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Generic Scenesse Availability

Last updated on July 7, 2021.

Scenesse is a brand name of afamelanotide, approved by the FDA in the following formulation(s):

SCENESSE (afamelanotide - implant;subcutaneous)

  • Manufacturer: CLIVUNEL INC
    Approval date: October 8, 2019
    Strength(s): 16MG [RLD]

Has a generic version of Scenesse been approved?

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

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

  • Methods of inducing melanogenesis in a subject
    Patent 10,076,555
    Issued: September 18, 2018
    Assignee(s): Clinuvel Pharmaceuticals Limited

    Described herein are methods and compositions for inducing melanogenesis in a human subject. The method comprises administering to a subject an alpha-MSH analogue, in an effective amount and time to induce melanogenesis by the melanocytes in epidermal tissue of subject without inducing homologous desensitization of the melanocortin-1 receptors.

    Patent expiration dates:

    • February 11, 2025
      ✓ 
      Patent use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
  • Method of treatment of photodermatoses
    Patent 8,334,265
    Issued: December 18, 2012
    Inventor(s): Wolgen; Philippe
    Assignee(s): Clinuvel Pharmaceuticals Limited

    This invention relates to a method for prophylactic or therapeutic treatment of photodermatoses that are caused or exacerbated by or associated with UVR exposure in a subject, particularly a human subject, which comprises the step of administering to said subject an amount of an alpha-MSH analogue effective to reduce the photosensitivity of the skin of the subject.

    Patent expiration dates:

    • March 11, 2029
      ✓ 
      Patent use: INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)

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:

    • October 8, 2024 - NEW CHEMICAL ENTITY
    • October 8, 2026 -

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.