NDAORALTABLET, FOR SUSPENSION5 Generics Approved
Approved
Mar 1973
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Data completeness
1/8 — Limited
Drug data last refreshed 15h 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 opioid use disorder maintenance treatment and chronic pain management. The drug works by binding to mu-opioid receptors in the central nervous system to prevent withdrawal symptoms and reduce cravings.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (60/100), signaling potential team consolidation or transition planning.
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 exposure to payer negotiations, regulatory maintenance, and managed access strategies rather than commercial growth. Career development focuses on operational efficiency, compliance, and reimbursement defense in a mature, competitive market.
Regulatory Affairs SpecialistReimbursement Manager
Worked on METHADONE HYDROCHLORIDE at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.