NDAORALCONCENTRATE
Approved
Mar 1973
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
METHADOSE (methadone hydrochloride) by Hikma is mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and organs composed of smooth muscle. First approved in 1973.
Drug data last refreshed 2m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
METHADOSE is a synthetic opioid agonist approved since 1973 for oral use as a concentrate formulation. It works primarily as a mu-opioid receptor agonist with secondary NMDA receptor antagonist activity, producing effects qualitatively similar to morphine. The drug is used in opioid use disorder treatment and pain management, with a slower withdrawal onset and more prolonged course than morphine.
LOE Approaching
Product faces approaching loss of exclusivity with moderate competitive pressure (30%), signaling reduced team expansion and focus on cost management and market stabilization.
Mechanism of Action
mu-agonist; a synthetic opioid with multiple actions qualitatively similar to those of morphine, the most prominent of which involves the central nervous system and organs composed of smooth muscle. The methadone withdrawal syndrome, although qualitatively similar to that of morphine, differs in…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
METHADOSE represents a stable, mature asset with minimal current job growth, making it a consolidation or downstream role rather than a high-growth career opportunity. Professionals joining this team should expect focus on market defense, regulatory compliance, and operational efficiency rather than expansion.
Brand Manager
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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.