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Last Updated: June 14, 2024

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FIRDAPSE Drug Patent Profile


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When do Firdapse patents expire, and when can generic versions of Firdapse launch?

Firdapse is a drug marketed by Catalyst Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in two countries.

The generic ingredient in FIRDAPSE is amifampridine phosphate. One supplier is listed for this compound. Additional details are available on the amifampridine phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Firdapse

Firdapse was eligible for patent challenges on November 28, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for FIRDAPSE
International Patents:3
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 170
Clinical Trials: 3
Drug Prices: Drug price information for FIRDAPSE
What excipients (inactive ingredients) are in FIRDAPSE?FIRDAPSE excipients list
DailyMed Link:FIRDAPSE at DailyMed
Drug patent expirations by year for FIRDAPSE
Drug Prices for FIRDAPSE

See drug prices for FIRDAPSE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FIRDAPSE
Generic Entry Date for FIRDAPSE*:
Constraining patent/regulatory exclusivity:
NDA:
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 FIRDAPSE

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

SponsorPhase
Wake Forest University Health SciencesPhase 1
Augusta UniversityPhase 2
Centre Hospitalier Universitaire, AmiensPhase 2/Phase 3

See all FIRDAPSE clinical trials

Pharmacology for FIRDAPSE
Paragraph IV (Patent) Challenges for FIRDAPSE
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 FIRDAPSE

FIRDAPSE is protected by six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FIRDAPSE is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FIRDAPSE

Determining degradation of 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of administering 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE

Methods of administering 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE

Methods of administering 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE

Methods of administering 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE

Methods of administering 3,4-diaminopyridine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE

FDA Regulatory Exclusivity protecting FIRDAPSE

TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS)
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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
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

International Patents for FIRDAPSE

See the table below for patents covering FIRDAPSE around the world.

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