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Dilaudid
Dilaudid, marketed by the University of Illinois College of Medicine at Peoria, is an established opioid analgesic with a key composition patent expiring in 2028. The drug's primary strength lies in its well-documented efficacy for pain management, supported by its long-standing market presence. The primary risk is the potential increase in generic competition following the 2028 patent expiry, which could erode market share and revenue.
At a glance
| Generic name | Dilaudid |
|---|---|
| Sponsor | University of Illinois College of Medicine at Peoria |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 o
Common side effects
- Lightheadedness
- Dizziness
- Sedation
- Nausea
- Vomiting
- Sweating
- Flushing
- Dysphoria
- Euphoria
- Dry mouth
- Pruritus
- Constipation
Serious adverse events
- Respiratory depression
- Apnea
- Respiratory arrest
- Cardiac arrest
- Circulatory depression
- Shock
- Serotonin syndrome
- Anaphylaxis
- Adrenal insufficiency
- Opioid-induced esophageal dysfunction
Key clinical trials
- Hydromorphone With Electroacupuncture and Ear Acupoint Pressing for Refractory Cancer Pain (EARLY_PHASE1)
- Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (NA)
- Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (PHASE4)
- Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (PHASE3)
- Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial (PHASE4)
- Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery (PHASE4)
- Assessing Hydromorphone Sustained-Release Tablets in Elderly Cancer Pain Patients With Renal Insufficiency
- Buprenorphine for Analgesia in Older Adults With Acute Fractures in the Emergency Department: a Randomized Controlled Study (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dilaudid CI brief — competitive landscape report
- Dilaudid updates RSS · CI watch RSS
- University of Illinois College of Medicine at Peoria portfolio CI