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Details for Generic Name: lidocaine hydrochloride

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Lidocaine hydrochloride is the generic ingredient in thirty-five branded drugs marketed by Akorn, Carlisle, Abbott, Abraxis Pharm, Bel Mar, Dell Labs, Elkins Sinn, Eurohlth Intl Sarl, Gd Searle Llc, Graham Chem, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Watson Labs, Wyeth Ayerst, Baxter Hlthcare, B Braun, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Pharmaton, Meridian Medcl Techn, Astrazeneca, Dentsply Pharm, Banner Life Sciences, Sagent Pharms, G And W Labs Inc, Watson Labs Inc, Oak Pharms, Hi Tech Pharma, Wockhardt, Actavis Mid Atlantic, Vintage, Roxane, Kendall Il, Igi Labs Inc, Paco, Powder Pharms, and Pfizer, and is included in ninety-eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-two patent family members in thirty-four countries.

There are twenty-nine drug master file entries for lidocaine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for Generic Name: lidocaine hydrochloride

Drug Master File Entries: see list29
Suppliers / Packaging: see list90
Therapeutic Class:Anesthetics

Clinical Trials for: lidocaine hydrochloride

Tumescent Lidocaine Maximum Safe mg/kg Dosage
Status: Enrolling by invitation Condition: Anesthesia

Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization
Status: Recruiting Condition: Uterine Leiomyomas

Lidocaine Infusion as a Treatment for Cocaine Relapse and Craving
Status: Recruiting Condition: Cocaine Addiction

Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy
Status: Completed Condition: Postoperative Pain

Lidocaine: Effect of Lidocaine in Chronic Cough
Status: Completed Condition: Chronic Cough

Lidocaine Infusion for Chronic Pain in Opioid Dependent Patients
Status: Recruiting Condition: Chronic Pain

Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Status: Completed Condition: Unstable Angina; Coronary Artery Bypass Graft; Dexmedetomidine; Lidocaine; Myocardial Injury; Arrhythmia; Blood Electrolyte Balance

Clinical Outcomes of Buffered vs. Non-Buffered Lidocaine
Status: Recruiting Condition: Blood Levels of Buffered vs Non-buffered Lidocaine; Anesthetics, Local

A Dose-response Study of Lidocaine and Etomidate
Status: Completed Condition: Etomidate Overdose of Undetermined Intent

Subcutaneous Lidocaine For Cancer-Related Pain
Status: Recruiting Condition: Cancer-related Pain

Effect of Intravenous Lidocaine and Dexamethasone Combination on Postoperative Sore Throat, Cough and Hoarseness.
Status: Completed Condition: Postoperative Sore Throat, Cough, Hoarseness

The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy
Status: Recruiting Condition: Postoperative Pain

Epidural Anesthesia With Chloroprocaine Versus Lidocaine
Status: Completed Condition: Anesthesia

Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine
Status: Completed Condition: Pain, Postoperative

Intravenous Lidocaine for Fibromyalgia
Status: Completed Condition: Fibromyalgia

A Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
Status: Not yet recruiting Condition: Pain

Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy
Status: Recruiting Condition: Endometrial Biopsy; Abnormal Uterine Bleeding

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy
Status: Recruiting Condition: Gall Stone Disease

Self-administered Intravaginal 2% Lidocaine Gel Prior to Intrauterine Device Insertion in Nulliparous Women
Status: Active, not recruiting Condition: Pain

Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
Status: Withdrawn Condition: Pain

Lidocaine 5% Plasters (Versatis® 5%) in Pediatric Neuropathic Pains and Vasoocclusive Sickle Cell Crisis Pains
Status: Completed Condition: Neuropathic Pains; Vasoocclusive Sickle Cell Crises Pains

Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery
Status: Not yet recruiting Condition: Pregnancy

A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
Status: Completed Condition: Postherpetic Neuralgia; Diabetic Neuropathy; Complex Regional Pain Syndrome; Carpal Tunnel Syndrome; HIV Neuropathy; Idiopathic Sensory Neuropathy; Peripheral Neuropathy

Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
Status: Completed Condition: Other Preterm Infants

Lidocaine and Ketamine in Abdominal Surgery
Status: Terminated Condition: Hysterectomy

