NDAORALSYRUP
Approved
Aug 1947
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DOLOPHINE 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. Approved for hiv infection, candidiasis. First approved in 1947.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dolophine (methadone hydrochloride) is a synthetic opioid mu-agonist approved in 1947 for analgesia and opioid addiction treatment via oral syrup formulation. It acts on the central nervous system and smooth muscle organs, with a slower onset and more prolonged but less severe withdrawal syndrome compared to morphine; some evidence suggests NMDA receptor antagonism may contribute to its efficacy.
LOE Approaching
Product nearing loss of exclusivity with low competitive pressure (30%), suggesting smaller brand teams focused on generic transition planning and regulatory maintenance.
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…
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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.