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Last Updated: June 16, 2021

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FIRDAPSE Drug 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 is one patent protecting this drug.

This drug has two 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 will be eligible for patent challenges on November 28, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 28, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for FIRDAPSE
International Patents:2
US Patents:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 162
Clinical Trials: 1
Patent Applications: 2,413
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 Generic Entry Opportunity Date for FIRDAPSE
Generic Entry Date for FIRDAPSE*:
Constraining patent/regulatory exclusivity:

*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

Centre Hospitalier Universitaire, AmiensPhase 2/Phase 3

See all FIRDAPSE clinical trials

Pharmacology for FIRDAPSE

US Patents and Regulatory Information for FIRDAPSE

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   Get Started Free   Get Started Free   Get Started Free
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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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Serving leading biopharmaceutical companies globally:

Harvard Business School

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.