FDA Orange Book · active-ingredient family
Eszopiclone
Eszopiclone is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LUNESTA · NDA 021476
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUNESTARLD×3 | WAYLIS THERAP | NDA 021476 | AB | Dec 15, 2004 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESZOPICLONE×3 | HETERO LABS LTD V | ANDA 205504 | AB | Jan 04, 2024 | |
| ESZOPICLONE×3 | IPCA LABS LTD | ANDA 206222 | — | Dec 29, 2023 | |
| ESZOPICLONE×3 | PHARMOBEDIENT | ANDA 203087 | — | May 08, 2019 | |
| ESZOPICLONE×3 | AUROBINDO PHARMA | ANDA 208451 | AB | Sep 15, 2016 | |
| ESZOPICLONE×3 | MACLEODS PHARMS LTD | ANDA 202929 | AB | Jan 30, 2015 | |
| ESZOPICLONE×3 | ORBION PHARMS | ANDA 091113 | AB | Jun 10, 2014 | |
| ESZOPICLONE×3 | DR REDDYS | ANDA 091024 | AB | Apr 15, 2014 | |
| ESZOPICLONE×3 | GLENMARK PHARMS LTD | ANDA 091166 | AB | Apr 15, 2014 | |
| ESZOPICLONE×3 | HIKMA | ANDA 091153 | — | Apr 15, 2014 | |
| ESZOPICLONE×3 | SUN PHARM | ANDA 091103 | AB | Apr 03, 2013 | |
| ESZOPICLONE×3 | MYLAN PHARMS INC | ANDA 091151 | AB | Mar 26, 2013 | |
| ESZOPICLONE×3 | LUPIN LTD | ANDA 091124 | — | Sep 13, 2011 | |
| ESZOPICLONE×3 | CHARTWELL RX | ANDA 091165 | — | Jul 14, 2011 | |
| ESZOPICLONE×3 | TEVA | ANDA 091169 | AB | May 23, 2011 |
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.
Eszopiclone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
