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BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

NDA

BIVALIRUDIN | N208374 | BAXTER HEALTHCARE CORP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs2 inactive

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

TAPI NL BVBIVALIRUDIN

DMF 208632007

DR REDDYS LABORATORIES LTDBIVALIRUDIN

DMF 236562010

ALP PHARM BEIJING CO LTDBIVALIRUDIN

DMF 242572010

SUN PHARMACEUTICAL INDUSTRIES LTDBIVALIRUDIN

DMF 244232011

CHENGDU SHENGNUO BIOPHARM CO LTDBIVALIRUDIN (NON-STERILE BULK DRUG)

DMF 255312012

SCINOPHARM TAIWAN LTDBIVALIRUDIN

DMF 256342011

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 300712016

SHENZHEN SALUBRIS PHARMACEUTICALS CO LTDBIVALIRUDIN

DMF 302152016

BACHEM AGBIVALIRUDIN

DMF 314582017

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDBIVALIRUDIN

DMF 322812018

POLYPEPTIDE SAInactiveBIVALIRUDIN (TM-001-2G)

DMF 289122014

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDInactiveBIVALIRUDIN (PROCESS II)

DMF 352592020

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 12, 2021	SUPPL -2	View Letter (PDF)
Dec 27, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG/50ML (5MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 21, 2017

No patent or exclusivity listings for this strength.

#002 — 500MG/100ML (5MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Dec 21, 2017