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Generic Xeljanz Availability

Last updated on July 7, 2021.

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] [AB]

Has a generic version of Xeljanz been approved?

A generic version of Xeljanz has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Xeljanz and have been approved by the FDA:

tofacitinib citrate tablet;oral

  • Manufacturer: AJANTA PHARMA LTD
    Approval date: June 1, 2021
    Strength(s): EQ 10MG BASE [AB]

Note: No generic formulation of the following product is available.

  • tofacitinib citrate - solution;oral

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


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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.