NDAFOR RX COMPOUNDINGPOWDER
Approved
Dec 1947
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
METHADONE HYDROCHLORIDE (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 1947.
Drug data last refreshed 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Methadone hydrochloride is a synthetic mu-agonist opioid approved in 1947 as a powder for RX compounding. It is indicated for pain management and opioid addiction treatment (detoxification and maintenance), with a mechanism of action involving mu-receptor agonism and potential NMDA receptor antagonism. The drug is supplied by Hikma as a bulk pharmaceutical ingredient for clinical and specialty pharmacy use.
LOE Approaching
Product approaching loss of exclusivity with competitive pressure score of 30/100; brand teams should expect declining market share and reduced team investment.
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 principal therapeutic uses for methadone are for analgesia and for detoxification or maintenance…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on methadone involves managing a mature, multi-indication asset in LOE transition; roles focus on regulatory maintenance, generic preparation, and cost management rather than growth. Career advancement may be limited unless transitioning to broader portfolio management or specialty pharmacy operations.
Product Manager (Legacy/Generic Transition)
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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.