NDAORALCAPSULEPriority Review
Approved
May 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ACCUTANE (isotretinoin) by Roche is clinical pharmacology isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0. Approved for acne vulgaris. First approved in 1982.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Accutane (isotretinoin) is an oral retinoid that inhibits sebaceous gland function and keratinization, used primarily for severe nodular acne. The drug works by reducing sebum secretion and sebaceous gland size through unclear mechanisms. It is also being investigated for off-label use in neuroblastoma, cervical dysplasia, glioblastoma, and other malignancies.
$0.083MPart D
LOE ApproachingThe product is approaching loss of exclusivity with minimal Part D utilization (424 claims in 2023), signaling a mature, contracted brand with limited growth opportunities and likely a small, maintenance-focused team.
Mechanism of Action
CLINICAL PHARMACOLOGY Isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1 mg/kg/day (see ), inhibits sebaceous gland function and keratinization. The exact mechanism of action of isotretinoin is unknown. Nodular Acne Clinical improvement in nodular acne patients…
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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.