You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021476


✉ Email this page to a colleague

« Back to Dashboard


NDA 021476 describes LUNESTA, which is a drug marketed by Woodward and is included in one NDA. It is available from two 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-two suppliers are listed for this compound. Additional details are available on the eszopiclone profile page.
Summary for 021476
Tradename:LUNESTA
Applicant:Woodward
Ingredient:eszopiclone
Patents:0
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 Sumitomo Pharma America, Inc. 63402-190 63402-190-30 30 TABLET, COATED in 1 BOTTLE (63402-190-30)
LUNESTA eszopiclone TABLET;ORAL 021476 NDA Sumitomo Pharma America, Inc. 63402-191 63402-191-03 30 TABLET, COATED in 1 BOTTLE (63402-191-03)

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
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
Woodward LUNESTA eszopiclone TABLET;ORAL 021476-002 Dec 15, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.