NDAINTRAVENOUSPOWDER
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
KIMYRSA (oritavancin diphosphate) by CorMedix is 12. Approved for skin structure infections (absssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-susceptible, methicillin-resistant isolates), streptococcus pyogenes and 3 more indications. First approved in 2021.
Drug data last refreshed 10h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KIMYRSA (oritavancin diphosphate) is a semi-synthetic lipoglycopeptide antibacterial agent administered as a single 1,200 mg IV infusion over 1 hour. It treats acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive organisms including S. aureus, S. pyogenes, S. agalactiae, and S. dysgalactiae. Oritavancin's mechanism correlates with AUC/MIC ratio, achieving rapid exposure with a long terminal half-life (~245 hours) enabling single-dose therapy.
$1MPart D
Peak8.7 years to LOEEarly-stage peak commercial trajectory with modest Part D penetration (198 claims in 2023) suggests growing market adoption and opportunities for field force expansion and patient access roles.
Mechanism of Action
12.1 Mechanism of Action Oritavancin is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antimicrobial activity of oritavancin appears to correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) based on animal models of infection.…
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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.