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)
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.
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Patent 10,452,815
Patent expiration dates:
- June 29, 2038✓✓
- June 29, 2038
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Patent 10452815*
Patent expiration dates:
- December 29, 2038
- December 29, 2038
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Patent 10,478,441
Patent expiration dates:
- May 3, 2033✓
- May 3, 2033
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Patent 10478441*
Patent expiration dates:
- November 3, 2033
- November 3, 2033
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Patent 10,478,442
Patent expiration dates:
- May 3, 2033✓
- May 3, 2033
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Patent 10478442*
Patent expiration dates:
- November 3, 2033
- November 3, 2033
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Patent 10,603,290
Patent expiration dates:
- August 2, 2037✓
- August 2, 2037✓
- August 2, 2037
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Patent 10603290*
Patent expiration dates:
- February 2, 2038
- February 2, 2038
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Patent 10,947,183
Patent expiration dates:
- December 20, 2036✓✓
- December 20, 2036
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Patent 10947183*
Patent expiration dates:
- June 20, 2037
- June 20, 2037
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Patent 11,040,018
Patent expiration dates:
- August 2, 2037✓
- August 2, 2037✓
- August 2, 2037
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Patent 11040018*
Patent expiration dates:
- February 2, 2038
- February 2, 2038
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Patent 11,406,606
Patent expiration dates:
- August 2, 2037✓
- August 2, 2037✓
- August 2, 2037
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Patent 11406606*
Patent expiration dates:
- February 2, 2038
- February 2, 2038
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Patent 9,549,909
Patent expiration dates:
- May 3, 2033✓
- November 3, 2033✓
- May 3, 2033
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Patent 9,603,814
Patent expiration dates:
- May 3, 2033✓
- November 3, 2033✓
- May 3, 2033
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Patent 9,603,815
Patent expiration dates:
- May 3, 2033✓
- November 3, 2033✓
- May 3, 2033
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Patent 9,610,260
Patent expiration dates:
- May 3, 2033✓
- November 3, 2033✓
- May 3, 2033
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
More about Fintepla (fenfluramine)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: CNS stimulants
- En español
Patient resources
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Related treatment guides
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.