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Generic Zorvolex Availability

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

ZORVOLEX (diclofenac - capsule;oral)

  • Manufacturer: IROKO PHARMS LLC
    Approval date: October 18, 2013
    Strength(s): 18MG, 35MG [RLD]

Has a generic version of Zorvolex been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zorvolex. 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 diclofenac
    Patent 8,679,544
    Issued: March 25, 2014
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of diclofenac
    Patent 8,999,387
    Issued: April 7, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Formulation of diclofenac
    Patent 9,017,721
    Issued: April 28, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of diclofenac
    Patent 9,173,854
    Issued: November 3, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of diclofenac
    Patent 9,180,095
    Issued: November 10, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Patent use: TREATMENT OF PAIN
  • Formulation of diclofenac
    Patent 9,180,096
    Issued: November 10, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac administered by way of said medicaments.
    Patent expiration dates:
    • April 23, 2030
      ✓ 
      Drug product
  • Formulation of diclofenac
    Patent 9,186,328
    Issued: November 17, 2015
    Assignee(s): iCeutica Pty Ltd.
    The present invention relates to methods for producing particles of diclofenac using dry milling processes as well as compositions comprising diclofenac, medicaments produced using diclofenac in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of diclofenac 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:
    • October 18, 2016 - NEW PRODUCT
    • August 22, 2017 - INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN.

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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