NDAORALTABLET, FOR SUSPENSION6 Generics Approved
Approved
Mar 1973
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Data completeness
1/8 — Limited
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Methadone hydrochloride is a synthetic opioid agonist available as an oral tablet for suspension formulation. It is primarily used for pain management and opioid use disorder treatment, functioning as a long-acting mu-opioid receptor agonist that reduces withdrawal symptoms and cravings. The drug has been a cornerstone of addiction medicine since its FDA approval in 1973.
LOE Approaching
As a mature, generic-vulnerable product approaching loss of exclusivity, commercial teams will focus on retention and cost management rather than market expansion.
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 methadone offers stability and regulatory expertise in a legacy product, but limited growth opportunity as the product enters LOE. Ideal for professionals focused on lifecycle management, market access strategy, or risk mitigation in a complex therapeutic area.
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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.