Viewing data from:

ESZOPICLONE

ANDA

ESZOPICLONE | A091113 | ORBION PHARMACEUTICALS PRIVATE LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LUNESTA(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.0932

per ea

Lowest NADAC/Unit

$0.0873

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
69452034820ESZOPICLONE 2 MG TABLET	$0.0932	EA	Generic	—	2026-06-17
69452034713ESZOPICLONE 1 MG TABLET	$0.0914	EA	Generic	—	2026-06-17
69452034920ESZOPICLONE 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.

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.

Products (3)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 10, 2014

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 10, 2014

#003 — 3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 10, 2014