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NEBIVOLOL HYDROCHLORIDE

ANDA

NEBIVOLOL HYDROCHLORIDE | A203741 | ALKEM LABORATORIES LTD

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Forest Laboratories, Inc. et al v. Indchemie Health Specialties PVT. LTD. et al 1:2012cv01855 1 patentANDA 203828, 203741nebivolol hydrochloride	N.D. Ill.	2012-03-14	Terminated 2013-12-19	—

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

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 26, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 24, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 24, 2015

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 24, 2015

#004 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 24, 2015