FDA Orange Book

Generic for Lunesta

Lunesta contains eszopiclone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Lunesta is eszopiclone. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Lunesta products in the Orange Book

Lunesta products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	1MG	Marketed (Rx)	AB	9	AB
tablet, oral	2MG	Marketed (Rx)	AB	9	AB
tablet, oral	3MG	Marketed (Rx)	AB	9	AB

NDA 021476, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic eszopiclone

Approved generic versions of Lunesta
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	091169	AB (A-rated, therapeutically equivalent)	May 23, 2011	1MG, 2MG, 3MG
MYLAN PHARMACEUTICALS INC	091151	AB (A-rated, therapeutically equivalent)	March 26, 2013	1MG, 2MG, 3MG
SUN PHARMACEUTICAL INDUSTRIES LTD	091103	AB (A-rated, therapeutically equivalent)	April 3, 2013	1MG, 2MG, 3MG
DR REDDYS LABORATORIES LTD	091024	AB (A-rated, therapeutically equivalent)	April 15, 2014	1MG, 2MG, 3MG
GLENMARK PHARMACEUTICALS LTD	091166	AB (A-rated, therapeutically equivalent)	April 15, 2014	1MG, 2MG, 3MG
ORBION PHARMACEUTICALS PRIVATE LTD	091113	AB (A-rated, therapeutically equivalent)	June 10, 2014	1MG, 2MG, 3MG
MACLEODS PHARMACEUTICALS LTD	202929	AB (A-rated, therapeutically equivalent)	January 30, 2015	1MG, 2MG, 3MG
AUROBINDO PHARMA LTD	208451	AB (A-rated, therapeutically equivalent)	September 15, 2016	1MG, 2MG, 3MG
HETERO LABS LTD UNIT V	205504	AB (A-rated, therapeutically equivalent)	January 4, 2024	1MG, 2MG, 3MG

Lunesta NDC codes

Questions

Is there a generic for Lunesta?

Yes. The generic name for Lunesta is eszopiclone. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Lunesta?

The active ingredient in Lunesta is eszopiclone, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.