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Generic Fintepla Availability

Last updated on Sep 6, 2023.

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

FINTEPLA (fenfluramine hydrochloride - solution;oral)

  • Manufacturer: UCB INC
    Approval date: June 25, 2020
    Strength(s): EQ 2.2MG BASE/ML [RLD]

Has a generic version of Fintepla been approved?

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

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

  • Patent 10,452,815

    Patent expiration dates:

    • June 29, 2038
      ✓ 
      Patent use: USE OF CARDIAC MONITORING AND RESTRICTED DISTRIBUTION OF FENFLURAMINE TO MITIGATE RISK OF CARDIOVASCULAR TOXICITY IN THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
      ✓ 
      Sponsor has requested patent be delisted
  • Patent 10452815*

    Patent expiration dates:

    • December 29, 2038
  • Patent 10,478,441

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
  • Patent 10478441*

    Patent expiration dates:

    • November 3, 2033
  • Patent 10,478,442

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
  • Patent 10478442*

    Patent expiration dates:

    • November 3, 2033
  • Patent 10,603,290

    Patent expiration dates:

    • August 2, 2037
      ✓ 
      Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • August 2, 2037
      ✓ 
      Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
  • Patent 10603290*

    Patent expiration dates:

    • February 2, 2038
  • Patent 10,947,183

    Patent expiration dates:

    • December 20, 2036
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent 10947183*

    Patent expiration dates:

    • June 20, 2037
  • Patent 11,040,018

    Patent expiration dates:

    • August 2, 2037
      ✓ 
      Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • August 2, 2037
      ✓ 
      Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
  • Patent 11040018*

    Patent expiration dates:

    • February 2, 2038
  • Patent 11,406,606

    Patent expiration dates:

    • August 2, 2037
      ✓ 
      Patent use: USE OF FENFLURAMINE AT REDUCED AMOUNTS WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • August 2, 2037
      ✓ 
      Patent use: USE OF FENFLURAMINE AT REDUCED AMOUNTS WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX GASTAUT SYNDROME
  • Patent 11406606*

    Patent expiration dates:

    • February 2, 2038
  • Patent 9,549,909

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • November 3, 2033
      ✓ 
      Pediatric exclusivity
  • Patent 9,603,814

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • November 3, 2033
      ✓ 
      Pediatric exclusivity
  • Patent 9,603,815

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • November 3, 2033
      ✓ 
      Pediatric exclusivity
  • Patent 9,610,260

    Patent expiration dates:

    • May 3, 2033
      ✓ 
      Patent use: USE IN COMBINATION WITH STIRIPENTOL, VALPROATE, AND CLOBAZAM FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
    • November 3, 2033
      ✓ 
      Pediatric exclusivity

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:

    • June 25, 2023 - NEW PRODUCT
    • December 25, 2023 - PEDIATRIC EXCLUSIVITY
    • March 25, 2025 - INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER
    • September 25, 2025 - PEDIATRIC EXCLUSIVITY
    • June 25, 2027 - INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
    • December 25, 2027 - PEDIATRIC EXCLUSIVITY
    • March 25, 2029 - TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER
    • September 25, 2029 - 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.

Medical Disclaimer