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Last Updated: January 27, 2023

Amifampridine phosphate - Generic Drug Details


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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: 14
Clinical Trials: 8
Patent Applications: 97
What excipients (inactive ingredients) are in amifampridine phosphate?amifampridine phosphate excipients list
DailyMed Link:amifampridine phosphate at DailyMed
Recent Clinical Trials for amifampridine phosphate

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

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

See all amifampridine phosphate clinical trials

Pharmacology for amifampridine phosphate

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for amifampridine phosphate

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

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