Generic Firdapse Availability
Last updated on Nov 6, 2024.
Firdapse is a brand name of amifampridine, approved by the FDA in the following formulation(s):
FIRDAPSE (amifampridine phosphate - tablet;oral)
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Manufacturer: CATALYST PHARMS
Approval date: November 28, 2018
Strength(s): EQ 10MG BASE [RLD]
Has a generic version of Firdapse been approved?
No. There is currently no therapeutically equivalent version of Firdapse available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Firdapse. 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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Determining degradation of 3,4-diaminopyridine
Patent 10,626,088
Issued: April 21, 2020
Inventor(s): Schiehser Guy Alan & Shah Rajendra & Zhao Wenyi
Assignee(s): JACOBUS PHARMACEUTICAL COMPANY, INC.The present invention relates to methods of determining the purity of a sample of 3,4-diaminopyridine comprising determining the presence, absence, or amount of a dimer of 3,4-diaminopyridine or a dimer of 3,4-diaminopyridine in the form of a salt, solvate or complex or a combination thereof. The invention also relates to methods of detecting and quantitating degradation in a sample of 3,4-diaminopyridine. Dimers of 3,4-diaminopyridine and methods of making and isolating the same are also provided.
Patent expiration dates:
- February 25, 2037✓
- February 25, 2037
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Methods of administering 3,4-diaminopyridine
Patent 10,793,893
Issued: October 6, 2020
Inventor(s): Garovoy Marvin R. & Haroldsen Peter E. & Musson Donald G.
Assignee(s): SERB SAProvided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Patent expiration dates:
- May 26, 2034✓
- May 26, 2034
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Methods of administering 3,4-diaminopyridine
Patent 11,060,128
Issued: July 13, 2021
Inventor(s): Garovoy Marvin R. & Haroldsen Peter E. & Musson Donald G.
Assignee(s): SERB SAProvided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Patent expiration dates:
- June 29, 2032✓
- June 29, 2032
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Methods of administering 3,4-diaminopyridine
Patent 11,268,128
Issued: March 8, 2022
Inventor(s): Garovoy Marvin R. & Haroldsen Peter E. & Musson Donald G.
Assignee(s): SERB SAProvided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Patent expiration dates:
- June 29, 2032✓
- June 29, 2032
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Methods of administering 3,4-diaminopyridine
Patent 11,274,331
Issued: March 15, 2022
Inventor(s): Garovoy Marvin R. & Haroldsen Peter E. & Musson Donald G.
Assignee(s): SERB SAProvided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Patent expiration dates:
- June 29, 2032✓
- June 29, 2032
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Methods of administering 3,4-diaminopyridine
Patent 11,274,332
Issued: March 15, 2022
Inventor(s): Garovoy Marvin R. & Haroldsen Peter E. & Musson Donald G.
Assignee(s): SERB SAProvided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Patent expiration dates:
- June 29, 2032✓
- June 29, 2032
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:
- September 29, 2025 - NEW PATIENT POPULATION
- November 28, 2025 - TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS)
More about Firdapse (amifampridine)
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- Drug class: cholinergic muscle stimulants
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Glossary
Term | Definition |
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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.