CELESTONE
LOE ApproachingNDAORALSYRUP
Approved
Apr 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CELESTONE by Merck & Co. is clinical pharmacology glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Approved for dermatomyositis, polymyositis, systemic lupus erythematosus. First approved in 1964.
Drug data last refreshed 23h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELESTONE is an oral syrup formulation of betamethasone, a synthetic glucocorticoid derived from prednisolone with enhanced anti-inflammatory potency. It is indicated for autoimmune and inflammatory conditions including dermatomyositis, polymyositis, and systemic lupus erythematosus. Betamethasone's 16β-methyl group enhances anti-inflammatory action while reducing sodium and water retention typical of other corticosteroids.
LOE Approaching
As a legacy corticosteroid approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely consolidating around lifecycle management and generic transition planning rather than growth initiatives.
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 (3)
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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.