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Last Updated: July 21, 2024

LUNESTA Drug Patent Profile


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When do Lunesta patents expire, and when can generic versions of Lunesta launch?

Lunesta is a drug marketed by Waylis Therap and is included in one NDA.

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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lunesta

A generic version of LUNESTA was approved as eszopiclone by TEVA on May 23rd, 2011.

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Drug patent expirations by year for LUNESTA
Drug Prices for LUNESTA

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Drug Sales Revenue Trends for LUNESTA

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Recent Clinical Trials for LUNESTA

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

SponsorPhase
American Academy of Sleep MedicinePhase 2
Laboratorios Andromaco S.A.Phase 1
University of California, San DiegoPhase 2

See all LUNESTA clinical trials

Paragraph IV (Patent) Challenges for LUNESTA
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 LUNESTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-001 Dec 15, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-002 Dec 15, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Waylis Therap LUNESTA eszopiclone TABLET;ORAL 021476-003 Dec 15, 2004 AB RX Yes Yes ⤷  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 LUNESTA

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

International Patents for LUNESTA

See the table below for patents covering LUNESTA around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 281011 Pravotočivý isomer 6-(5-chlor-2-pyridyl)-5-(4-methyl-1-piperazinyl)karbonyloxy-7-oxo-6,7-dihydro-5H-pyrrolo/3,4-b/pyrazinu, způsob jeho přípravy a farmaceutická kompozice tento isomer obsahující (DEXTROROTATORY ISOMER OF 6-(5-CHLORO-2-PYRIDYL)-5-(4-METHYL-1-PIPERAZINYL)CARBONYLOXY-7-OXO-6,7- -DIHYDRO-5-H-PYRROLO£3,4-b|PYRAZINE, PROCESS OF ITS PREPARATION AND PHARMACEUTICAL COMPOSITION CONTAINING SAID ISOMER) ⤷  Sign Up
South Africa 9200302 ⤷  Sign Up
Tunisia SN92004 DERIVE DE LA 5H-PYRROLO (3,4-B) PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT ⤷  Sign Up
Israel 100677 Dextrorotatory zopiclone its preparation and pharmaceutical compositions containing it ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.