inc.

    This invention relates to novel amorphous and crystallline forms of 3-{(3R,4R)-4-methyl-3-[methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino]-piperidin-1-yl}-3-oxo-propionitrile mono citrate salt, useful as inhibitors of protein kinases, and to their methods of preparation.

    Patent expiration dates:

    • March 25, 2023
      ✓ 
      Drug substance
  • Pyrrolo[2,3-D]pyrimidine compounds
    Patent RE41783
    Issued: September 28, 2010
    Inventor(s): Blumenkopf; Todd A. & Flanagan; Mark E. & Munchhof; Michael J.
    Assignee(s): Pfizer Inc.

    A compound of the formula wherein R1, R2 and R3 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
      ✓ 
      Drug substance

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:

    • September 25, 2023 - NEW PATIENT POPULATION
    • September 25, 2023 - NEW PRODUCT
    • December 14, 2024 - TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION

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.