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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
McKesson
Harvard Business School
Merck
Farmers Insurance
US Department of Justice
Julphar
Cerilliant
Cipla

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021476

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NDA 021476 describes LUNESTA, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from nine suppliers. Additional details are available on the LUNESTA profile page.

The generic ingredient in LUNESTA is eszopiclone. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 021476
Tradename:LUNESTA
Applicant:Sunovion Pharms Inc
Ingredient:eszopiclone
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021476
Suppliers and Packaging for NDA: 021476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUNESTA eszopiclone TABLET;ORAL 021476 NDA Rebel Distributors Corp 21695-225 E 21695-225-30
LUNESTA eszopiclone TABLET;ORAL 021476 NDA Rebel Distributors Corp 21695-226 E 21695-226-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Dec 15, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021476

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Accenture
Harvard Business School
Boehringer Ingelheim
QuintilesIMS
Chubb
Moodys
McKinsey
US Army

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