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Generic Addyi Availability

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

ADDYI (flibanserin - tablet;oral)

  • Manufacturer: SPROUT PHARMS
    Approval date: August 18, 2015
    Strength(s): 100MG [RLD]

Has a generic version of Addyi been approved?

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

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

  • Method of treating female hypoactive sexual desire disorder with flibanserin
    Patent 7,151,103
    Issued: December 19, 2006
    Inventor(s): Borsini; Franco & Evans; Kenneth Robert
    Assignee(s): Boehringer Ingelheim Pharma KG
    The invention relates to the use of flibanserin, or a pharmaceutically acceptable acid addition salt thereof, for the treatment of disorders of sexual desire.
    Patent expiration dates:
    • May 9, 2023
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      Patent use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
  • Stable polymorph of flibanserin
    Patent 7,420,057
    Issued: September 2, 2008
    Inventor(s): Bombarda; Carlo & Dubini; Enrica & Ezhaya; Antoine
    Assignee(s): Boehringer Ingelheim Pharma KG
    The invention relates to the polymorph A of flibanserin, to a technical process for the preparation thereof, as well as to the use thereof for preparing medicaments.
    Patent expiration dates:
    • August 1, 2022
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      Drug substance
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      Drug product
  • Treating sexual desire disorders with flibanserin
    Patent 8,227,471
    Issued: July 24, 2012
    Inventor(s): Borsini; Franco & Evans; Kenneth Robert
    Assignee(s): Sprout Pharmaceuticals, Inc.
    The invention relates to the use of flibanserin, or a pharmaceutically acceptable acid addition salt thereof, for the treatment of disorders of sexual desire.
    Patent expiration dates:
    • May 9, 2023
      ✓ 
      Patent use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
  • Treating sexual desire disorders with flibanserin
    Patent 9,468,639
    Issued: October 18, 2016
    Assignee(s): Sprout Pharmaceuticals, Inc.
    The invention relates to the use of flibanserin, or a pharmaceutically acceptable acid addition salt thereof, for the treatment of disorders of sexual desire.
    Patent expiration dates:
    • October 16, 2022
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      Patent use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

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:
    • August 18, 2020 - NEW CHEMICAL ENTITY

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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