Generic Temodar Availability

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

TEMODAR (temozolomide - capsule;oral)

TEMODAR (temozolomide - powder;intravenous)

Has a generic version of Temodar been approved?

A generic version of Temodar 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 Temodar and have been approved by the FDA:

temozolomide capsule;oral

  • Manufacturer: BARR
    Approval date: March 1, 2010
    Strength(s): 5MG [AB], 20MG [AB], 100MG [AB], 140MG [AB], 180MG [AB], 250MG [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: February 12, 2014
    Strength(s): 5MG [AB], 20MG [AB], 100MG [AB], 140MG [AB], 180MG [AB], 250MG [AB]

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

  • temozolomide - powder;intravenous

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: About generic drugs.

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.

  • Tetrazine derivatives
    Patent 5,260,291
    Issued: November 9, 1993
    Inventor(s): Lunt; Edward & Stevens; Malcolm F. G. & Stone; Robert & Wooldridge; Kenneth R. H. & Newlands; Edward S.
    Assignee(s): Cancer Research Campaign Technology Limited
    [ 3H]-Imidazo[ 5,1-d] -1,2,3,5-tetrazin-4-one derivatives of the formula: ##STR1## wherein R.sup.1 represents hydrogen, or an alkyl, alkenyl or alkynyl group containing up to 6 carbon atoms, each such group being unsubstituted or substituted by from one to three substituents selected from halogen atoms, alkoxy, alkylthio, alkylsulphinyl and alkylsulphonyl groups containing up to 4 carbon atoms, and optionally substituted phenyl groups, or R.sup.1 represents a cycloalkyl group containing from 3 to 8 carbon atoms, and R.sup.2 represents a carbamoyl group optionally N-substituted by one or two groups selected ftom alkyl and alkenyl groups containing up to 4 carbon atoms, and cycloalkyl groups containing 3 to 8 carbon atoms, are new therapeutically useful compounds possessing antineoplastic and immunomodulatory activity.
    Patent expiration dates:
    • August 11, 2013
      ✓ 
      Patent use: TREATMENT OF MALIGNANT NEOPLASM
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 11, 2014
      ✓ 
      Pediatric exclusivity
  • 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

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.

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