Prescription medicine
Amifampridine Brand names: Firdapse
Amifampridine (Firdapse) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the amifampridine FDA label on DailyMed (effective April 16, 2026, Catalyst Pharmaceuticals, Inc.); the NDA 208078 record on Drugs@FDA; every amifampridine label on DailyMed.
Highlights of the record
FDA label of April 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.
Forms and strengths
- 10 mg
Tablet.
On the market
- Earliest approval on file
- November 28, 2018 Firdapse, Catalyst Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 25, 2037 Firdapse tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,868 through July 30, 2026
What is amifampridine used for?
From the label: indications and usageFIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.
FDA pharmacologic class: Potassium Channel Blocker.
Source: FDA drug label (Firdapse), Catalyst Pharmaceuticals, Inc., effective April 16, 2026 (SPL set f015fe60-3128-4a43-8c31-19fc6b5def3f), via openFDA; the full label on DailyMed
What does the patient leaflet for amifampridine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FIRDAPSE?FIRDAPSE can cause seizures. You could have a seizure even if you never had a seizure before. Do not take FIRDAPSE if you have ever had a seizure. Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.
From the patient leaflet: How should I store FIRDAPSE?Store FIRDAPSE tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Safely throw away FIRDAPSE tablets that are out of date or no longer needed. Store FIRDAPSE prepared oral suspension in the refrigerator between 36°F to 46°F (2°C to 8°C) between doses for up to 24 hours. Safely throw away unused FIRDAPSE oral suspension after 24 hours. Keep FIRDAPSE and all medicines out of the reach of children. General Information about the safe and effective use of FIRDAPSE Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FIRDAPSE for a condition for which it was not prescribed. Do not give FIRDAPSE to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. […]
Source: FDA drug label (Firdapse), Catalyst Pharmaceuticals, Inc., effective April 16, 2026 (SPL set f015fe60-3128-4a43-8c31-19fc6b5def3f), via openFDA; the full label on DailyMed
Is there a generic for amifampridine (Firdapse)?
No generic amifampridine is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 6 patents for Firdapse tablets, the last expiring on February 25, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for amifampridine?
The FDA Adverse Event Reporting System holds 2,868 reports that list amifampridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 759 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other potassium channel blockers
- the pharmacologic class, with prices and generics
- Amifampridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other