Viewing data from:

ARGATROBAN IN SODIUM CHLORIDE

NDA

ARGATROBAN | N212035 | ACCORD HEALTHCARE INC

1 strength0 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
EAGLE PHARMACEUTICALS, INC. et al v. ACCORD HEALTHCARE, INC. 2:2019cv09031 2 patentsArgatroban	D.N.J.	2019-03-27	Terminated 2021-03-31	—

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

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 DMFs1 inactive

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

CHEMWERTH INCARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

DMF 207092007

CURIA ITALY SRLARGATROBAN

DMF 207602007

LUNDBECK PHARMACEUTICALS ITALY SPAARGATROBAN

DMF 213042008

GLAND PHARMA LTDARGATROBAN MONOHYDRATE USP

DMF 254002011

EMCURE PHARMACEUTICALS LTDARGATROBAN USP

DMF 257652012

ALP PHARM BEIJING CO LTDARGATROBAN HYDRATE

DMF 258932012

GLAND PHARMA LTDARGATROBAN MONOHYDRATE (PROCESS-II)

DMF 280302014

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDARGATROBAN

DMF 354912020

CURIA ITALY SRLARGATROBAN MONOHYDRATE

DMF 402272024

SUZHOU RYWAY BIOTECH CO LTDARGATROBAN

DMF 424262025

SCINOPHARM TAIWAN LTDInactiveARGATROBAN

DMF 229352009

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -3	View Letter (PDF)
Jun 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/50ML (1MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 7, 2021

No patent or exclusivity listings for this strength.