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)
1
Generics (ANDA)
14
Listed patents
0
Presentations
45
Brand (NDA) products
Originator applications
- LUNESTARLDWAYLIS 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
Generic (ANDA) products (14)
Abbreviated applications
- ESZOPICLONEHETERO 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 - ESZOPICLONEIPCA 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 — - ESZOPICLONEPHARMOBEDIENTANDA 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 — - ESZOPICLONEAUROBINDO 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 - ESZOPICLONEMACLEODS PHARMSANDA 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 - ESZOPICLONEORBION 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 - ESZOPICLONEDR 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 - ESZOPICLONEGLENMARK 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 - ESZOPICLONEHIKMAANDA 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 — - ESZOPICLONESUN 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 - ESZOPICLONEMYLAN 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 - ESZOPICLONELUPIN 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 — - ESZOPICLONECHARTWELL 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 — - ESZOPICLONETEVAANDA 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
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
22 yr 2 mo ago
Most recent approval
2 yr 10 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
