NDAORALTABLETPriority Review
Approved
May 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
19
Data completeness
6/8 — Strong
Priority Review
DIFICID (fidaxomicin) by Merck & Co. is 12. First approved in 2011.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFICID (fidaxomicin) is an oral macrolide antibacterial approved in 2011 for Clostridioides difficile infection (CDI), acting locally in the gastrointestinal tract with minimal systemic absorption. It works through bacterial RNA polymerase inhibition, with a main microbiologically active metabolite OP-1118 formed via hydrolysis. The drug demonstrates dose-dependent efficacy and is confined primarily to the GI tract where C. difficile resides.
$0.127BPart D
LOE Approaching1.4 years to LOEProduct approaching loss of exclusivity in 1.4 years; brand teams should focus on retention strategies and managed generic transition planning.
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…
Worked on DIFICID at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.