Is there a generic for Eszopiclone?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Eszopiclone, referencing the brand LUNESTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Eszopiclone?

LUNESTA (NDA 021476, WAYLIS THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Eszopiclone are approved?

Eszopiclone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Eszopiclone

Eszopiclone: 1 brand, 14 generics; first approved Dec 15, 2004; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 14 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

LUNESTARLD

WAYLIS THERAPNDA 02147620043 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (14)

ESZOPICLONE

HETERO LABS LTD VANDA 20550420243 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

IPCA LABS LTDANDA 20622220233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
3MG	TABLET	ORAL	Discontinued	—

ESZOPICLONE

PHARMOBEDIENTANDA 20308720193 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
3MG	TABLET	ORAL	Discontinued	—

ESZOPICLONE

AUROBINDO PHARMAANDA 20845120163 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

MACLEODS PHARMS LTDANDA 20292920153 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

ORBION PHARMSANDA 09111320143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

DR REDDYSANDA 09102420143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

GLENMARK PHARMS LTDANDA 09116620143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

HIKMAANDA 09115320143 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
3MG	TABLET	ORAL	Discontinued	—

ESZOPICLONE

SUN PHARMANDA 09110320133 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

MYLAN PHARMS INCANDA 09115120133 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

ESZOPICLONE

LUPIN LTDANDA 09112420113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
3MG	TABLET	ORAL	Discontinued	—

ESZOPICLONE

CHARTWELL RXANDA 09116520113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—
3MG	TABLET	ORAL	Discontinued	—

ESZOPICLONE

TEVAANDA 09116920113 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB
3MG	TABLET	ORAL	Rx	AB

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Dec 15, 2004

21 yr 11 mo ago

Most recent approval

Jan 04, 2024

2 yr 7 mo ago

Approvals span 2004–2024 across 15 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1493%

Eszopiclone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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