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-five 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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Summary for LUNESTA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 46 |
| Patent Applications: | 3,637 |
| 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 |
|---|---|
| American Academy of Sleep Medicine | Phase 2 |
| Laboratorios Andromaco S.A. | Phase 1 |
| University of California, San Diego | Phase 2 |
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 | 021476-001 | Dec 15, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 021476-003 | 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 | 021476-003 | 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 |
|---|---|---|---|
| Norway | 179911 | ⤷ Sign Up | |
| Japan | H06504548 | ⤷ Sign Up | |
| African Intellectual Property Organization (OAPI) | 9807 | ⤷ 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 |
| Australia | 671797 | ⤷ Sign Up | |
| France | 2671800 | DERIVE DE LA 5H-PYRROLO[3,4-B]PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT. | ⤷ Sign Up |
| Philippines | 30982 | Optically active 5H-pyrrolo Ä3,4-bÜ pyrazine derivative, 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.
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