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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for LUNESTA?
- What are the global sales for LUNESTA?
- What is Average Wholesale Price for LUNESTA?
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 |
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 |
![LUNESTA drug patent expirations Drug patent expirations by year for LUNESTA](/p/graph/s/t/LUNESTA-patent-expirations.png)
![Drug Prices for LUNESTA](/p/graph/drug-price/LUNESTA.png)
![Drug Sales Revenue Trends for LUNESTA](/p/graph/drug-sales-revenues/LUNESTA.png)
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 | 021476-002 | Dec 15, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Waylis Therap | LUNESTA | eszopiclone | TABLET;ORAL | 021476-001 | 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 |
>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 |
---|---|---|---|
Hungary | 218928 | Optikailag aktív zopiclone, eljárás előállítására és az ezt tartalmazó gyógyszerkészítmény (OPTICALLY ACTIVE ZOPICLONE, PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITION CONTAINING SAME) | ⤷ Sign Up |
Israel | 100677 | Dextrorotatory zopiclone its preparation and pharmaceutical compositions containing it | ⤷ Sign Up |
Slovakia | 71993 | OPTICALY ACTIVE 5H-PYRROLO[3,4-B]PYRAZINE DERIVATIVE, ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME | ⤷ Sign Up |
Yugoslavia | 5592 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |