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Generic Bryhali Availability

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

BRYHALI (halobetasol propionate - lotion;topical)

  • Manufacturer: BAUSCH
    Approval date: November 6, 2018
    Strength(s): 0.01% [RLD]

Has a generic version of Bryhali been approved?

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

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

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.

  • Patent 10,478,502

    Patent expiration dates:

    • November 2, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
      ✓ 
      Drug product
  • Topical gel delivery system
    Patent 6,517,847
    Issued: February 11, 2003
    Inventor(s): Gordon J.; Dow & Robert W.; Lathrop & Debra A.; Dow
    Assignee(s): Dow Pharmaceutical Sciences

    A composition is provided that has a viscosity of less than about 15,000 cP and a pH of about 3.0 to 9.0 for treating a skin disorder in a human subject. The composition is a lotion that consists essentially of (a) a therapeutically-effective amount of at least one compound useful for treating such disorder, (b) a pharmaceutically-acceptable, lightly cross-linked polyacrylic acid polymer compatible with the compound, (c) a pharmaceutically acceptable base to adjust pH, (d) up to about 25% ww of at least one water miscible solvent, (e) optionally a preservative, (f) water, and (g) an oil phase component and suitable surfactant. The composition is useful for treating an inflammatory skin disorder, acne, or rosacea.

    Patent expiration dates:

    • August 3, 2020
      ✓ 
      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:

    • November 6, 2021 - NEW PRODUCT

Further information

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

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.