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IVABRADINE HYDROCHLORIDE

ANDA

IVABRADINE HYDROCHLORIDE | A213442 | ZYDUS PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AMGEN INC. et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 3:2020cv00678 4 patentsANDA 213442ivabradine	D.N.J.	2020-01-21	Terminated 2020-05-08	—

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

API Supply Chain10 active DMFs

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

ORIL INDUSTRIEIVABRADINE HYDROCHLORIDE

DMF 279792014

BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTDIVABRADINE HYDROCHLORIDE

DMF 286582014

ALEMBIC PHARMACEUTICALS LTDIVABRADINE HYDROCHLORIDE

DMF 320742017

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 326162019

BIONPHARMA INCIVABRADINE HYDROCHLORIDE

DMF 330772018

ZYDUS LIFESCIENCES LTDIVABRADINE HYDROCHLORIDE

DMF 331072018

URQUIMA SAIVABRADINE HYDROCHLORIDE (FORM IV)

DMF 332132018

MAITHRI LABORATORIES PRIVATE LTDIVABRADINE HYDROCHLORIDE

DMF 332462018

HETERO DRUGS LTDIVABRADINE HYDROCHLORIDE

DMF 333682018

FUXIN LONG RUI PHARMACEUTICAL CO LTDIVABRADINE HYDROCHLORIDE

DMF 333772018

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

Products (2)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 29, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 7.5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2023