NDAORALTABLET, EXTENDED RELEASE
Approved
Mar 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
EXALGO (hydromorphone hydrochloride) by Pfizer is hydromorphone, a semi-synthetic morphine derivative, is a hydrogenated ketone of morphine. Approved for chronic pain. First approved in 2010.
Drug data last refreshed 1w ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXALGO is an extended-release oral tablet formulation of hydromorphone hydrochloride, a semi-synthetic mu-opioid receptor agonist derived from morphine. It is indicated for chronic pain management in opioid-tolerant patients. Hydromorphone provides analgesia through mu-opioid receptor agonism in the central nervous system, with potency superior to morphine but clinical dosing limited by respiratory depression and CNS side effects.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30%), signaling potential team restructuring and transition planning for opioid pain management specialists.
Mechanism of Action
Hydromorphone, a semi-synthetic morphine derivative, is a hydrogenated ketone of morphine. Hydromorphone is principally an agonist of mu-receptors, showing a weak affinity for k-receptors. Comparing relative binding affinity for mu- and k-opioid receptors, hydromorphone binds more specifically to…
Indications (1)
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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.