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Generic Temodar Availability

Last updated on Mar 9, 2023.

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

TEMODAR (temozolomide - capsule;oral)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: August 11, 1999
    Strength(s): 5MG (discontinued) [RLD], 20MG (discontinued) [RLD], 100MG (discontinued) [RLD], 250MG (discontinued) [RLD]
  • Manufacturer: MERCK SHARP DOHME
    Approval date: October 19, 2006
    Strength(s): 140MG (discontinued) [RLD], 180MG (discontinued) [RLD]

TEMODAR (temozolomide - powder;intravenous)

Has a generic version of Temodar been approved?

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

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

  • Pharmaceutical formulations of antineoplastic agents and processes of making and using the same
    Patent 6,987,108
    Issued: January 17, 2006
    Inventor(s): Ugwu; Sydney & Radhakrishnan; Vinay & Ihnat; Peter M. & Witchey-Lakshmanan; Leonore C.
    Assignee(s): Schering Corporation

    In its several embodiments, this invention discloses a pharmaceutical formulation comprising at least one antineoplastic agent or a pharmaceutically acceptable salt thereof, and at least one dissolution enhancing agent sufficient to substantially dissolve said at least one antineoplastic agent in at least one aqueous diluent, wherein said dissolution enhancing agent is urea, L-histidine, L-threonine, L-asparagine, L-serine, L-glutamine or mixtures thereof; a lyophilized powder comprising said pharmaceutical formulation, and articles of manufacture thereof.

    Patent expiration dates:

    • September 8, 2023
      ✓ 
      Drug product
  • Pharmaceutical formulations of antineoplastic agents
    Patent 7,786,118
    Issued: August 31, 2010
    Inventor(s): Ugwu; Sydney & Radhakrishnan; Vinay & Ihnat; Peter M. & Witchey-Lakshmanan; Leonore C.
    Assignee(s): Schering Corporation

    In its several embodiments, this invention discloses a pharmaceutical formulation comprising at least one antineoplastic agent or a pharmaceutically acceptable salt thereof, and at least one dissolution enhancing agent sufficient to substantially dissolve said at least one antineoplastic agent in at least one aqueous diluent, wherein said dissolution enhancing agent is urea, L-histidine, L-threonine, L-asparagine, L-serine, L-glutamine or mixtures thereof; a lyophilized powder comprising said pharmaceutical formulation, and articles of manufacture thereof.

    Patent expiration dates:

    • February 21, 2023
      ✓ 
      Drug product
  • Processes of making and using pharmaceutical formulations of antineoplastic agents
    Patent 8,623,868
    Issued: January 7, 2014
    Assignee(s): Merck Sharp & Dohme Corp.

    In its several embodiments, this invention discloses a pharmaceutical formulation comprising at least one antineoplastic agent or a pharmaceutically acceptable salt thereof, and at least one dissolution enhancing agent sufficient to substantially dissolve said at least one antineoplastic agent in at least one aqueous diluent, wherein said dissolution enhancing agent is urea, L-histidine, L-threonine, L-asparagine, L-serine, L-glutamine or mixtures thereof; a lyophilized powder comprising said pharmaceutical formulation, and articles of manufacture thereof.

    Patent expiration dates:

    • February 21, 2023
      ✓ 
      Drug product

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.

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