eszopiclone - Profile

What are the generic drug sources for eszopiclone and what is the scope of freedom to operate?

Eszopiclone is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hikma, Ipca Labs Ltd, Lupin Ltd, Macleods Pharms, Mylan Pharms Inc, Orbion Pharms, Pharmobedient, Sun Pharm, Teva, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for eszopiclone

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15

Paragraph IV (Patent) Challenges for ESZOPICLONE

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 eszopiclone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	ESZOPICLONE	eszopiclone	TABLET;ORAL	208451-001	Sep 15, 2016	AB	RX	No	No
Aurobindo Pharma	ESZOPICLONE	eszopiclone	TABLET;ORAL	208451-002	Sep 15, 2016	AB	RX	No	No
Aurobindo Pharma	ESZOPICLONE	eszopiclone	TABLET;ORAL	208451-003	Sep 15, 2016	AB	RX	No	No
Chartwell Rx	ESZOPICLONE	eszopiclone	TABLET;ORAL	091165-001	Jul 14, 2011		DISCN	No	No
Chartwell Rx	ESZOPICLONE	eszopiclone	TABLET;ORAL	091165-002	Jul 14, 2011		DISCN	No	No
Chartwell Rx	ESZOPICLONE	eszopiclone	TABLET;ORAL	091165-003	Jul 14, 2011		DISCN	No	No
Dr Reddys	ESZOPICLONE	eszopiclone	TABLET;ORAL	091024-001	Apr 15, 2014	AB	RX	No	No