NDAINJECTIONINJECTABLE
Approved
Aug 1947
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
METHADONE HYDROCHLORIDE (methadone hydrochloride) by Viatris (2) is mechanism of action methadone hydrochloride is a mu-agonist; a synthetic opioid analgesic with multiple actions qualitatively similar to those of morphine, the most prominent of which involve the central nervous system and organs composed of smooth muscle. First approved in 1947.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Methadone hydrochloride is a synthetic mu-agonist opioid analgesic administered via injection, primarily indicated for opioid addiction maintenance and detoxification as well as analgesia. The drug works through mu-receptor agonism with additional NMDA receptor antagonist properties, producing a slower onset and more prolonged abstinence syndrome compared to morphine.
LOE Approaching
As a mature, near-LOE product with moderate competitive pressure (30), the commercial team is likely focused on cost management and market defense rather than expansion.
Mechanism of Action
Mechanism of Action Methadone hydrochloride is a mu-agonist; a synthetic opioid analgesic with multiple actions qualitatively similar to those of morphine, the most prominent of which involve the central nervous system and organs composed of smooth muscle. The principal therapeutic uses for…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on methadone hydrochloride offers exposure to managed markets, REMS complexity, and controlled substance compliance—critical skills in addiction medicine. However, the LOE-approaching lifecycle limits growth opportunities and suggests roles focused on market defense, cost optimization, and regulatory stewardship rather than expansion.
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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.