NDAINJECTIONINJECTABLEPriority Review
Approved
Jun 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
CORTONE (cortisone acetate) by Merck & Co. is clinical pharmacology: naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Approved for prostate cancer, chronic kidney disease, atopic dermatitis and 1 more indications. First approved in 1950.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTONE (cortisone acetate) is a naturally occurring glucocorticoid administered by injection for replacement therapy in adrenocortical deficiency and potent anti-inflammatory effects across multiple organ systems. It modulates immune responses and produces profound metabolic effects, with approved indications spanning prostate cancer, chronic kidney disease, atopic dermatitis, and hepatic impairment. The drug has been a foundational therapy since 1950, though it now operates in a landscape dominated by newer mechanistic alternatives.
LOE Approaching
As LOE approaches with no patent protection data available, the brand team is likely in transition mode focused on lifecycle management and potential portfolio repositioning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY: Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. They are also used for their potent anti-inflammatory effects in disorders of many organ…
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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.