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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFICID (fidaxomicin) is an oral macrolide antibacterial indicated for Clostridioides difficile infection (CDI). It acts locally in the gastrointestinal tract with minimal systemic absorption, exerting bactericidal activity through inhibition of bacterial RNA polymerase. The drug is metabolized to its active metabolite OP-1118, which contributes to therapeutic efficacy.
$0.127BPart D
LOE Approaching1.6 years to LOEProduct approaching loss of exclusivity in 1.6 years with stable Part D spending of $127M, indicating a mature franchise requiring transition planning and potential cost management strategies.
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.