Amifampridine phosphate - Generic Drug Details

What are the generic drug sources for amifampridine phosphate and what is the scope of freedom to operate?

Amifampridine phosphate is the generic ingredient in one branded drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amifampridine phosphate has three patent family members in two countries.

One supplier is listed for this compound.

Summary for amifampridine phosphate

International Patents:	3
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	8
Patent Applications:	89
What excipients (inactive ingredients) are in amifampridine phosphate?	amifampridine phosphate excipients list
DailyMed Link:	amifampridine phosphate at DailyMed

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

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 phosphate

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

Sponsor	Phase
Catalyst Pharmaceuticals, Inc.	Phase 2
Catalyst Pharmaceuticals, Inc.	Phase 3
Catalyst Pharmaceuticals, Inc.

See all amifampridine phosphate clinical trials

Pharmacology for amifampridine phosphate

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for amifampridine phosphate

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

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

Paragraph IV (Patent) Challenges for AMIFAMPRIDINE PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRDAPSE	Tablets	amifampridine phosphate	10 mg	208078	3	2022-11-28

US Patents and Regulatory Information for amifampridine phosphate

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
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes			Y
Catalyst Pharms	FIRDAPSE	amifampridine phosphate	TABLET;ORAL	208078-001	Nov 28, 2018		RX	Yes	Yes

International Patents for amifampridine phosphate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003708
Canada	2840591	METHODES D'ADMINISTRATION DE 3,4-DIAMINOPYRIDINE (METHODS OF ADMINISTERING 3,4-DIAMINOPYRIDINE)
World Intellectual Property Organization (WIPO)	2017214504