Is there a generic for Argatroban?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Argatroban, referencing the brand ARGATROBAN IN SODIUM CHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Argatroban?

ARGATROBAN IN SODIUM CHLORIDE (NDA 212035, ACCORD HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Argatroban?

The Orange Book lists 2 patents against Argatroban products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Argatroban are approved?

Argatroban is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Argatroban

Argatroban: 9 brands, 7 generics; first approved Jun 30, 2000; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 7 ANDA applications approved.

Earliest patent expiry Sep 26, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 26, 2027

in 1 yr 3 mo

Originator applications

Brand (NDA) products

ARGATROBAN IN SODIUM CHLORIDERLDRS

ACCORD HLTHCARENDA 2120352021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/50ML (1MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

ARGATROBANRLDRS

HIKMA PHARM CO LTDNDA 20304920162 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Rx	AP
50MG/50ML (1MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN IN SODIUM CHLORIDERLD

CIPLANDA 0224342011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/50ML (1MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INTRAVENOUS	Discontinued	—

ARGATROBAN IN SODIUM CHLORIDERLDRS

PLANO PHARMSNDA 0224852011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG/125ML (1MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

ARGATROBANRLD

SANDOZNDA 0208832000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Discontinued	—

ARGATROBAN IN SODIUM CHLORIDE

EUGIA PHARMA SPECLTSNDA 2095522018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/50ML (1MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

ARGATROBAN

FRESENIUS KABI USANDA 2018112015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Discontinued	—

ARGATROBAN IN 0.9% SODIUM CHLORIDE

TEVA PHARMS USANDA 2067692014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/250ML (1MG/ML)	INJECTABLE	INTRAVENOUS	Discontinued	—

ARGATROBAN IN DEXTROSE

SANDOZNDA 2017432011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG/125ML (1MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

Abbreviated applications

Generic (ANDA) products (7)

ARGATROBAN

GLANDANDA 2178482023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/50ML (1MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN

CAPLINANDA 2142352021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/50ML (1MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN

AMNEAL PHARMS COANDA 2066982018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN IN SODIUM CHLORIDE

GLANDANDA 2055702017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
125MG/125ML (1MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

ARGATROBANRS

HOSPIRAANDA 2041202016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN

MYLAN INSTITUTIONALANDA 2026262014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Rx	AP

ARGATROBAN

PH HEALTHANDA 0916652014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG/2.5ML (100MG/ML)	INJECTABLE	INJECTION	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7687516	Sep 26, 2027	in 1 yr 3 mo	ProductU-1164
7589106	Sep 26, 2027	in 1 yr 3 mo	ProductU-1163

FDA approval span

Approval history

First approval

Jun 30, 2000

26 yr 5 mo ago

Most recent approval

Jul 31, 2023

3 yr ago

Approvals span 2000–2023 across 16 FDA applications.

Brand (NDA) 956%

Generic (ANDA) 744%

Argatroban — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo