NDAINJECTIONINJECTABLE
Approved
Jun 1954
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
PURIFIED CORTROPHIN GEL (repository corticotropin) by ANI Pharmaceuticals is unknown. Approved for exacerbations of multiple sclerosis in adults, acute exacerbations of multiple sclerosis in adults, multiple sclerosis and 3 more indications. First approved in 1954.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Purified Cortrophin Gel is a repository corticotropin (ACTH) injection that stimulates the adrenal cortex to produce cortisol and other steroid hormones. It is indicated for acute exacerbations of multiple sclerosis and rheumatoid arthritis. The mechanism of action involves binding to melanocortin receptors and stimulating adrenal hormone release via cyclic AMP pathways, though the precise mechanism remains incompletely understood.
Peak17.3 years to LOE
The product is in peak commercial stage with patent protection through 2043, suggesting a stable mid-sized franchise with sustained team investment.
Mechanism of Action
unknown. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Prolonged administration of large doses of Acthar Gel induces hyperplasia and hypertrophy of the adrenal cortex and continuous high…
Pharmacologic Class:
Adrenocorticotropic Hormone
Indications (4)
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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.