NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1984
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
6/8 — Strong
Priority Review
DILAUDID (hydromorphone hydrochloride) by Fresenius Kabi is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 1984.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DILAUDID (hydromorphone hydrochloride) is a potent mu-opioid receptor agonist indicated for moderate-to-severe pain management, available as an injectable formulation. It works by binding to opioid receptors in the central nervous system to produce analgesia, with no ceiling effect on pain relief. The drug is used across acute, chronic, and perioperative pain settings where parenteral opioid therapy is required.
$0.002BPart D
Peak7.7 years to LOEStable peak-stage product with established market position; brand team focused on market maintenance and compliance rather than aggressive growth initiatives.
Mechanism of Action
mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and…
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.