PK Intravenous Lidocaine Infusion
Status: Enrolling by invitation Condition: Colorectal Surgery

To Evaluate Reduction of Pain in Wounds Treatment Previously Applying Lidocaine Topical Solution vs Placebo
Status: Recruiting Condition: Wounds; Local Anesthesia

Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
Status: Completed Condition: Chronic Low Back Pain

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
Status: Completed Condition: Pain During Hysteroscopy

Endovenous Lidocaine and Serum Cytokines Concentration
Status: Completed Condition: Cholelithiasis

Lubricant Versus Lidocaine Gel for Pain Control During Urodynamics
Status: Completed Condition: Pelvic Floor Disorders

Efficacy of Variable Lidocaine Concentrations in Tumescent Anesthesia for Pain Control During and After Endovenous Laser Procedure; Non-inferiority Trial
Status: Not yet recruiting Condition: Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration

Perioperative Systemic Lidocaine for Enhanced Bowel Recovery After Bariatric Surgery
Status: Recruiting Condition: Obesity; Bariatric Surgery Candidate

Comparison of the Total Dose and Efficacy of Two Lidocaine Concentrations Needed for Cutaneous Surgery Local Anesthesia
Status: Completed Condition: Anesthesia

Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Status: Terminated Condition: Neuropathic Pain; Chronic Pain; Multiple Sclerosis

Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy
Status: Completed Condition: Pain, Postoperative; Analgesic Requirement; Stress Response; Return of Bowel Activity; Inadequate or Impaired Respiratory Function

Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Status: Active, not recruiting Condition: Provoked, Localized Vulvodynia; Provoked Vestibulodynia; Vulvar Vestibulitis; Vulvodynia

Lidocaine-Prilocaine Cream (EMLA) Topical Application Versus Wound Infiltration With Lidocaine After Cesarean Section
Status: Recruiting Condition: Post Operative Pain

Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia
Status: Recruiting Condition: Vulvodynia; Dyspareunia; Vestibulodynia

Tenaculum Pain Control Study
Status: Completed Condition: Cervical Pain; Pelvic Pain

Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
Status: Completed Condition: Pain

Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
Status: Recruiting Condition: Thyroidectomy; Nerve Monitoring

2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula
Status: Recruiting Condition: Infraclavicular Brachial Plexus Block

Safety and Efficacy Study of Lidocaine Mixed Hyaluronate on Nasolabial Folds Correction
Status: Not yet recruiting Condition: Nasolabial Folds Correction; Pain

Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Status: Recruiting Condition: Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain

Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?
Status: Recruiting Condition: Pain

The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm
Status: Terminated Condition: Laryngospasm

Lidocaine on Pain Relief and IL and Substance P in Fibromyalgia
Status: Recruiting Condition: Fibromyalgia

Lidocaine and Neuroma Pain Related Modalities
Status: Completed Condition: Neuropathic Pain

Comparison of Different Propofol Formulations
Status: Completed Condition: General Anesthesia

The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement
Status: Completed Condition: Pain

Use of Lidocaine in Rapid Sequence Induction
Status: Completed Condition: Hemodynamic Response

Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain
Status: Terminated Condition: Chronic Low Back Pain

A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization
Status: Completed Condition: Urinary Tract Infection

Influence of Dexmedetomidine and Lidocaine on Opioid Consumption in Laparoscopic Intestine Resection
Status: Active, not recruiting Condition: Opioid-Related Disorders; Neuralgia

Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation
Status: Terminated Condition: Pain

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Status: Completed Condition: Fascicular Block; Motor Activity; Pain, Postoperative; Latency Period

Effect of Lidocaine and Esmolol to Improve the Quality of Recovery
Status: Terminated Condition: Pain; Constipation; Nausea; Vomiting

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery
Status: Completed Condition: Anesthesia

J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
Status: Terminated Condition: Pain

Lidocaine Lubricant in Pediatric Urethral Catheterization
Status: Completed Condition: Fevers; Pain

Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation
Status: Completed Condition: Other Intraoperative Cardiac Functional Disturbances During Cardiac Surgery

The Effect of Intravenous Lidocaine on Allodynia
Status: Active, not recruiting Condition: Pain

Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).
Status: Recruiting Condition: Pain

Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits
Status: Completed Condition: Irreversible Pulpitis; Pain

The Effect of Intravenous Lidocaine on Pain After Tonsillectomy
Status: Not yet recruiting Condition: Postoperative Pain

The Effect of Intravenous Lidocaine on Pain After Thyroidectomy
Status: Recruiting Condition: Postoperative Pain

The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
Status: Completed Condition: Postoperative Pain

Efficacy Study of Articaine Versus Lidocaine as Supplemental Infiltration in Inflamed Molars
Status: Completed Condition: Irreversible Pulpitis

Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery
Status: Recruiting Condition: Pregnancy; Surgery; Pain

Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery
Status: Not yet recruiting Condition: Obesity; Bariatric Surgery

Lidocaine Analgesia For Removal Of Wound Vac Dressings
Status: Completed Condition: Pain

Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration
Status: Completed Condition: Pain

Lidocaine on Manifestations of Fibromyalgia
Status: Completed Condition: Fibromyalgia; Chronic Pain

Effect of Perioperative Intravenous Lidocaine on Opioid Consumption and Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernioplasty
Status: Recruiting Condition: Pain, Postoperative

Treatment of Myofascial Pain Syndrome With Lidocaine Injection and Physical Therapy.
Status: Completed Condition: Myofascial Pain Syndrome; Pain; Myofascial Trigger Point Pain; Musculoskeletal Pain

Effect of Tumescent Lidocaine on Platelet Function
Status: Completed Condition: Postoperative Thromboembolism

Brain Imaging of Lidoderm for Chronic Back Pain
Status: Completed Condition: Low Back Pain

Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
Status: Completed Condition: Pain

Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain
Status: Recruiting Condition: Postherpetic Neuralgia; Diabetic Polyneuropathy; Peripheral Neuropathy

Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine
Status: Completed Condition: Drug Usage

Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
Status: Completed Condition: Postoperative Pain

Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee
Status: Completed Condition: Osteoarthritis, Knee

Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients
Status: Not yet recruiting Condition: Pain

A Study to Assess Analgesic Efficacy of Intravenous Lignocaine
Status: Completed Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Postoperative Ileus

A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain
Status: Completed Condition: Chronic Low Back Pain

Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)
Status: Completed Condition: Dysmenorrhea

A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride
Status: Completed Condition: Facial Tissue Augmentation

Effect of Sodium Bicarbonate Buffered Lidocaine on the Success of IAN Block of Teeth With Irreversible Pulpitis
Status: Completed Condition: Local Anesthesia

Intraureteral Lidocaine for Post-Ureteroscopy Pain
Status: Recruiting Condition: Ureteral Calculi; Renal Calculi

Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis of the Knee

Topical Pancreatic Duct Lidocaine for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Status: Completed Condition: Pancreatitis

Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
Status: Terminated Condition: Pain

Routine Irrigation With Ropivacaine vs. Lidocaine vs. Saline of Surgical Bed in Sleeve Gastrectomy
Status: Not yet recruiting Condition: Overweight and Obesity

Bupivacaine Versus Lidocaine on Inflammatory Regulation Following Endodontic Surgery
Status: Completed Condition: Pain

Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Status: Completed Condition: Diabetes

Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment
Status: Terminated Condition: Pelvic Pain

Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Status: Completed Condition: Pain

Lidocaine and Pain Management in First Trimester Abortions
Status: Completed Condition: Pain

The Use of Jet Injection Lidocaine for Blood Draws in Young Children
Status: Completed Condition: Pain

Courtesy of
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
lidocaine hydrochloride
INJECTABLE;INJECTION080404-003Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
lidocaine hydrochloride
INJECTABLE;INJECTION085037-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Fresenius Kabi Usa
lidocaine hydrochloride
INJECTABLE;INJECTION016801-001Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: lidocaine hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Powder Pharms
lidocaine hydrochloride
SYSTEM;INTRADERMAL022114-001Aug 16, 20075,630,796<disabled>
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International Patent Family for Ingredient: lidocaine hydrochloride

Country Document Number Publication Date
Slovakia124895Jan 08, 1997
Hong Kong1000351Mar 06, 1998
Latvia11833Aug 20, 1997
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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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