ESZOPICLONE | A091024 | DR REDDYS LABORATORIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a | Other | 2015-12-16 | Open | Daniel F. Kripke, MD (The Weston Firm) |
Sunovion Pharmaceuticals, Inc (Covington & Burling) - Citizen Petition FDA-2012-P-0943 · 3 docket documents Sunovion Pharmaceuticals, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act on August 29, 2012, requesting that the FDA refuse to approve Dr. Reddy's Laboratories ANDA No. 91024 for generic eszopiclone tablets citing Sunovion's Lunesta as the reference | 505(q) | 2012-09-04 | Denied | — |
Sepracor, Inc. - Citizen Petition FDA-2006-P-0137 · 7 docket documents Sepracor Inc. filed this citizen petition on December 30, 2005, requesting that the FDA Commissioner confirm that the approval of the NDA for Lunesta (eszopiclone) tablets became effective on April 4, 2005 (the date of DEA scheduling completion), rather than December 15, 2004 (the date of the approv | 505(q) | 2008-08-20 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0932
per ea
Lowest NADAC/Unit
$0.0873
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55111061901ESZOPICLONE 2 MG TABLET | $0.0932 | EA | Generic | — | 2026-06-17 |
| 55111062930ESZOPICLONE 1 MG TABLET | $0.0914 | EA | Generic | — | 2026-06-17 |
| 55111061701ESZOPICLONE 3 MG TABLET | $0.0873 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.