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Last Updated: September 27, 2020

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Amifampridine - Generic Drug Details

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What are the generic drug sources for amifampridine and what is the scope of patent protection?

Amifampridine is the generic ingredient in two branded drugs marketed by Jacobus Pharm Co Inc and Catalyst Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for amifampridine
US Patents:0
Suppliers / Packagers: 1
Bulk Api Vendors: 155
Clinical Trials: 8
Patent Applications: 1,624
DailyMed Link:amifampridine at DailyMed
Recent Clinical Trials for amifampridine

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

Catalyst Pharmaceuticals, Inc.Phase 2
Catalyst Pharmaceuticals, Inc.Phase 3
Catalyst Pharmaceuticals, Inc.N/A

See all amifampridine clinical trials

Generic filers with tentative approvals for AMIFAMPRIDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;ORAL

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

Pharmacology for amifampridine

US Patents and Regulatory Information for amifampridine

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   Start Trial   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
Jacobus Pharm Co Inc RUZURGI amifampridine TABLET;ORAL 209321-001 May 6, 2019 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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