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Profile for Tradename: LUNESTA

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Lunesta is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in LUNESTA is eszopiclone. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.

Summary for Tradename: LUNESTA

Suppliers / Packagers: see list48
2013 Sales:$851,791,000

Clinical Trials for: LUNESTA

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

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

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

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

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

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

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

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

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

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

Courtesy of
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
Sunovion Pharms Inc
TABLET;ORAL021476-001Dec 15, 2004RXNo6,444,673*PED<disabled> <disabled>
Sunovion Pharms Inc
TABLET;ORAL021476-003Dec 15, 2004RXYes6,444,673*PED<disabled> <disabled>
Sunovion Pharms Inc
TABLET;ORAL021476-002Dec 15, 2004RXNo6,444,673*PED<disabled> <disabled>
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Paragraph IV activity for: LUNESTA

Drugname Dosage Strength RLD Submissiondate
eszopicloneTablets1 mg, 2 mg and 3 mgLunesta12/15/2008
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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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