Generic Fintepla Availability

Last updated on Apr 10, 2025.

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]

Is there a generic version of Fintepla available?

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.

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.

Control system for control of distribution of medication
Patent 10,452,815
Issued: October 22, 2019
Inventor(s): Stewart Richard Alistair Balfour & Clarke Anthony
Assignee(s): Zogenix International Limited
A system of controlling distribution of a medication in the treatment or prevention of epilepsy is provided. A central controller of the system has a data store and one or more processors for reading and writing data to the data store. The data store comprises a database of patient records, each patient record having a medication authorization field. The central controller can output an authorization of a first prescription of epilepsy medication to a patient in dependence upon genetic test results for the patient and schedules a subsequent test for the patient prior to authorization of a subsequent prescription of epilepsy medication. Also provided are methods in which the subject systems find use. The systems and methods find use in the treatment of severe subtypes of epilepsy or refractory epilepsy, such as Dravet Syndrome.
Patent expiration dates:
- June 29, 2038
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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
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  Sponsor has requested patent be delisted
Control system for control of distribution of medication
Patent 10452815*PE
Issued: October 22, 2019
Inventor(s): Stewart Richard Alistair Balfour & Clarke Anthony
Assignee(s): Zogenix International Limited
A system of controlling distribution of a medication in the treatment or prevention of epilepsy is provided. A central controller of the system has a data store and one or more processors for reading and writing data to the data store. The data store comprises a database of patient records, each patient record having a medication authorization field. The central controller can output an authorization of a first prescription of epilepsy medication to a patient in dependence upon genetic test results for the patient and schedules a subsequent test for the patient prior to authorization of a subsequent prescription of epilepsy medication. Also provided are methods in which the subject systems find use. The systems and methods find use in the treatment of severe subtypes of epilepsy or refractory epilepsy, such as Dravet Syndrome.
Patent expiration dates:
- December 29, 2038
Method for the treatment of Dravet syndrome
Patent 10,478,441
Issued: November 19, 2019
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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
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  Patent use: USE IN COMBINATION WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
Method for the treatment of Dravet syndrome
Patent 10478441*PE
Issued: November 19, 2019
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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:
- November 3, 2033
Method for the treatment of Dravet Syndrome
Patent 10,478,442
Issued: November 19, 2019
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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 FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
Method for the treatment of Dravet Syndrome
Patent 10478442*PE
Issued: November 19, 2019
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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:
- November 3, 2033
Formulation for inhibiting formation of 5-HTagonists and methods of using same
Patent 10,603,290
Issued: March 31, 2020
Inventor(s): Farr Stephen J. & Boyd Brooks
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HTagonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- August 2, 2037
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  Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
- August 2, 2037
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  Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
Formulation for inhibiting formation of 5-HTagonists and methods of using same
Patent 10603290*PE
Issued: March 31, 2020
Inventor(s): Farr Stephen J. & Boyd Brooks
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HTagonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- February 2, 2038
Fenfluramine compositions and methods of preparing the same
Patent 10,947,183
Issued: March 16, 2021
Inventor(s): Londesbrough Derek J. & Andersen Marc W.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Methods of preparing a fenfluramine active pharmaceutical ingredient are provided. Aspects of the method include (a) hydrolyzing a 2-(3-(trifluoromethyl)phenyl)acetonitrile composition to produce a 2-(3-(trifluoromethyl)phenyl)acetic acid composition; (b) reacting the 2-(3-(trifluoromethyl)phenyl)acetic acid composition with acetic anhydride and a catalyst to produce a 1-(3-(trifluoromethyl)phenyl)propan-2-one composition; and
Patent expiration dates:
- December 20, 2036
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  Drug substance
  ✓
  Drug product
Fenfluramine compositions and methods of preparing the same
Patent 10947183*PE
Issued: March 16, 2021
Inventor(s): Londesbrough Derek J. & Andersen Marc W.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Methods of preparing a fenfluramine active pharmaceutical ingredient are provided. Aspects of the method include (a) hydrolyzing a 2-(3-(trifluoromethyl)phenyl)acetonitrile composition to produce a 2-(3-(trifluoromethyl)phenyl)acetic acid composition; (b) reacting the 2-(3-(trifluoromethyl)phenyl)acetic acid composition with acetic anhydride and a catalyst to produce a 1-(3-(trifluoromethyl)phenyl)propan-2-one composition; and
Patent expiration dates:
- June 20, 2037
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent 11,040,018
Issued: June 22, 2021
Inventor(s): Farr Stephen J. & Boyd Brooks
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HTagonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
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
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  Patent use: USE IN COMBINATION WITH CANNABIDIOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent 11040018*PE
