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Details for Generic Name: hydromorphone hydrochloride

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Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Purdue Pharm Prods, Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Roxane, Mallinckrodt Inc, Actavis Labs Fl Inc, Elite Labs, Lannett, Mallinckrodt, and Nesher Pharms, and is included in twenty-one NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for hydromorphone hydrochloride. Eleven suppliers are listed for this compound.

Summary for Generic Name: hydromorphone hydrochloride

Tradenames:5
Patents:8
Applicants:14
NDAs:21
Drug Master File Entries: see list11
Suppliers: see list11
Therapeutic Class:Analgesics

Pharmacology for Ingredient: hydromorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: hydromorphone hydrochloride

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Status: Completed Condition: Postoperative Pain

Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration
Status: Recruiting Condition: Chronic Pain

Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
Status: Recruiting Condition: Management of Chronic Pain

Methadone and Hydromorphone For Spinal Surgery
Status: Recruiting Condition: Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain

Association Between Body Size and Response to Hydromorphone in ED
Status: Recruiting Condition: Pain

Fixed Dose of Intravenous Hydromorphone in the Treatment of Acute Pain
Status: Completed Condition: Acute Pain

Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
Status: Terminated Condition: Pain; Respiratory Depression

Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
Status: Not yet recruiting Condition: Healthy; Human; Adult; Parturient

Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene
Status: Completed Condition: Healthy Volunteers

Intrathecal Hydromorphone for Pain Control After Cesarean Section
Status: Recruiting Condition: Pain; Cesarean Section

Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain
Status: Recruiting Condition: Pain

Titration of Intravenous Hydromorphone
Status: Recruiting Condition: Acute Severe Pain

Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients
Status: Completed Condition: Cancer Pain

A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Status: Completed Condition: Pain

Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)
Status: Completed Condition: Post Operative Pain

Use of Intrathecal Hydromorphone in Elective Cesarean Deliveries
Status: Active, not recruiting Condition: Pain

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
Status: Completed Condition: Pain

Effect of Dose on the Pharmacokinetics of OROS Hydromorphone Under Fasted Conditions in Healthy Taiwanese Participants
Status: Completed Condition: Healthy Volunteers

Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
Status: Completed Condition: Neuropathic 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
Status: Completed Condition: Cancer; Pain

Comparing Intravenous Hydromorphone to Usual Care
Status: Active, not recruiting Condition: Pain

Intrathecal Hydromorphone for Labor Analgesia
Status: Not yet recruiting Condition: Pregnancy

Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery
Status: Recruiting Condition: Nausea

Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint
Status: Enrolling by invitation Condition: Pain; Ventilatory Depression

Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
Status: Completed Condition: Pain

An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain
Status: Completed Condition: Cancer Pain

Ketamine and Hydromorphone for Patient Controlled Pain Relief in Children's Mucositis
Status: Withdrawn Condition: Mucositis

Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets
Status: Completed Condition: Healthy

Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Status: Terminated Condition: Pain

Intrathecal Hydromorphone for Cesarean Section
Status: Recruiting Condition: Pain

Pain Therapy After Elective Cardiac Surgery
Status: Completed Condition: Pain

Intrathecal Hydromorphone for Labor Analgesia
Status: Completed Condition: Labor Pain

A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer
Status: Completed Condition: Pain

Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)
Status: Active, not recruiting Condition: Opioid Dependence; Heroin Dependence

Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain
Status: Completed Condition: Chronic Low Back Pain

Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients
Status: Active, not recruiting Condition: Pain

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Status: Active, not recruiting Condition: Low Back Pain

Multiple Dose Study of Blockade of Opioid Effects of Injections of Buprenorphine in Participants With Opioid Disorder
Status: Active, not recruiting Condition: Opioid Use Disorder

Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Status: Recruiting Condition: Analgesia, Obstetrical; Cesarean Section

Fentanyl for Breakthrough Pain in the Emergency Department
Status: Terminated Condition: Pain

Safety and Tolerability of Long-Term Administration of Hydromorphone HCI CR (Controlled Release)
Status: Completed Condition: Pain; Analgesics, Opioid

Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain
Status: Completed Condition: Analgesics, Opioid; Pain

Postoperative Pain Therapy With Hydromorphone Using TCI-PCA
Status: Recruiting Condition: Postoperative Pain

Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain
Status: Completed Condition: Pain

An Observational Study to Investigate Clinical Usefulness of OROS Hydromorphone in Korean Cancer Patients
Status: Completed Condition: Pain

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Status: Completed Condition: Constipation

The Effects of Hydromorphone on Responses to Verbal Tasks
Status: Not yet recruiting Condition: Healthy

Safety and Efficacy Study of Hydromorphone and Morphine
Status: Active, not recruiting Condition: Pain

Safety of Hydromorphone in Adult Patients Presenting to the Emergency Department With Acute Severe Pain
Status: Completed Condition: Acute Pain

The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade
Status: Active, not recruiting Condition: Postoperative Pain

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.
Status: Completed Condition: Pain; Analgesics, Opioid

A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
Status: Completed Condition: Analgesics, Opioid; Pain

A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
Status: Completed Condition: Pain; Analgesics; Opioid

Hydromorphone and C-section
Status: Enrolling by invitation Condition: Postoperative Pain

A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain
Status: Completed Condition: Pain; Analgesics, Opioid.

