CORTISPORIN
LOE Approachingbacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
NDATOPICALOINTMENT
Approved
Mar 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CORTISPORIN (bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate) by Monarch Therapeutics is clinical pharmacology colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Approved for superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics. First approved in 1957.
Drug data last refreshed 14h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTISPORIN is a fixed-dose topical ointment combining bacitracin zinc, hydrocortisone, neomycin sulfate, and polymyxin B sulfate for treatment of superficial bacterial infections of the external auditory canal. The dual antibiotic components provide bactericidal activity against gram-positive and gram-negative pathogens, while hydrocortisone reduces inflammation and pruritus. This combination approach addresses both infection and inflammatory symptoms in otologic conditions.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential downsizing or redeployment of brand team resources within the next 2-3 years.
Mechanism of Action
CLINICAL PHARMACOLOGY Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a…
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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.