NDAORALFOR SUSPENSIONPriority Review
Approved
Jan 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
5/8 — Partial
Priority Review
DIFICID (fidaxomicin) by Merck & Co. is 12. First approved in 2020.
Drug data last refreshed 23h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFICID (fidaxomicin) is an oral macrolide antibacterial indicated for Clostridioides difficile infection (CDI), acting locally in the gastrointestinal tract. The drug has minimal systemic absorption and works by inhibiting bacterial RNA polymerase, with its active metabolite OP-1118 formed via ester hydrolysis. Fidaxomicin demonstrates a dose-response relationship with efficacy at doses of 50-200 mg twice daily for 10 days.
Peak8.2 years to LOE
Product is in peak commercial lifecycle stage with 8.2 years of patent exclusivity remaining; team size and growth status unknown pending market data.
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…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.