The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia
Status: Completed Condition: Pain Measurement; Visual Analog Pain Scale

Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
Status: Terminated Condition: Chronic Non-Malignant Pain

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
Status: Completed Condition: Pain; Osteoarthritis, Hip; Osteoarthritis, Knee

Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain
Status: Recruiting Condition: Acute Pain

Protocolized vs Discretionary Use of Opioids in Acute Pain
Status: Completed Condition: Pain

Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
Status: Completed Condition: Low Back Pain

A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain
Status: Completed Condition: Pain, Postoperative; Orthopedic Procedures; Analgesia

Protocolized vs Nonprotocolized Treatment of Adult ED Patients With Acute Severe Pain
Status: Completed Condition: Acute Pain

Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
Status: Completed Condition: Pain; Prostate Cancer

Ketamine Patient-Controlled Analgesia for Acute Pain
Status: Enrolling by invitation Condition: Acute Pain; Multiple Trauma; Fractures

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
Status: Terminated Condition: Cancer Pain

Comparing Acute Pain Management Protocols for Patients With Sickle Cell Disease
Status: Not yet recruiting Condition: Sickle Cell Disease

Topical Hydromorphone for Wound Healing
Status: Terminated Condition: Wound Healing

Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone
Status: Recruiting Condition: Acute Pain

Satisfactory Analgesia Minimal Emesis in Day Surgeries
Status: Not yet recruiting Condition: Pain; Post Operative Nausea and Vomiting

Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Status: Completed Condition: Chronic Pain

An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg
Status: Completed Condition: Analgesia

A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic OA Pain
Status: Completed Condition: Chronic Pain

Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance
Status: Recruiting Condition: Opioid Dependence; Pain; Addiction

An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)
Status: Completed Condition: Osteoarthritis, Knee; Osteoarthritis, Hip

A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis
Status: Completed Condition: Osteoarthritis, Hip; Osteoarthritis, Knee

An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg
Status: Completed Condition: Analgesia

A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back Pain
Status: Completed Condition: Low Back Pain

Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Status: Completed Condition: Post Operative Pain

The Pain Pen for Breakthrough Cancer Pain
Status: Terminated Condition: Neoplasms; Pain

Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
Status: Completed Condition: Heroin Dependence; Opioid-Related Disorders

Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
Status: Completed Condition: Heroin Dependence; Opioid-Related Disorders

ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Status: Completed Condition: Opiate Dependence

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Status: Recruiting Condition: Lumbar Spine Fusion; Pain; Back Pain

Methadone Versus Placebo in Spine Fusion
Status: Withdrawn Condition: Postoperative Pain

A Comparison Trial Between PCA and Epidural Analgesia for Pectus Excuvatum Repair
Status: Recruiting Condition: Pectus Excavatum

Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
Status: Completed Condition: Postoperative Pain

Abciximab (ReoPro) as a Therapeutic Intervention for Sickle Cell Vaso-Occlusive Pain Crisis
Status: Recruiting Condition: Sickle Cell Disease; Hb-SS Disease With Vasoocclusive Pain; Hemoglobin SS Disease With Vasoocclusive Crisis; Other Sickle Cell Disease With Vaso-Occlusive Pain; Hemoglobin SS Disease With Crisis

The Discriminative Effects of Tramadol in Humans
Status: Completed Condition: Opioid Abuse; Opioid Addiction; Stimulant Abuse; Stimulant Addiction

Intravenous Remifentanil for Labor Analgesia
Status: Completed Condition: Labor Pain

Bunionectomy Study (0000-063)
Status: Completed Condition: Acute Pain

Study of Opioid Rotation Versus Opioid Escalation in Patients With Moderate to Severe Cancer Pain
Status: Not yet recruiting Condition: Cancer; Pain

Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals
Status: Recruiting Condition: Analgesic Response

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Status: Recruiting Condition: Tumor; Cancer Pain; Breakthrough Cancer Pain; Neuropathic Pain

Palliation of Dyspnea in Advanced Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease (COPD)

Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Status: Completed Condition: Low Back Pain

Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy
Status: Completed Condition: Postoperative Ileus

Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy
Status: Recruiting Condition: Laparoscopic Colorectal Resection

Epidural Analgesia or Patient-Controlled Analgesia in Treating Patients Who Have Undergone Surgery for Gynecologic Cancer
Status: Completed Condition: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Pain; Perioperative/Postoperative Complications; Sarcoma

Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy
Status: Active, not recruiting Condition: Pain; Vertigo; Nausea; Pruritus

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharm Prods
DILAUDID-HP
hydromorphone hydrochloride
INJECTABLE;INJECTION019034Aug 4, 1994RXYes6,589,960<disabled>Y<disabled>
Nesher Pharms
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL077311Nov 9, 2005DISCNNo<disabled><disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217Mar 1, 2010RXNo5,702,725<disabled>Y<disabled>
Roxane
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET;ORAL074597Jul 29, 1998RXNo<disabled><disabled>
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217Aug 24, 2012RXYes5,702,725<disabled>Y<disabled>
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