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Details for Generic Name: nicotine

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Nicotine is the generic ingredient in ten branded drugs marketed by Novartis, Sanofi Aventis Us, Aveva, Mcneil Cons, Pharmacia And Upjohn, Pfizer Inc, Glaxosmithkline, Ivax Sub Teva Pharms, Perrigo, Perrigo R And D, Watson Labs, and Glaxosmithkline Cons, and is included in fourty-three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for nicotine. Thirteen suppliers are listed for this compound.

Summary for Generic Name: nicotine

Tradenames:10
Patents:5
Applicants:12
NDAs:43
Drug Master File Entries: see list28
Suppliers: see list13
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents

Pharmacology for Ingredient: nicotine

Ingredient-typeNicotine
Drug ClassCholinergic Nicotinic Agonist

Clinical Trials for: nicotine

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge
Status: Completed Condition: Nicotine Pharmacokinetic Study

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Status: Completed Condition: Smoking Cessation

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Status: Completed Condition: Tobacco Dependence

Nicotine Vaccination and Nicotinic Receptor Occupancy
Status: Completed Condition: Nicotine Dependence

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Status: Completed Condition: Tobacco Dependence

Neural Mechanisms Underlying Nicotine and Alcohol Combinations
Status: Recruiting Condition: Focus: Effects of Nicotine and Alcohol on Brain Circuits

Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
Status: Recruiting Condition: Nicotine Dependence

Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Status: Not yet recruiting Condition: Tobacco Dependence

Nicotine Lozenge Bioequivalence Study
Status: Completed Condition: Smoking Cessation

Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Status: Not yet recruiting Condition: Tobacco Dependence

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Status: Completed Condition: Smoking; Smoking Cessation

Pharmacokinetics of Nicotine Film in Smokers
Status: Not yet recruiting Condition: Smoking Cessation

Effects of IV Nicotine Induced Changes on BOLD fMRI Signal, Hormones, and Subjective Ratings of Stimulant Drug Effect
Status: Recruiting Condition: Nicotine Dependence

Bioequivalence Between an Oral Nicotine Replacement Product and Nicorette® Gum
Status: Completed Condition: Tobacco Dependence

Acute and Chronic Nicotine Modulation of Reinforcement Learning
Status: Recruiting Condition: Nicotine Addiction.

Pharmacogenetics of Nicotine Addiction Treatment
Status: Active, not recruiting Condition: Nicotine Addiction

Nicotine Replacement Therapy in the Intensive Care Unit
Status: Recruiting Condition: Delirium; Psychomotor Agitation; Substance Withdrawal Syndrome; Nicotine Replacement Therapy

Sensitivity to Intravenous Nicotine: Genetic Moderators
Status: Recruiting Condition: Influence of OPRM1 A118G Status on Subjective Responses to IV Nicotine.

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
Status: Completed Condition: Tobacco Dependence

Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes
Status: Completed Condition: Tobacco Abuse Smoke

e-Cigarettes Versus NRT Gum for Smoking Cessation
Status: Terminated Condition: Nicotine Addiction; Smoking Cessation

Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
Status: Completed Condition: Tobacco Dependence

Nicotine Patch, Blood Flow and Oxidative Stress Study
Status: Completed Condition: Healthy

Nicotinic Modulation of the Default Network
Status: Not yet recruiting Condition: Magnetic Resonance Imaging; Cognition; Nicotine; Mecamylamine

Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
Status: Terminated Condition: Tobacco Use Disorder

Nicotine for Marijuana Withdrawal
Status: Recruiting Condition: Marijuana Dependence

Improving the Efficacy of Anti-Nicotine Immunotherapy
Status: Completed Condition: Nicotine Dependence

Nicotine Patch as an Analgesic Adjuvant After Surgery
Status: Completed Condition: Pain

Effects of Electronic Cigarettes on Nicotine Concentrations
Status: Active, not recruiting Condition: Health Behavior

Effects of Nicotine on Brain Opioid Receptors
Status: Terminated Condition: Nicotine Dependence

Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)
Status: Completed Condition: Nicotine Dependence; Smoking Cessation

Concurrent Bupropion / Varenicline for Smoking Cessation
Status: Completed Condition: Nicotine Dependence

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Status: Completed Condition: Nicotine Dependence

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
Status: Completed Condition: Tobacco Dependence

Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)
Status: Completed Condition: Smoking Cessation

Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Status: Completed Condition: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder; Schizophrenia

Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine
Status: Completed Condition: Nicotine Dependence

Manipulating Tobacco Constituents in Female Menthol Smokers
Status: Recruiting Condition: Nicotine Dependence

Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease
Status: Recruiting Condition: Parkinson's Disease

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum
Status: Completed Condition: Tobacco Dependence

4 mg Nicotine Polacrilex Gum and Swedish Portion Snus
Status: Completed Condition: Healthy Subjects; Smokers

Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Status: Completed Condition: Tobacco Dependence

An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Status: Completed Condition: Nicotine Dependence

Randomized Controlled Trial of Mailed Nicotine Replacement Therapy to Canadian Smokers
Status: Active, not recruiting Condition: Smoking

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
Status: Not yet recruiting Condition: Tobacco Use Disorder

Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
Status: Recruiting Condition: Tobacco Use Disorder; Nicotine Dependence

IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior
Status: Suspended Condition: Nicotine Dependence

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
Status: Completed Condition: Smoking

Project 2: Strategies for Reducing Nicotine Content in Cigarettes
Status: Recruiting Condition: Immediate Nicotine Reduction Group; Gradual Nicotine Reduction Group; Normal Nicotine Control Group

