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BREXPIPRAZOLE

ANDA

BREXPIPRAZOLE | A213562 | AMNEAL EU LTD

6 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Otsuka Pharmaceutical Co., Ltd. et al v. Amneal Pharmaceuticals LLC et al 1:2020cv01297 6 patentsANDA 213562brexpiprazole	D. Del.	2020-09-25	Terminated 2022-08-17	—

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

API Supply Chain21 active DMFs

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

MSN LIFE SCIENCES PRIVATE LTDBREXPIPRAZOLE

DMF 321422017

ZAKLADY FARMACEUTYCZNE POLPHARMA SABREXPIPRAZOLE

DMF 323472017

HONOUR LAB LTDBREXPIPRAZOLE

DMF 325322018

JUBILANT PHARMOVA LTDBREXPIPRAZOLE

DMF 329952018

ALEMBIC PHARMACEUTICALS LTDBREXPIPRAZOLE

DMF 331222018

SCINOPHARM TAIWAN LTDBREXPIPRAZOLE

DMF 332312018

ZYDUS LIFESCIENCES LTDBREXPIPRAZOLE

DMF 332842018

LUPIN LTDBREXPIPRAZOLE

DMF 334212019

UNICHEM LABORATORIES LTDBREXPIPRAZOLE

DMF 334372019

TAPI NL BVBREXPIPRAZOLE

DMF 334502019

RAKS PHARMA PVT LTDBREXPIPRAZOLE

DMF 334512018

MACLEODS PHARMACEUTICALS LTDBREXPIPRAZOLE

DMF 334822019

SIGNA SA DE CVBREXPIPRAZOLE

DMF 335602019

APITORIA PHARMA PRIVATE LTDBREXPIPRAZOLE

DMF 335722019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDBREXPIPRAZOLE

DMF 337042019

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDBREXPIPRAZOLE

DMF 338102019

TOPHARMAN SHANDONG CO LTDBREXPIPRAZOLE

DMF 363602022

CIPLA LTDBREXPIPRAZOLE

DMF 383262023

BEIJING HOPE PHARMACEUTICAL CO LTDBREXPIPRAZOLE

DMF 394482024

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDBREXPIPRAZOLE

DMF 397402024

MOREPEN LABORATORIES LTDBREXPIPRAZOLE

DMF 404992024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.