NDAINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSSOLUTION2 Generics Approved
Approved
Dec 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Hydromorphone hydrochloride is a semi-synthetic opioid analgesic available as an injectable solution (IM, IV, SC routes). It is indicated for moderate to severe pain management in patients requiring opioid therapy. The drug works as a mu-opioid receptor agonist to provide rapid pain relief in acute and chronic pain settings.
Growth16.3 years to LOE
Early-stage growth product with recent approval offers opportunity to build market share; commercial teams will focus on hospital/acute care channels and practitioner adoption.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration
Started Jun 2013
364 enrolled
Chronic Pain
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
Started Feb 2013
153 enrolled
Management of Chronic Pain
An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
Started Dec 2009
260 enrolled
Pain
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
Started Nov 2008
2 enrolled
Cancer Pain
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
Started Oct 2008
141 enrolled
CancerPain
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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.