NDAINJECTIONINJECTABLE
Approved
Oct 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
H.P. ACTHAR 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 2010.
Drug data last refreshed 15h ago · AI intelligence enriched 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
H.P. ACTHAR GEL is a repository corticotropin injection that stimulates the adrenal cortex to produce cortisol and other corticosteroids. It is indicated for acute exacerbations of multiple sclerosis and rheumatoid arthritis. The precise mechanism remains incompletely understood, though it binds melanocortin receptors and operates via cyclic AMP-mediated pathways on the adrenal gland.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30); team size and growth expectations likely constrained.
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…
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.