Temodar

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

TEMODAR (temozolomide - capsule; oral)

• 
  Manufacturer: SCHERING
  
  Approval date: August 11, 1999
  
  Strength(s): 100MG ^[AB], 20MG ^[AB], 250MG ^[RLD][AB], 5MG ^[AB]


• 
  Manufacturer: SCHERING
  
  Approval date: October 19, 2006
  
  Strength(s): 140MG ^[AB], 180MG ^[AB]

TEMODAR (temozolomide - powder; intravenous)

• 
  Manufacturer: SCHERING
  
  Approval date: February 27, 2009
  
  Strength(s): 100MG/VIAL ^[RLD]

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): 100MG ^[AB], 140MG ^[AB], 180MG ^[AB], 20MG ^[AB], 250MG ^[AB], 5MG ^[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
  
  

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:
  • March 15, 2012 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Temodar Consumer Information (Drugs.com)
• Temodar Consumer Information (Wolters Kluwer)
• Temodar Consumer Information (Cerner Multum)
• Temodar Advanced Consumer Information (Micromedex)
• Temodar Intravenous Advanced Consumer Information (Micromedex)
• Temodar AHFS DI Monographs (ASHP)
• Temozolomide Consumer Information (Wolters Kluwer)
• Temozolomide Consumer Information (Cerner Multum)
• Temozolomide Advanced Consumer Information (Micromedex)
• Temozolomide Intravenous Advanced Consumer Information (Micromedex)
• Temozolomide AHFS DI Monographs (ASHP)