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Last Updated: July 21, 2024

ESZOPICLONE - Generic Drug Details


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What are the generic sources for eszopiclone and what is the scope of patent protection?

Eszopiclone is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, Teva, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for eszopiclone. Thirty-two suppliers are listed for this compound.

Drug Prices for ESZOPICLONE

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Drug Sales Revenue Trends for ESZOPICLONE

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Recent Clinical Trials for ESZOPICLONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Siriraj HospitalPhase 4
Brigham and Women's HospitalPhase 1/Phase 2
Laboratorios Andromaco S.A.Phase 1

See all ESZOPICLONE clinical trials

Medical Subject Heading (MeSH) Categories for ESZOPICLONE
Anatomical Therapeutic Chemical (ATC) Classes for ESZOPICLONE
Paragraph IV (Patent) Challenges for ESZOPICLONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LUNESTA Tablets eszopiclone 1 mg, 2 mg and 3 mg 021476 10 2008-12-15

US Patents and Regulatory Information for ESZOPICLONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys ESZOPICLONE eszopiclone TABLET;ORAL 091024-002 Apr 15, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd ESZOPICLONE eszopiclone TABLET;ORAL 202929-003 Jan 30, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Pharms Inc ESZOPICLONE eszopiclone TABLET;ORAL 091151-001 Mar 26, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ESZOPICLONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-002 Dec 15, 2004 ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-002 Dec 15, 2004 ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.