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Details for Generic Name: eszopiclone

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Eszopiclone is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Glenmark Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Roxane, Sun Pharma Global, Teva, Wockhardt Ltd, and Sunovion Pharms Inc, and is included in eleven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for eszopiclone. Eleven suppliers are listed for this compound.

Summary for Generic Name: eszopiclone

Tradenames:2
Patents:1
Applicants:11
NDAs:11
Drug Master File Entries: see list20
Suppliers: see list11
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Clinical Trials for: eszopiclone

Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Status: Completed Condition: Post-Traumatic Stress Disorders

The Effects of Eszopiclone and Lexapro on Prefrontal Glutamate and GABA in Depression With Anxiety and Insomnia
Status: Completed Condition: Depression; Anxiety; Insomnia

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Status: Completed Condition: Parkinson's Disease; Insomnia

Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
Status: Completed Condition: Insomnia; Attention Deficit Hyperactivity Disorder

Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Status: Recruiting Condition: Posttraumatic Stress Disorders

Effects of Eszopiclone on Sleep-dependent Learning in Schizophrenia
Status: Completed Condition: Schizophrenia

Effects of Daytime Eszopiclone Administration in Shift Workers
Status: Completed Condition: Shift-Work Sleep Disorder

Eszopiclone in the Treatment of Insomnia and Fibromyalgia
Status: Completed Condition: Fibromyalgia; Insomnia

Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome
Status: Recruiting Condition: Acute Coronary Syndrome; Sleep Disorder

Hypnotics to Improve Polysomnography Yield: Eszopiclone vs Ramelteon?
Status: Completed Condition: Obstructive Sleep Apnea

Effects of Eszopiclone on Sleep and Memory in Schizophrenia
Status: Recruiting Condition: Schizophrenia

Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
Status: Completed Condition: Primary Insomnia

A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Status: Completed Condition: Insomnia

A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
Status: Completed Condition: Primary Insomnia

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
Status: Completed Condition: Insomnia; Generalized Anxiety Disorder

A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
Status: Completed Condition: Major Depressive Disorder; Insomnia

Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
Status: Withdrawn Condition: Healthy

Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
Status: Completed Condition: Insomnia

Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis
Status: Completed Condition: Insomnia; Arthritis, Rheumatoid

Eszopiclone for Improving Sleep in Multiple Sclerosis (MS)
Status: Completed Condition: Relapsing Remitting Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Fatigue

Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Status: Completed Condition: Poor Quality Sleep

Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability
Status: Completed Condition: Primary Insomnia

Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban
Status: Terminated Condition: Insomnia; Nicotine Dependence

6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
Status: Completed Condition: Primary Insomnia

A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Status: Completed Condition: Insomnia

Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder
Status: Completed Condition: Insomnia

Eszopiclone Treatment & Cortisol Responsivity
Status: Completed Condition: Insomnia

Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
Status: Active, not recruiting Condition: Insomnia

Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
Status: Completed Condition: Insomnia; Attention Deficit Hyperactivity Disorder

Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients
Status: Active, not recruiting Condition: Insomnia

Treatment of Insomnia and Glucose Metabolism
Status: Completed Condition: Sleep; Insomnia; Insulin Resistance

A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Status: Not yet recruiting Condition: Insomnia

The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
Status: Completed Condition: Obstructive Sleep Apnea

Study of the Insomnia in Patients With Low Back Pain
Status: Completed Condition: Primary Insomnia

Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Brain Mechanisms and Targeting Insomnia in Major Depression
Status: Active, not recruiting Condition: Major Depressive Disorder; Insomnia

Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
Status: Completed Condition: Obstructive Sleep Apnea Syndrome

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder
Status: Completed Condition: Insomnia; Depressive Disorder, Major

Study of an Evening Dose of Eszopiclone on Next Day Driving Ability & Psychomotor/Memory Function in Healthy Volunteers
Status: Completed Condition: Insomnia

Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Status: Completed Condition: Sleep Initiation and Maintenance Disorders

Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Status: Completed Condition: Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders

Sleep Effectiveness and Insulin and Glucose Homeostasis
Status: Recruiting Condition: Diabetes; Prediabetic; Prediabetes; Glucose Intolerance

Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Status: Completed Condition: Primary Insomnia

The Treatment of Insomnia in Symptomatic Peri- and Postmenopausal Women
Status: Completed Condition: Menopause; Insomnia

Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Status: Completed Condition: Generalized Anxiety Disorder

Insomnia and Osteoarthritis Study
Status: Completed Condition: Osteoarthritis; Insomnia

An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Status: Completed Condition: Healthy Subjects; Sleep Initiation and Maintenance Disorders

Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
Status: Completed Condition: Chronic Insomnia; Primary Insomnia

How do Sleeping Pills Affect Pain in the Brain?
Status: Completed Condition: Primary Insomnia

Auricular Acupuncture for Primary Insomnia
Status: Recruiting Condition: Primary Insomnia

Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)
Status: Completed Condition: Obstructive Sleep Apnea

Treatment of Insomnia in Migraineurs
Status: Completed Condition: Insomnia; Migraine

Safety and Efficacy of Chronic Hypnotic Use 2
Status: Not yet recruiting Condition: Chronic Insomnia

A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
Status: Completed Condition: Insomnia

The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Status: Completed Condition: Marijuana Dependence

Improving Sleep and Psychological Functioning in People With Depression and Insomnia
Status: Active, not recruiting Condition: Sleep Initiation and Maintenance Disorders; Depression

Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Status: Completed Condition: Insomnia

Combination Therapy to Treat Sleep Apnea
Status: Recruiting Condition: Sleep Apnea, Obstructive

Ezopiclone Improves the Quality of Overnight Polysomnography
Status: Completed Condition: Obstructive Sleep Apnea

Testing the Nocturnal Sleep Latency Profile in Primary Insomnia
Status: Completed Condition: Primary Insomnia; Sleep Initiation and Maintenance Disorders

Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
Status: Active, not recruiting Condition: Obstructive Sleep Apnea

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
Roxane
ESZOPICLONE
eszopiclone
TABLET;ORAL091153-001Apr 15, 2014RXNo<disabled><disabled>
Lupin Ltd
ESZOPICLONE
eszopiclone
TABLET;ORAL091124-002Sep 13, 2011RXNo<disabled><disabled>
Glenmark Generics
ESZOPICLONE
eszopiclone
TABLET;ORAL091166-001Apr 15, 2014RXNo<disabled><disabled>
Mylan Pharms Inc
ESZOPICLONE
eszopiclone
TABLET;ORAL091151-003Mar 26, 2013RXNo<disabled><disabled>
Lupin Ltd
ESZOPICLONE
eszopiclone
TABLET;ORAL091124-001Sep 13, 2011RXNo<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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