ORLAAM
LOE Approachinglevomethadyl acetate hydrochloride
NDAORALCONCENTRATEPriority Review
Approved
Jul 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLAAM (levomethadyl acetate hydrochloride) is an oral concentrate for the treatment of opioid addiction. It is a long-acting synthetic opioid agonist that requires thrice-weekly dosing for maintenance therapy. The active levoisomer provides sustained opioid receptor agonism with extended duration of action compared to methadone.
LOE Approaching
Product approaching loss of exclusivity with minimal commercial activity; limited team expansion expected and career growth tied to niche addiction medicine expertise.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on ORLAAM offers limited career growth opportunity due to LOE approaching and minimal commercial momentum. This role best suits professionals seeking specialized experience in addiction medicine or regulatory affairs within a sunset product environment.
Brand ManagerCommercial Operations Analyst
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.