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Generic Tri-Luma Availability

Last updated on Jan 11, 2023.

Tri-Luma is a brand name of fluocinolone/hydroquinone/tretinoin topical, approved by the FDA in the following formulation(s):

TRI-LUMA (fluocinolone acetonide; hydroquinone; tretinoin - cream;topical)

  • Manufacturer: GALDERMA LABS LP
    Approval date: January 18, 2002
    Strength(s): 0.01%;4%;0.05% [RLD]

Has a generic version of Tri-Luma been approved?

No. There is currently no therapeutically equivalent version of Tri-Luma available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tri-Luma. 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: Generic Drug FAQ.

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.

  • Topical skin care composition
    Patent 7,915,243
    Issued: March 29, 2011
    Inventor(s): Puglia; Nancy & Ramirez; Rosario & Roth; Jerry
    Assignee(s): Galderma S.A.

    A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.

    Patent expiration dates:

    • September 8, 2023
      ✓ 
      Drug product
  • Topical skin care composition
    Patent 7,939,516
    Issued: May 10, 2011
    Inventor(s): Puglia; Nancy & Roth; Jerry & Ramirez; Rosario
    Assignee(s): Galderma S.A.

    A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.

    Patent expiration dates:

    • September 8, 2023
      ✓ 
      Drug product
  • Topical skin care composition
    Patent 8,247,395
    Issued: August 21, 2012
    Inventor(s): Puglia; Nancy & Roth; Jerry & Ramirez; Rosario
    Assignee(s): Galderma S.A.

    A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Drug product
  • Topical skin care composition
    Patent 8,653,053
    Issued: February 18, 2014
    Assignee(s): Galderma S.A.

    A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.

    Patent expiration dates:

    • October 25, 2022
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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