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Generic Sernivo Availability

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

SERNIVO (betamethasone dipropionate - spray;topical)

  • Manufacturer: PROMIUS PHARMA LLC
    Approval date: February 5, 2016
    Strength(s): EQ 0.05% BASE/SPRAY [RLD]

Has a generic version of Sernivo been approved?

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

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

  • Topical formulations comprising a steroid
    Patent 9,364,485
    Issued: June 14, 2016
    Assignee(s): DR. REDDY'S LABORATORIES LTD.
    The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
    Patent expiration dates:
    • August 31, 2030
      ✓ 
      Patent use: TREATMENT OF PLAQUE PSORIASIS
      ✓ 
      Drug product
  • Topical formulations comprising a steroid
    Patent 9,433,630
    Issued: September 6, 2016
    Assignee(s): Dr. Reddy's Laboratories Ltd.
    The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
    Patent expiration dates:
    • August 31, 2030
      ✓ 
      Patent use: TREATMENT OF PLAQUE PSORIASIS
      ✓ 
      Drug product
  • Topical formulations comprising a steroid
    Patent 9,439,911
    Issued: September 13, 2016
    Assignee(s): Dr. Reddy's Laboratories Ltd.
    The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
    Patent expiration dates:
    • August 31, 2030
      ✓ 
      Patent use: TREATMENT OF PLAQUE PSORIASIS
      ✓ 
      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:
    • February 5, 2019 - NEW DOSAGE FORM

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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