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Last Updated: July 12, 2020

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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.

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.

Drug patent expirations by year for FIRDAPSE
Drug Prices for FIRDAPSE

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Generic Entry Opportunity Date for FIRDAPSE
Generic Entry Date for FIRDAPSE*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN ADULTS
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

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SponsorPhase
Centre Hospitalier Universitaire, AmiensPhase 2/Phase 3

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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   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
>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:

Baxter
Merck
Moodys
Dow
AstraZeneca
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.