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Generic Copaxone Availability

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

COPAXONE (glatiramer acetate - injectable;subcutaneous)

  • Manufacturer: TEVA PHARMS USA
    Approval date: February 12, 2002
    Strength(s): 20MG/ML [RLD] [AP]
  • Manufacturer: TEVA PHARMS USA
    Approval date: January 28, 2014
    Strength(s): 40MG/ML [RLD]

Has a generic version of Copaxone been approved?

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

GLATOPA (glatiramer acetate injectable;subcutaneous)

  • Manufacturer: SANDOZ INC
    Approval date: April 16, 2015
    Strength(s): 20MG/ML [AP]

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

  • Low frequency glatiramer acetate therapy
    Patent 8,232,250
    Issued: July 31, 2012
    Inventor(s): Klinger; Ety
    Assignee(s): Yeda Research & Development Co., Ltd.
    A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.
    Patent expiration dates:
    • August 19, 2030
      ✓ 
      Patent use: METHOD OF TREATING MS BY ADMINISTERING COPAXONE
  • Low frequency glatiramer acetate therapy
    Patent 8,399,413
    Issued: March 19, 2013
    Assignee(s): Yeda Research & Development Co., Ltd.
    A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.
    Patent expiration dates:
    • August 19, 2030
      ✓ 
      Patent use: METHOD OF TREATING MS BY ADMINISTERING COPAXONE
  • Low frequency glatiramer acetate therapy
    Patent 8,969,302
    Issued: March 3, 2015
    Assignee(s): Yeda Research & Development Co., Ltd.
    A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.
    Patent expiration dates:
    • August 19, 2030
      ✓ 
      Patent use: METHOD OF TREATING MS BY ADMINISTERING COPAXONE

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:
    • January 28, 2017 -

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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