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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

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

Generic Entry Date for FIRDAPSE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208078 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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 1
Augusta University	Phase 2
Centre Hospitalier Universitaire, Amiens	Phase 2/Phase 3

See all FIRDAPSE clinical trials

Pharmacology for FIRDAPSE

Drug Class	Potassium Channel Blocker
Mechanism of Action	Potassium Channel Antagonists

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

FDA Regulatory Exclusivity protecting FIRDAPSE

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

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Glossary

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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				⤷ 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	Y			⤷ 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.

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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