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Generic Duobrii Availability

Last updated on Oct 6, 2021.

Duobrii is a brand name of halobetasol/tazarotene topical, approved by the FDA in the following formulation(s):

DUOBRII (halobetasol propionate; tazarotene - lotion;topical)

  • Manufacturer: BAUSCH
    Approval date: April 25, 2019
    Strength(s): 0.01%;0.045% [RLD]

Has a generic version of Duobrii been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Duobrii. 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 compositions and methods for treating psoriasis
    Patent 10,251,895
    Issued: April 9, 2019
    Assignee(s): Valeant Pharmaceuticals North America

    Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.

    Patent expiration dates:

    • June 6, 2036
      ✓ 
      Drug product
  • Patent 10,426,787

    Patent expiration dates:

    • June 6, 2036
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
  • Patent 10,478,502

    Patent expiration dates:

    • November 2, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
      ✓ 
      Drug product
  • Pharmaceutical formulations containing corticosteroids for topical administration
    Patent 8,809,307
    Issued: August 19, 2014
    Assignee(s): Dow Pharmaceutical Sciences, Inc.

    The potency of a topical corticosteroid in a pharmaceutical formulation is maintained even when the concentration of the corticosteroid is substantially reduced by providing the corticosteroid in a formulation containing a liquid oil component that includes a dicarboxylic acid ester and/or a monocarboxylic acid ester.

    Patent expiration dates:

    • November 2, 2031
      ✓ 
      Drug product

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:

    • April 25, 2022 - NEW 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.

Medical Disclaimer