Taxotere

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

TAXOTERE (docetaxel - injectable; injection)

• 
  Manufacturer: SANOFI AVENTIS US
  
  Approval date: August 2, 2010
  
  Strength(s): 80MG/4ML (20MG/ML) ^[RLD]


• 
  Manufacturer: SANOFI AVENTIS US
  
  Approval date: August 3, 2010
  
  Strength(s): 20MG/ML (20MG/ML) ^[RLD]

Has a generic version of Taxotere been approved?

No. There is currently no therapeutically equivalent version of Taxotere available.

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

• 
  Taxoid-based compositions
  Patent 5,438,072
  Issued: August 1, 1995
  Inventor(s): Bobee; Jean-Marc & de Lanty; Patrick & Guerin; Gilles & Veillard; Michel
  Assignee(s): Rhone-Poulenc Rorer S.A.
  The present invention relates to new taxoid-based compositions consisting of solutions of these derivatives in a surface-active agent. These solutions are used for preparing perfusion solutions.
  
  Patent expiration dates:
  
  
  • November 22, 2013
    
    ✓ 
    Drug product
  
  
  
  • May 22, 2014
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing taxane derivatives
  Patent 5,698,582
  Issued: December 16, 1997
  Inventor(s): Bastart; Jean-Pierre & Dupechez; Thierry & Fabre; Jean-Louis
  Assignee(s): Rhone-Poulenc Rorer S.A.
  This invention relates to compositions containing taxane derivatives, consisting of a solution of such derivatives in a surfactant. These compositions can be used to prepare perfusion solutions.
  
  Patent expiration dates:
  
  
  • July 3, 2012
    
    ✓ 
    Drug product
  
  
  
  • January 3, 2013
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing taxane derivatives
  Patent 5,714,512
  Issued: February 3, 1998
  Inventor(s): Bastart; Jean-Pierre & Dupechez; Thierry & Fabre; Jean-Louis
  Assignee(s): Rhone-Poulenc Rorer, S.A.
  This invention relates to compositions containing taxane derivatives, consisting of a solution of such derivatives in a surfactant. These compositions can be used to prepare perfusion solutions.
  
  Patent expiration dates:
  
  
  • July 3, 2012
    
    ✓ 
    Drug product
  
  
  
  • January 3, 2013
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Compositions containing taxane derivatives
  Patent 5,750,561
  Issued: May 12, 1998
  Inventor(s): Bastart; Jean-Pierre & Dupechez; Thierry & Fabre; Jean-Louis
  Assignee(s): Rhone-Poulenc Rorer, S.A.
  The invention provides new compositions containing taxane derivatives, consisting of solutions of such derivatives in a solvent mixture composed of ethanol and polysorbate. These compositions are used to prepare perfusions.
  
  Patent expiration dates:
  
  
  • July 3, 2012
    
    ✓ 
    Drug product
  
  
  
  • January 3, 2013
    
    ✓ 
    Pediatric exclusivity
  
  

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 28, 2010 - EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE" PATIENTS TO ALL PATIENTS
  
  
  • September 28, 2010 - USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
  
  
  • March 28, 2011 - PEDIATRIC EXCLUSIVITY
  
  
  • May 13, 2013 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
  
  
  • November 13, 2013 - PEDIATRIC EXCLUSIVITY
  
  

See also...

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