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 Woodward 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.
Summary for LUNESTA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 45 |
Patent Applications: | 3,637 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LUNESTA |
What excipients (inactive ingredients) are in LUNESTA? | LUNESTA excipients list |
DailyMed Link: | LUNESTA at DailyMed |
Recent Clinical Trials for LUNESTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Laboratorios Andromaco S.A. | Phase 1 |
University of California, San Diego | Phase 2 |
VA Office of Research and Development | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for LUNESTA
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Woodward | LUNESTA | eszopiclone | TABLET;ORAL | 021476-001 | Dec 15, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Woodward | LUNESTA | eszopiclone | TABLET;ORAL | 021476-002 | Dec 15, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Woodward | LUNESTA | eszopiclone | TABLET;ORAL | 021476-003 | Dec 15, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 |
---|---|---|---|---|---|---|---|
Woodward | LUNESTA | eszopiclone | TABLET;ORAL | 021476-001 | 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 | 021476-002 | 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 | 021476-003 | 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 |
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) | ⤷ Try a Trial |
Poland | 166976 | ⤷ Try a Trial | |
Slovakia | 279060 | ⤷ Try a Trial | |
South Africa | 9200302 | ⤷ Try a Trial | |
Ireland | 66110 | Optically active 5H-pyrrolo[3, 4-b]pyrazine derivative its preparation and pharmaceutical compositions containing it | ⤷ Try a Trial |
Norway | 931919 | ⤷ Try a Trial | |
Argentina | 248024 | PREPARACION DEL ISOMERO DEXTROGIRO DE LA (CLORO-5 PIRIDIL-2)-6 (METIL-4 PIPERAZINIL-1) CARBONILOXI-5 OXO-7 HIHIDRO-6, 7 5H-PIRROLO ¡3, 4-B¿PIRAZINA, Y SUS SALES FARMACEUTICAMENTE ACEPTABLES. (OPTICALLY ACTIVE DERIVATIVE OF 5-H-PYRROLO(3,4-B)PYRAZINE, ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |