DIFICID

Peak

fidaxomicin

NDAORALFOR SUSPENSIONPriority Review
Approved
Jan 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17

Mechanism of Action

12.1 Mechanism of Action Fidaxomicin is an antibacterial drug [see ] . 12.2 Pharmacodynamics Fidaxomicin acts locally in the gastrointestinal tract on C. difficile . In a dose-ranging trial (N=48) of fidaxomicin using 50 mg, 100 mg, and 200 mg twice daily for 10 days, a dose-response relationship…

Pharmacologic Class:

Macrolide Antibacterial

Clinical Trials (5)

NCT04070352N/AWithdrawn

Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

Started Aug 2019
0
Clostridium Difficile Infection (CDI)
NCT02692651Phase 4Completed

A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

Started May 2017
144 enrolled
Clostridium Difficile Infection (CDI)
NCT02437591Phase 4Completed

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

Started Aug 2015
25 enrolled
Inflammatory Bowel Disease (IBD)Clostridium Difficile Infection (CDI)
NCT02218372Phase 3Completed

A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Started Jan 2015
148 enrolled
Clostridium Difficile-associated Diarrhea (CDAD)
NCT02461901N/ACompleted

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?

Started Jan 2015
203 enrolled
Clostridium Difficile Infection

Loss of Exclusivity

LOE Date
Nov 28, 2034
106 months away
Patent Expiry
Nov 28, 2034
Exclusivity Expiry
Jan 24, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
7906489
Mar 4, 2027
U-2741
8859510
Jul 31, 2027
U-2741
7863249
Jul 31, 2027
Product
7378508
Jul 31, 2027
SubstanceProduct
7906489*PED
Sep 4, 2027