NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIRTURO (bedaquiline fumarate) is an oral small-molecule tablet approved in 2012 for treating drug-resistant tuberculosis (MDR-TB and XDR-TB). It is a mycobacterial ATP synthase inhibitor that disrupts bacterial energy production, offering a novel mechanism in TB therapy.
$3MPart D
Peak2.9 years to LOEModest Part D utilization ($3M spending, 645 claims in 2023) suggests a niche specialist product with stable but limited commercial opportunity.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
LOE in ~3 years — strategic planning for patent cliff underway
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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.