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Generic Xatmep Availability

Last updated on Oct 6, 2021.

Xatmep is a brand name of methotrexate, approved by the FDA in the following formulation(s):

XATMEP (methotrexate sodium - solution;oral)

  • Manufacturer: AZURITY
    Approval date: April 25, 2017
    Strength(s): EQ 2.5MG BASE/ML [RLD]

Has a generic version of Xatmep been approved?

No. There is currently no therapeutically equivalent version of Xatmep available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xatmep. 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.

  • Methotrexate composition
    Patent 10,231,927
    Issued: March 19, 2019
    Assignee(s): Rosemont Pharmaceuticals Ltd.

    A Methotrexate composition for oral administration is provided comprising a pharmaceutically acceptable salt of Methotrexate and an aqueous carrier agent. The Methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. There is also provided a method of manufacturing a Methotrexate composition for oral administration, comprising mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent until the Methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution.

    Patent expiration dates:

    • January 2, 2033
      ✓ 
      Patent use: A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
    • January 2, 2033
      ✓ 
      Patent use: TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
  • Patent 10,610,485

    Patent expiration dates:

    • January 2, 2033
      ✓ 
      Drug product
  • Methotrexate composition
    Patent 9,259,427
    Issued: February 16, 2016
    Assignee(s): Rosemont Pharmaceuticals LTD

    A Methotrexate composition for oral administration is provided comprising a pharmaceutically acceptable salt of Methotrexate and an aqueous carrier agent. The Methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. There is also provided a method of manufacturing a Methotrexate composition for oral administration, comprising mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent until the Methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution.

    Patent expiration dates:

    • January 2, 2033
      ✓ 
      Drug product
  • Methotrexate composition
    Patent 9,855,215
    Issued: January 2, 2018
    Assignee(s): Rosemont Pharmaceuticals Ltd.

    A Methotrexate composition for oral administration is provided comprising a pharmaceutically acceptable salt of Methotrexate and an aqueous carrier agent. The Methotrexate salt is substantially or completely soluble in the aqueous carrier agent, forming an aqueous solution. There is also provided a method of manufacturing a Methotrexate composition for oral administration, comprising mixing a pharmaceutically acceptable salt of Methotrexate with an aqueous carrier agent until the Methotrexate salt is substantially or completely soluble in the carrier agent to form an aqueous solution.

    Patent expiration dates:

    • January 2, 2033
      ✓ 
      Drug product

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:

    • April 25, 2024 -
    • April 25, 2024 -

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.