LUNESTA Drug Patent Profile

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 23^rd, 2011.

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

See drug prices for LUNESTA

See drug sales revenues for LUNESTA

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

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
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004	AB	RX	Yes	No
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	AB	RX	Yes	Yes

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
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-002	Dec 15, 2004

International Patents for LUNESTA

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

Country	Patent Number	Title	Estimated Expiration
Germany	69202060
Tunisia	SN92004	DERIVE DE LA 5H-PYRROLO (3,4-B) PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT
Slovakia	71993	OPTICALY ACTIVE 5H-PYRROLO[3,4-B]PYRAZINE DERIVATIVE, ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME
Czech Republic	9301380
World Intellectual Property Organization (WIPO)	9212980
Canada	2099782	DERIVE DE LA 5H-PYRROLO[3,4-B] PYRAZINE OPTIQUEMENT ACTIF, SA PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LE CONTIENNENT (OPTICALLY ACTIVE 5H-PYRROLO[3,4-B] PYRAZINE, PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTANING SAME)