NDAORALSUSPENSION
Approved
May 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — Partial
CORTEF (hydrocortisone cypionate) by Pfizer is clinical pharmacology glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Approved for dermatomyositis, temporal arteritis, polymyositis and 14 more indications. First approved in 1955.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTEF (hydrocortisone cypionate) is an oral glucocorticoid suspension approved in 1955 for replacement therapy in adrenocortical deficiency and anti-inflammatory treatment across multiple organ systems. It treats conditions including systemic lupus erythematosus, rheumatoid arthritis, asthma, ulcerative colitis, and severe allergic reactions by modulating immune response and reducing inflammation.
$0.683MPart D
LOE ApproachingStable
Product approaching loss of exclusivity with modest Part D spending of $683K in 2023; brand team likely in maintenance/transition mode with limited headcount expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement…
Indications (17)
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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.