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Generic Fintepla Availability

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

FINTEPLA (fenfluramine hydrochloride - solution;oral)

  • Manufacturer: ZOGENIX 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 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.

  • Patent 10,452,815

    Patent expiration dates:

    • October 22, 2039
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      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
  • 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 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 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
  • Patent 10,947,183

    Patent expiration dates:

    • September 28, 2035
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Patent 10,950,331

    Patent expiration dates:

    • September 28, 2035
      ✓ 
      Patent use: TREATMENT OF REFRACTORY EPILEPSY PATIENTS WITH FENFLURAMINE THAT REDUCES THE RISK OF CARDIOVASCULAR TOXICITY BY USING CARDIAC MONITORING AND RESTRICTED DISTRIBUTION
  • Method for the treatment of dravet syndrome
    Patent 9,549,909
    Issued: January 24, 2017
    Assignee(s): The Katholieke Universiteit Leuven University Hospital Antwerp

    A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.

    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
  • Method for the treatment of Dravet syndrome
    Patent 9,603,814
    Issued: March 28, 2017
    Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN UNIVERSITY HOSPITAL ANTWERP

    A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.

    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
  • Method for the treatment of Dravet syndrome
    Patent 9,603,815
    Issued: March 28, 2017
    Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN UNIVERSITY HOSPITAL ANTWERP

    A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.

    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
  • Method for the treatment of Dravet Syndrome
    Patent 9,610,260
    Issued: April 4, 2017
    Assignee(s): The Katholieke Universiteit Leuven University Hospital Antwerp

    A method of treating and/or preventing Dravet Syndrome in a patient such as a patient previously diagnosed with Dravet Syndrome, by administering an effective dose of fenfluramine or its pharmaceutically acceptable salt to that patient. Dravet Syndrome patients are typically children under the age of 18 and are treated at a preferred dose of less than about 0.5 to about 0.01 mg/kg/day.

    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

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
    • June 25, 2027 -

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.