NDAINTRAVENOUSPOWDERPriority Review
Approved
Sep 2003
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
CUBICIN (daptomycin) by Merck & Co. is 12. Approved for bacteremia, soft tissue infections, skin infections and 11 more indications. First approved in 2003.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CUBICIN (daptomycin) is a cyclic lipopeptide antibiotic administered intravenously that treats serious gram-positive bacterial infections including bacteremia, endocarditis, and skin/soft tissue infections. It works by disrupting bacterial cell membrane integrity and correlates with AUC/MIC pharmacodynamic parameters for clinical efficacy.
Peak4.6 years to LOE
Product remains in peak lifecycle stage at 21 years post-approval with 4.6 years of patent protection remaining; expect stable team size but increasing focus on LOE transition planning.
Mechanism of Action
12.1 Mechanism of Action Daptomycin is an antibacterial drug [see ]. 12.2 Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain…
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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.