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Details for Generic Name: tramadol hydrochloride

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Tramadol hydrochloride is the generic ingredient in six branded drugs marketed by Cipher Pharms Inc, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Lupin Ltd, Par Pharm Inc, Sun Pharma Global, Valeant Intl, Shionogi Inc, Accord Hlthcare Inc, Allied Pharma Inc, Amneal Pharms, Apotex, Asta, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mallinckrodt, Mutual Pharm, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Sandoz, Sun Pharm Inds Inc, Teva, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-two NDAs. There are five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-five drug master file entries for tramadol hydrochloride. Twenty suppliers are listed for this compound.

Summary for Generic Name: tramadol hydrochloride

Tradenames:6
Patents:5
Applicants:30
NDAs:32
Drug Master File Entries: see list35
Suppliers: see list20
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tramadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: tramadol hydrochloride

Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
Status: Active, not recruiting Condition: Laparoscopic Nissen Fundoplication

A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain
Status: Completed Condition: Pain, Postoperative

Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
Status: Completed Condition: Low Back Pain

An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
Status: Completed Condition: Low Back Pain

Oral Treatment for Post-operative Gynaecological Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Status: Completed Condition: Acute Pain

Oral Treatment for Post-operative Orthopaedic Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Status: Completed Condition: Acute Pain

Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
Status: Completed Condition: Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery

A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers
Status: Completed Condition: Healthy

Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants
Status: Recruiting Condition: Healthy

An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Status: Completed Condition: Low Back Pain; Shoulder Pain; Neck Pain

An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Status: Completed Condition: Pain; Fibromyalgia

A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
Status: Completed Condition: Diabetic Neuropathy

A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis
Status: Completed Condition: Osteoarthritis

A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
Status: Completed Condition: Healthy Subjects; Pharmacokinetics; Bioavailability

An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients
Status: Completed Condition: Pain

A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
Status: Completed Condition: Chronic Pain

A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions
Status: Completed Condition: Healthy

A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis, Knee; Pain

Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Status: Completed Condition: Pain

An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Status: Completed Condition: Osteoarthritis; Low Back Pain

An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Status: Completed Condition: Pain

A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain
Status: Completed Condition: Chronic Pain

A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery
Status: Completed Condition: Surgery, Oral; Pain, Postoperative

ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.
Status: Completed Condition: Arthritis, Rheumatoid

Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
Status: Completed Condition: Back Pain

A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
Status: Completed Condition: Pain; Postoperative Pain

A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis
Status: Completed Condition: Osteoarthritis

A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain
Status: Terminated Condition: Back Pain; Low Back Pain

A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers
Status: Completed Condition: Healthy

A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
Status: Completed Condition: Chronic Pain

A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)
Status: Completed Condition: Chronic Pain

A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
Status: Completed Condition: Healthy

Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation
Status: Terminated Condition: Premature Ejaculation

A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
Status: Completed Condition: Migraine; Head Pain; Headache

Study to Evaluate Efficacy and Safety in Males Subjects With Premature Ejaculation
Status: Terminated Condition: Premature Ejaculation

Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
Status: Completed Condition: Healthy

Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
Status: Completed Condition: Renal Calculus

A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
Status: Completed Condition: Healthy

A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
Status: Completed Condition: Sprains and Strains; Pain

A Study Comparing the Effectiveness and Safety of Extended Release Tramadol Versus Placebo for the Treatment of Osteoarthritis (OA) of the Knee
Status: Completed Condition: Chronic Pain

A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
Status: Completed Condition: Diabetic Neuropathies

An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis, Knee

A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Status: Completed Condition: Low Back Pain

A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.
Status: Completed Condition: Chronic Pain

Comparison of Pain Therapeutic Effects After Benign Mastectomy
Status: Completed Condition: Pain, Postoperative; Mastectomy

Comparison of Butorphanol and Tramadol Associated Patient-Controlled Analgesia (PCA) After Hysterectomy
Status: Completed Condition: Postoperative Pain; Hysterectomy

Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children
Status: Recruiting Condition: Postoperative Nausea and Vomiting

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Status: Completed Condition: Tonsillitis; Pain

Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
Status: Not yet recruiting Condition: Sciatica; Intervertebral Disc Displacement

A Study of ULTRAM ER at Two Dose Levels in Adolescents With Pain
Status: Completed Condition: Pain

A Pharmacokinetic, Tolerability, and Safety Study of ULTRAM ER in Children With Pain
Status: Completed Condition: Pain

A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain
Status: Completed Condition: Chronic Pain

A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
Status: Completed Condition: Pain; Osteoarthritis

Efficacy and Safety of Postoperative Intravenous Parecoxib Sodium Followed by Oral Celecoxib in Osteoarthritis Patients
Status: Recruiting Condition: Pain; Inflammation

Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Status: Active, not recruiting Condition: Post-Traumatic Stress Disorder

Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Status: Completed Condition: Pain

Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.
Status: Completed Condition: To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients

To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
Status: Recruiting Condition: Pain Management; Cesarean Section

Penthrox Versus Tramadol for SCDF
Status: Recruiting Condition: Acute Pain

Cyclobenzaprine Extended Release (ER) for Fibromyalgia
Status: Recruiting Condition: Fibromyalgia; Pain; Sleep; Fatigue

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
Teva
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075977-001Jun 19, 2002RXNo<disabled><disabled>
Mallinckrodt
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL075983-001Jun 25, 2002RXNo<disabled><disabled>
Par Pharm Inc
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL078783-002Nov 13, 2009RXNo<disabled><disabled>
Northstar Hlthcare
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET;ORAL078935-001May 26, 2010RXNo<disabled><disabled>
Anchen Pharms
TRAMADOL HYDROCHLORIDE
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200491-001Jun 27, 2012RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

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

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