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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, Paddock Llc, Elite Labs, Lannett, Mallinckrodt, and Nesher Pharms, and is included in twenty-two NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-five patent family members in eighteen countries.

There are thirteen 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:15
NDAs:22
Drug Master File Entries: see list13
Suppliers: see list11
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: hydromorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: hydromorphone hydrochloride

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

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

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

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

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

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

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

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

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

Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Status: Not yet recruiting Condition: Pain

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

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

Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
Status: Recruiting Condition: Chronic 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

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

Hydromorphone Pharmacokinetic-Pharmacodynamic Fingerprint
Status: Withdrawn Condition: Pain; Ventilatory Depression

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

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

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

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Status: Not yet recruiting Condition: Migraine

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

Intrathecal Hydromorphone for Cesarean Section
Status: Recruiting Condition: Pain

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

Hydromorphone and C-section
Status: Completed Condition: Postoperative Pain

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

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

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

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

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

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

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

Multiple Dose Study of Blockade of Opioid Effects of Injections of Buprenorphine in Participants With Opioid Disorder
Status: Completed Condition: Opioid Use Disorder

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Status: Completed Condition: Low Back 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

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

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

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

Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain
Status: Not yet recruiting Condition: Opioid-Related Disorders; Chronic 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

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

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

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

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

Intraoperative Opioids and Postoperative Recovery After Hepatobiliary or Foregut Surgery
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

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

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

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

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

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.

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

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

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

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

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

Satisfactory Analgesia Minimal Emesis in Day Surgeries
Status: Recruiting Condition: Pain; Post Operative Nausea and Vomiting

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

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

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

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

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

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

Post-tonsillectomy Pain Control in Adults
Status: Not yet recruiting Condition: Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Hemorrhage; Body Weight Changes

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

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee
Status: Recruiting Condition: Unilateral Knee Arthroplasty

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

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

Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery
Status: Not yet recruiting Condition: Conditions Requiring Colorectal Surgery

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: Withdrawn 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

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

Epidural Anesthesia Within an Enhanced Recovery Pathway in Reducing Pain in Patients Undergoing Gynecologic Surgery
Status: Recruiting Condition: Intraoperative Complication; Malignant Female Reproductive System Neoplasm; Pain

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-002Sep 24, 2004DISCNNo6,589,960<disabled>Y<disabled>
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-003Sep 24, 2004DISCNNo6,589,960<disabled>Y<disabled>
Actavis Labs Fl Inc
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL202144-001May 12, 2014RXNo<disabled><disabled>
Hospira Inc
HYDROMORPHONE HYDROCHLORIDE
hydromorphone hydrochloride
INJECTABLE;INJECTION200403-003Dec 1, 2011RXNo<disabled><disabled>
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 2004DISCNNo6,743,442<disabled>Y<disabled>
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International Patent Family for Ingredient: hydromorphone hydrochloride

Country Document Number Publication Date
European Patent Office1449531Sep 22, 2004
Spain2338641May 11, 2010
Germany69529412Jul 31, 2003
European Patent Office1449530Sep 22, 2004
South Africa9509367Jun 13, 1996
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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