DILAUDID (hydromorphone hydrochloride)
Dilaudid is an injectable medication used to manage severe pain in patients who have not found relief with alternative options like non-opioid drugs or combination products. It helps patients whose pain is intense enough to require a potent opioid analgesic and for whom other treatments are either ineffective or poorly tolerated. Because of the risks associated with addiction and misuse, this medication is reserved for situations where severe pain persists and alternative therapies remain inadequate.
How DILAUDID Works
Hydromorphone is a full opioid agonist with relative selectivity for mu-opioid receptors located throughout the brain and spinal cord. Binding to these receptors produces analgesia, though the precise mechanism remains unknown. As a full agonist, hydromorphone exhibits no ceiling effect for analgesia; however, clinical dosage titration is limited by dose-dependent adverse reactions, most notably respiratory and CNS depression.
Details
- Status
- Prescription
- First Approved
- 1984-01-11
- Patent Cliff
- 2034
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION, TABLET
DILAUDID Approval History
What DILAUDID Treats
1 indicationsDILAUDID is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
DILAUDID Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION See full prescribing information for complete boxed warning. • DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) • Serious, life-threatening, or fatal respiratory depression may occur. Mon...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION See full prescribing information for complete boxed warning. • DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of DILAUDID INJECTION are essential. ( 5.2 ) • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ). • If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ). Addiction, Abuse, and Misuse Because the use of DILAUDID INJECTION exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of DILAUDID INJECTION, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of DILAUDID INJECTION are essential [see W
DILAUDID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DILAUDID
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03214510 | 2016-1111 NCI-2018-01124, 2016-1111 | Ph 3 | active not recruiting | Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery |
| NCT01709721 results posted | CNS-HYD201US | Ph 3 | completed | Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration |
| NCT01709747 results posted | CNS-HYD202US | Ph 3 | completed | Single-arm Study to Assess the Safety of Hydromorphone Hydrochloride by Intrathecal Administration |
| NCT02459964 results posted | 2015-0086 NCI-2015-01509 | Ph 4 | completed | Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain |
| NCT04081376 HM | IMIMFTCL/HM | Ph 1 | completed | Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control |
| NCT01986946 results posted | Pro00041252 | Ph 3 | terminated | Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions |
| NCT02110719 Pain | REAG00414HU | Ph 4 | completed | Decreasing Narcotics in Advanced Pelvic Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DILAUDID FDA Label Details
Indications & Usage
FDA Label (PDF)DILAUDID is indicated for the treatment of Pain.
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION See full prescribing information for complete boxed warning. • DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can le...
Pro Intelligence Preview
Deep insights for DILAUDID
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 70 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.