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Last Updated: December 12, 2024

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amifampridine

Generic Entry Date for amifampridine^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN PATIENTS 6 TO LESS THAN 17 YEARS OF AGE Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
⤷ Sign Up	⤷ Sign Up	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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.