Viewing data from:

LUNESTA

NDA

ESZOPICLONE | N021476 | WAYLIS THERAPEUTICS LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lunesta (2023)

Total Spending

$5.9M

Total Claims

7,117

Beneficiaries

1,180

Avg Cost/Unit

$22.44

Spending Trend

$6.5M(2019)→$5.7M(2020)→$5.5M(2021)→$4.9M(2022)→$5.9M(2023)

YoY Change:+39.7%

5yr CAGR:+9.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs7 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDESZOPICLONE USP

DMF 214792008

TIANJIN TASLY SANTS PHARMACEUTICAL CO LTDESZOPICLONE

DMF 217152008

ALIVUS LIFE SCIENCES LTDESZOPICLONE USP

DMF 218532008

DR REDDYS LABORATORIES LTDESZOPICLONE USP

DMF 219762008

ORBION PHARMACEUTICALS PRIVATE LTDESZOPICLONE (NON-STERILE BULK API)

DMF 220712008

SUN PHARMACEUTICAL INDUSTRIES LTDESZOPICLONE

DMF 221292008

WOCKHARDT LTDESZOPICLONE

DMF 221642008

TAPI NL BVESZOPICLONE ( PROCESS I )

DMF 222032008

LUPIN LTDESZOPICLONE USP

DMF 222972008

MACLEODS PHARMACEUTICALS LTDESZOPICLONE USP

DMF 243262010

EMCURE PHARMACEUTICALS LTDESZOPICLONE USP

DMF 246552011

TAPI NL BVESZOPICLONE (PROCESS II)

DMF 277052014

SYMED LABS LTDESZOPICLONE

DMF 281712014

CALYX CHEMICALS AND PHARMACEUTICALS LTDESZOPICLONE

DMF 383662023

R L FINE CHEM PVT LTDESZOPICLONE

DMF 415892025

FARMAK ASInactiveESZOPICLONE

DMF 214122008

ALP PHARM BEIJING CO LTDInactiveESZOPICLONE

DMF 234242009

UNIMARK REMEDIES LTDInactiveESZOPICLONE

DMF 234762010

RELIANCE LIFE SCIENCES PVT LTDInactiveESZOPICLONE

DMF 238092010

ESTEVE QUIMICA SAInactiveESZOPICLONE

DMF 248632011

APOTEX PHARMACHEM INDIA PVT LTDInactiveESZOPICLONE USP

DMF 268292013

DR REDDYS LABORATORIES LTDInactiveESZOPICLONE [PROCESS-3]

DMF 271662013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Feb 3, 2020	SUPPL -38	View Letter (PDF)
Feb 14, 2019	SUPPL -37	View Letter (PDF)
Nov 15, 2018	SUPPL -36	View Letter (PDF)
May 20, 2014	SUPPL -30	View Letter (PDF)
Feb 10, 2014	SUPPL -28	View Letter (PDF)
Oct 12, 2012	SUPPL -26	View Letter (PDF)
Oct 12, 2012	SUPPL -24	View Letter (PDF)
Jan 31, 2012	SUPPL -21	View Letter (PDF)
Apr 10, 2009	SUPPL -12	View Letter (PDF)
Jan 30, 2008	SUPPL -8	View Letter (PDF)
Jan 30, 2008	SUPPL -5	View Letter (PDF)
Dec 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 15, 2004

No patent or exclusivity listings for this strength.

#002 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 15, 2004

#003 — 3MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 15, 2004