Generic Taxotere Availability

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

TAXOTERE (docetaxel - injectable; injection)

Has a generic version of Taxotere been approved?

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

docetaxel injectable; injection

  • Manufacturer: ACCORD HLTHCARE
    Approval date: April 20, 2012
    Strength(s): 20MG/ML (20MG/ML) [AP], 80MG/4ML (20MG/ML) [AP]
  • Manufacturer: ACTAVIS INC
    Approval date: April 12, 2013
    Strength(s): 20MG/ML (20MG/ML) [AP], 80MG/4ML (20MG/ML) [AP]

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:
    • May 13, 2013 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • November 13, 2013 - PEDIATRIC EXCLUSIVITY

See also...

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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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