Issued: June 22, 2021
Inventor(s): Farr Stephen J. & Boyd Brooks
Assignee(s): ZOGENIX INTERNATIONAL LIMITED
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HTagonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- February 2, 2038
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent 11,406,606
Issued: August 9, 2022
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- August 2, 2037
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  Patent use: USE OF FENFLURAMINE AT REDUCED AMOUNTS WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME
- August 2, 2037
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  Patent use: USE OF FENFLURAMINE AT REDUCED AMOUNTS WITH STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX GASTAUT SYNDROME
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent 11406606*PE
Issued: August 9, 2022
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- February 2, 2038
Formulation for inhibiting formation of 5-HT.SUB.2B .agonists and methods of using same
Patent 11,759,440
Issued: September 19, 2023
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- August 2, 2037
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  Patent use: METHOD OF REDUCING OR AMELIORATING SEIZURES IN A PATIENT BY ADMINISTERING A LIQUID FORMULATION OF FENFLURAMINE WITH STIRIPENTOL THEREBY MODULATING DOWN THE FORMATION OF NORFENFLURAMINE AND RESULTING IN HIGHER LEVELS OF FENFLURAMINE
Formulation for inhibiting formation of 5-HT.SUB.2B .agonists and methods of using same
Patent 11759440*PE
Issued: September 19, 2023
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- February 2, 2038
Formulation for inhibiting formation of 5-HT.SUB.2B .agonists and methods of using same
Patent 11,786,487
Issued: October 17, 2023
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- August 2, 2037
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  Patent use: METHOD OF TREATING SEIZURES IN A PATIENT BY ADMINISTERING A LIQUID FORMULATION OF FENFLURAMINE OR ITS SALTS PLUS STIRIPENTOL THEREBY REDUCING NORFENFLURAMINE FORMATION WHILE INCREASING THE FENFLURAMINE LEVEL. PATIENTS CAN HAVE E.G. DRAVET OR LGS
Formulation for inhibiting formation of 5-HT.SUB.2B .agonists and methods of using same
Patent 11786487*PE
Issued: October 17, 2023
Inventor(s): Farr; Stephen J. et al.
Assignee(s): ZOGENIX INTERNATIONAL LIMITED (Berkshire, GB)
Drug combinations and their use are disclosed. A first drug is administered in combination with a second drug. The first drug such as fenfluramine is characterized by the formation of a metabolite including 5-HT.sub.2B agonists such as norfenfluramine with known adverse side effects. The second drug is in the form of a CYP inhibitor such as cannabidiol which modulates the formation of metabolite down thereby making the first drug safer.
Patent expiration dates:
- February 2, 2038
Method for the treatment of Dravet Syndrome
Patent 12,097,206
Issued: September 24, 2024
Inventor(s): Ceulemens; Berten et al.
Assignee(s): Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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
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  Patent use: A METHOD OF ADJUNCTIVE TREATING, PREVENTING AND/OR AMELIORATING SEIZURES IN A PERSON WITH DRAVET SYNDROME COMPRISING ADMINISTERING FENFLURAMINE OR A SALT THEREOF IN A DOSE OF 0.2 MG/KG/DAY TO 0.5/MG/KG/DAY AND DOSES OF STIRIPENTOL AND CLOBAZAM
Method for the treatment of Dravet Syndrome
Patent 12097206*PE
Issued: September 24, 2024
Inventor(s): Ceulemens; Berten et al.
Assignee(s): Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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:
- November 3, 2033
Method for the treatment of dravet syndrome
Patent 9,549,909
Issued: January 24, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): The Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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
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  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 9549909*PED
Issued: January 24, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): The Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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:
- November 3, 2033
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  Pediatric exclusivity
Method for the treatment of Dravet syndrome
Patent 9,603,814
Issued: March 28, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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 9603814*PED
Issued: March 28, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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:
- November 3, 2033
  ✓
  Pediatric exclusivity
Method for the treatment of Dravet syndrome
Patent 9,603,815
Issued: March 28, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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 9603815*PED
Issued: March 28, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): THE KATHOLIEKE UNIVERSITEIT LEUVEN (Leuven, BE); UNIVERSITY HOSPITAL ANTWERP (Edegem, BE)
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:
- November 3, 2033
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  Pediatric exclusivity
Method for the treatment of Dravet Syndrome
Patent 9,610,260
Issued: April 4, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): The Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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
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  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 9610260*PED
Issued: April 4, 2017
Inventor(s): Ceulemens; Berten et al.
Assignee(s): The Katholieke Universiteit Leuven (Leuven, BE); University Hospital Antwerp (Edegem, BE)
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:
- 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:
- 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

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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.

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Pregnancy & Lactation Risk data available

CSA Schedule* Some potential for abuse 4

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Pill medicine is Fintepla 2.2 mg/mL oral solution — Fintepla 2.2 mg/mL oral solution