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BIVALIRUDIN

ANDA

BIVALIRUDIN | A204876 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
THE MEDICINES COMPANY v. APOTEX INC. et al 3:2013cv02801 2 patentsANDA 204876bivalirudin	D.N.J.	2013-05-01	Terminated 2018-05-02	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Jul 11, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Jul 6, 2017

No patent or exclusivity listings for this strength.