Last Updated: October 25, 2026

Amifampridine - Generic Drug Details

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Summary for amifampridine

US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	9
Patent Applications:	5,685
What excipients (inactive ingredients) are in amifampridine?	amifampridine excipients list
DailyMed Link:	amifampridine at DailyMed

Recent Clinical Trials for amifampridine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 1
Augusta University	Phase 2
Catalyst Pharmaceuticals, Inc.	Phase 2

See all amifampridine clinical trials

Generic filers with tentative approvals for AMIFAMPRIDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for amifampridine

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for amifampridine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	11,268,128	⤷ Start Trial				⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	10,793,893	⤷ Start Trial				⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	11,060,128	⤷ Start Trial				⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	11,274,331	⤷ Start Trial				⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	10,626,088	⤷ Start Trial	Y			⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	11,274,332	⤷ Start Trial				⤷ Start Trial
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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