NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1984
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
Priority Review
DILAUDID (hydromorphone hydrochloride) by Fresenius Kabi is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Approved for chronic pain. First approved in 1984.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DILAUDID (hydromorphone hydrochloride) is a potent mu-opioid receptor full agonist approved since 1984 for chronic pain and respiratory insufficiency management. It works by binding to opioid receptors in the central nervous system to produce analgesia with no ceiling effect. The drug is administered via injection and is currently in peak lifecycle stage.
$0.002BPart D
Peak7.9 years to LOEPeak-stage product with minimal Part D spending ($2K annually) suggests niche market positioning; limited commercial team expansion expected.
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 (1)
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.