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Generic Tivorbex Availability

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

TIVORBEX (indomethacin - capsule;oral)

  • Manufacturer: IROKO PHARMS LLC
    Approval date: February 24, 2014
    Strength(s): 20MG, 40MG [RLD]

Has a generic version of Tivorbex been approved?

No. There is currently no therapeutically equivalent version of Tivorbex available in the United States.

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

  • Formulation of indomethacin
    Patent 8,734,847
    Issued: May 27, 2014
    Assignee(s): Iceutica Py Ltd.
    The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of indomethacin
    Patent 8,992,982
    Issued: March 31, 2015
    Assignee(s): Iceutica Pty Ltd.
    The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of indomethacin
    Patent 9,089,471
    Issued: July 28, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Patent use: TREATMENT OF PAIN

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:
    • February 24, 2017 - NEW 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.
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