NDAORALCAPSULE
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
VANCOCIN HYDROCHLORIDE (vancomycin hydrochloride) by ANI Pharmaceuticals is clinical pharmacology vancomycin is poorly absorbed after oral administration. First approved in 1986.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VANCOCIN HYDROCHLORIDE is an oral vancomycin formulation, a bactericidal antibiotic that inhibits bacterial cell-wall biosynthesis and alters cell-membrane permeability. It is indicated for treating serious gram-positive infections, particularly Clostridioides difficile infections and methicillin-resistant Staphylococcus aureus (MRSA) when oral therapy is appropriate. The drug has poor systemic absorption when taken orally but achieves high local concentrations in the GI tract.
LOE Approaching
This product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting the commercial team is likely focused on lifecycle management and generic transition strategies rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Vancomycin is poorly absorbed after oral administration. In subjects with normal kidney function, multiple intravenous dosing of 1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mcg/mL immediately after the completion…
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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.