NDAORALTABLETPriority Review
Approved
Dec 2012
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIRTURO (bedaquiline fumarate) is an oral small-molecule ATP synthase inhibitor approved in 2012 for treatment-resistant tuberculosis (TB). It represents a novel mechanism of action targeting mycobacterial energy metabolism, offering a critical option for multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB patients who have exhausted standard regimens.
$0.003BPart D
LOE Approaching2.6 years to LOEWith lifecycle approaching LOE in 2.7 years and minimal Part D claims (645 in 2023), this is a niche, specialty product with limited commercial momentum and likely a small, focused team.
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
Worked on SIRTURO at Enthera Pharmaceuticals? 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.