Nicotine Treatment of Mild Cognitive Impairment (MCI)
Status: Active, not recruiting Condition: Age-Related Memory Disorders

A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
Status: Completed Condition: Tobacco Dependence

Providing Free Nicotine Patches to Quitline Smokers
Status: Active, not recruiting Condition: Smoking Cessation

Nicotine Replacement for Smoking Cessation During Pregnancy
Status: Recruiting Condition: Nicotine Dependence; Smoking Cessation

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Status: Completed Condition: Smoking; Smoking Cessation

Nicotine Delivery Systems: Research & Treatment
Status: Terminated Condition: Smoking

Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
Status: Suspended Condition: Nicotine Dependence

Study of Nicotine Patch in Pregnancy (SNIPP)
Status: Completed Condition: Smoking

Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Status: Completed Condition: Nicotine Dependence

Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine
Status: Completed Condition: Tobacco Dependence

Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence
Status: Completed Condition: Cannabis Dependence; Nicotine Dependence

Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery
Status: Recruiting Condition: Postoperative; Pain; Nicotine

Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Status: Completed Condition: Tobacco Dependence

Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
Status: Completed Condition: Tobacco Dependence

Effect of Daily Nicotine Patch Application on Mechanical Ventilation Weaning in Smoking Patients
Status: Recruiting Condition: Smoking; Mechanical Ventilation; Intensive Care

Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum
Status: Completed Condition: Tobacco Dependence

Galantamine Effects on Nicotine Responses in Smokers
Status: Completed Condition: Smoking; Tobacco Withdrawal

Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Status: Completed Condition: Nicotine Dependence

Very Low-Nicotine Cigarettes in Smokers With SUD
Status: Not yet recruiting Condition: Nicotine Dependence

Intravenous (IV) Nicotine Self Administration: Dose Ranging and Sex Differences in Smokers
Status: Recruiting Condition: Nicotine Addiction

The Effects of Nicotine on Cognition in Schizophrenia
Status: Completed Condition: Schizophrenia

Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
Status: Active, not recruiting Condition: Smoking Cessation

Oral Tolerability Of Two Nicotine Dosage Forms
Status: Completed Condition: Healthy Volunteer Smokers

Clinical Trial to Evaluate the Efficacy of Smoking Cessation
Status: Completed Condition: Smoking Cessation

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
Status: Completed Condition: Tobacco Dependence

Nicotine Metabolism and Low Nicotine Cigarettes
Status: Not yet recruiting Condition: Smoking

Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Status: Completed Condition: Smoking Cessation

Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3
Status: Completed Condition: Drug Addiction; Smoking Cessation

Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Status: Completed Condition: Tobacco Dependence

Electronic Cigarettes in Daily Dependent Smokers
Status: Recruiting Condition: Substance Withdrawal Syndrome; Nicotine Dependence

A Randomized Trial of Internet Access to Nicotine Patches
Status: Completed Condition: Smoking Cessation; Tobacco Use Disorder

A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum
Status: Completed Condition: Dental Pellicle

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
Status: Completed Condition: Coronary Heart Disease

Innovative Interventions for Smoking Cessation
Status: Completed Condition: Tobacco Use Disorder

Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Status: Completed Condition: Smoking

Extinction Based Treatment for Nicotine Dependence
Status: Active, not recruiting Condition: Nicotine Dependence

Varenicline and Combined Nicotine Replacement Therapy (NRT) for Smoking Cessation
Status: Not yet recruiting Condition: Tobacco Use Cessation

Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Status: Recruiting Condition: Nicotine-free Hookah Smoking

Effect of Nicotine on Chronic Pelvic Pain
Status: Completed Condition: Pelvic Pain

Smoking Reduction or Cessation With Nicotine Replacement Therapy
Status: Completed Condition: Smoking Cessation

Nicotine Treatment of Cognitive Decline in Down Syndrome
Status: Recruiting Condition: Down Syndrome; Mild Cognitive Impairment

Nicotine, Non-Smokers With and Without ADHD, and Genetics Study
Status: Recruiting Condition: Non-smoker; ADHD

Provoked Craving Relief Study by NRT
Status: Completed Condition: Smoking Cessation

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Status: Active, not recruiting Condition: Alcohol Drinking

Smoking Cessation in Women With Gynecological Conditions
Status: Active, not recruiting Condition: Cervical Dysplasia

A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges
Status: Completed Condition: Healthy Volunteer Smokers

Effects of Acute Nicotine Treatment on Neuroplasticity and Memory in Patients With Schizophrenia
Status: Terminated Condition: Schizophrenia

A Pilot Study Evaluating Nicotine Lozenges and Self Help
Status: Completed Condition: Smokeless Tobacco Use

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease
Status: Completed Condition: Idiopathic Parkinson's Disease

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users
Status: Recruiting Condition: Nicotine Dependence

The Effect of Nicotine on Arousal, Cognition and Social Cognition in Young and Elderly Healthy Subjects.
Status: Completed Condition: Schizophrenia; Cognition Disorders

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
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165Aug 2, 1996OTCYes8,663,680<disabled>Y<disabled>
Pfizer Inc
NICOTROL
nicotine
SPRAY, METERED;NASAL020385Mar 22, 1996RXYes5,656,255<disabled><disabled>
Watson Labs
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076569Jul 29, 2004OTCNo<disabled><disabled>
Perrigo R And D
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL091354Jul 20, 2011OTCNo<disabled><disabled>
Watson Labs
NICOTINE POLACRILEX
nicotine polacrilex
GUM, CHEWING;BUCCAL076568Jul 29, 2004OTCNo<disabled><disabled>
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