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NEBIVOLOL HYDROCHLORIDE

ANDA

NEBIVOLOL HYDROCHLORIDE | A203825 | HETERO LABS LTD UNIT III

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BYSTOLIC(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Forest Laboratories Inc. et al v. Torrent Pharmaceuticals Ltd. et al 1:2012cv00305 1 patentANDA 203966, 203683, 203659, 203821, 203825nebivolol hydrochloride	D. Del.	2012-03-13	Terminated 2012-06-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 7 NDCs

Highest NADAC/Unit

$0.1839

per ea

Lowest NADAC/Unit

$0.1042

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
31722058830NEBIVOLOL 20 MG TABLET	$0.1839	EA	Generic	—	2026-06-17
31722058890NEBIVOLOL 20 MG TABLET	$0.1839	EA	Generic	—	2026-06-17
31722058730NEBIVOLOL 10 MG TABLET	$0.1474	EA	Generic	—	2026-06-17
31722058790NEBIVOLOL 10 MG TABLET	$0.1474	EA	Generic	—	2026-06-17
31722058530NEBIVOLOL 2.5 MG TABLET	$0.1217	EA	Generic	—	2026-06-17
31722058630NEBIVOLOL 5 MG TABLET	$0.1042	EA	Generic	—	2026-06-17
31722058690NEBIVOLOL 5 MG TABLET	$0.1042	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain13 active DMFs1 inactive

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

CADILA PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 211522007

FIS FABBRICA ITALIANA SINTETICI SPANEBIVOLOL HYDROCHLORIDE

DMF 227352009

TORRENT PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 229062009

MSN PHARMACHEM PRIVATE LTDNEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']

DMF 249162011

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE

DMF 252962011

HONOUR LAB LTDNEBIVOLOL HYDROCHLORIDE

DMF 286272014

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 297302015

MACLEODS PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 299962016

CORDEN PHARMA CHENOVENEBIVOLOL HYDROCHLORIDE

DMF 300522015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 308482016

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE (PROCESS-II)

DMF 310812016

SMAART PHARMACEUTTICALSNEBIVOLOL HYDROCHLORIDE

DMF 353322021

ALKEM LABORATORIES LTDNEBIVOLOL HYDROCHLORIDE

DMF 393132024

DR REDDYS LABORATORIES LTDInactiveNEBIVOLOL HYDROCHLORIDE

DMF 248212011

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

Products (4)

Sort:

#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 3, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 3, 2020

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 3, 2020

#004 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 3, 2020