Viewing data from:

ESZOPICLONE

ANDA

ESZOPICLONE | A091024 | DR REDDYS LABORATORIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LUNESTA(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Eszopiclone (2023)

Total Spending

$25.8M

Total Claims

641,925

Beneficiaries

149,281

Avg Cost/Unit

$1.09

Spending Trend

$21.6M(2019)→$18.5M(2020)→$20.6M(2021)→$25.5M(2022)→$25.8M(2023)

YoY Change:+2.4%

5yr CAGR:-2.4%

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

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 15, 2014

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2014

#003 — 3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2014