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Firdapse

(Amifampridine)

Small molecule

CCatalyst Biosciences

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

OnabotulinumtoxinA1 trial

Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Completed·WWake Forest University Health Sciences·Phase 1·NCT05769478·21 enrolled

Botox1 trial

Firdapse for Post-BOTOX Vocal Weakness

Completed·—·Phase 2·NCT05123053·18 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 28, 2018

FIRDAPSE

NDA NDA208078

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Amifampridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amifampridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208078). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Firdapse. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Catalyst Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: CCatalyst Biosciences

Patent Landscape[4]

Patent Cliff

Jun 29, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11274332Jun 29, 2032

11274331Jun 29, 2032

11268128Jun 29, 2032

11060128Jun 29, 2032

10793893May 26, 2034

1 more patents

10626088Feb 25, 2037

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