CORTISPORIN
LOE Approachinghydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
NDATOPICALCREAM
Approved
Apr 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CORTISPORIN (hydrocortisone acetate; 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 1963.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTISPORIN is a fixed-dose topical cream combining hydrocortisone acetate (corticosteroid), neomycin sulfate (aminoglycoside antibiotic), and polymyxin B sulfate (polypeptide antibiotic) for treatment of superficial bacterial infections of the external auditory canal. The formulation works by disrupting bacterial cell membranes, inhibiting protein synthesis, and suppressing inflammatory response simultaneously. It is indicated for infections caused by susceptible gram-positive and gram-negative organisms including Staphylococcus aureus and Pseudomonas aeruginosa.
LOE Approaching
As a legacy product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely focused on defending market share rather than growth, suggesting smaller dedicated headcount and emphasis on managed care and market access roles.
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.