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Last Updated: November 21, 2024

ESZOPICLONE - Generic Drug Details

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What are the generic sources for eszopiclone and what is the scope of patent protection?

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 Ltd, Mylan Pharms Inc, Nostrum Labs Inc, Orbion Pharms, Sun Pharm, Teva, and Waylis Therap, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for eszopiclone. Thirty-five suppliers are listed for this compound.

Summary for ESZOPICLONE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	71
Patent Applications:	6,596
Drug Prices:	Drug price trends for ESZOPICLONE
Drug Sales Revenues:	Drug sales revenues for ESZOPICLONE
What excipients (inactive ingredients) are in ESZOPICLONE?	ESZOPICLONE excipients list
DailyMed Link:	ESZOPICLONE at DailyMed

Drug Prices for ESZOPICLONE

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Drug Sales Revenue Trends for ESZOPICLONE

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Recent Clinical Trials for ESZOPICLONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
University of California, Los Angeles	Phase 2
Siriraj Hospital	Phase 4

See all ESZOPICLONE clinical trials

Medical Subject Heading (MeSH) Categories for ESZOPICLONE

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for ESZOPICLONE

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	ESZOPICLONE	eszopiclone	TABLET;ORAL	091166-001	Apr 15, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-001	Dec 15, 2004	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	ESZOPICLONE	eszopiclone	TABLET;ORAL	091169-003	May 23, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ESZOPICLONE	eszopiclone	TABLET;ORAL	091024-003	Apr 15, 2014	AB	RX	No	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
Chartwell Rx	ESZOPICLONE	eszopiclone	TABLET;ORAL	091165-003	Jul 14, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ESZOPICLONE	eszopiclone	TABLET;ORAL	091024-002	Apr 15, 2014	AB	RX	No	No	⤷ 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 ESZOPICLONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
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	021476-002	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

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