Skip to Content

Generic Enstilar Availability

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

ENSTILAR (betamethasone dipropionate; calcipotriene - aerosol, foam;topical)

  • Manufacturer: LEO PHARMA AS
    Approval date: October 16, 2015
    Strength(s): 0.064%;0.005% [RLD]

Has a generic version of Enstilar been approved?

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

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

  • Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
    Patent 10,130,640
    Issued: November 20, 2018
    Assignee(s): Leo Pharma A/S

    The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative or analog and a corticosteroid, and its use in the treatment of dermal diseases and conditions.

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Drug product
  • Patent 10130640*

    Patent expiration dates:

    • December 10, 2031
  • Patent 10,617,698

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Drug product
  • Patent 10,660,908

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
      ✓ 
      Drug product
  • Patent 10,682,364

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Drug product
  • Patent 10,688,108

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
  • Patent 10,716,799

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Drug product
  • Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
    Patent 9,119,781
    Issued: September 1, 2015
    Assignee(s): LEO PHARMA A/S

    The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative and a corticosteroid, and its use in the treatment of dermal diseases and conditions. The spray comprises especially a propellant selected from the group consisting of dimethyl ether, diethyl ether and methylethyl ether or a mixture thereof and further a pharmaceutically acceptable lipid carrier solubilised or suspended in said propellant.

    Patent expiration dates:

    • June 10, 2031
      ✓ 
      Patent use: PLAQUE PSORIASIS
      ✓ 
      Drug product
    • June 10, 2031
      ✓ 
      Patent use: TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
      ✓ 
      Drug product
    • December 10, 2031
      ✓ 
      Pediatric exclusivity
  • Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid
    Patent 9,566,286
    Issued: February 14, 2017
    Assignee(s): LEO PHARMA A/S

    The present invention relates to a topical spray composition comprising a biologically active vitamin D derivative or analog and a corticosteroid, and its use in the treatment of dermal diseases and conditions.

    Patent expiration dates:

    • June 10, 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:

    • July 30, 2022 - NEW PATIENT POPULATION
    • January 30, 2023 - PEDIATRIC EXCLUSIVITY

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.