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FDA Orange Book · active-ingredient family

Argatroban

Argatroban is approved as 9 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARGATROBAN IN SODIUM CHLORIDE · NDA 212035

9

Brand (NDA)

7

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
ARGATROBAN IN SODIUM CHLORIDERLDACCORD HLTHCARENDA 212035—Jun 07, 2021
ARGATROBANRLD×2HIKMA PHARM CO LTDNDA 203049APSep 30, 2016
ARGATROBAN IN SODIUM CHLORIDERLDCIPLANDA 022434—Jun 29, 2011
ARGATROBAN IN SODIUM CHLORIDERLDPLANO PHARMSNDA 022485APMay 09, 2011
ARGATROBANRLDSANDOZNDA 020883—Jun 30, 2000
ARGATROBAN IN SODIUM CHLORIDEEUGIA PHARMA SPECLTSNDA 209552—Nov 27, 2018
ARGATROBANFRESENIUS KABI USANDA 201811—Mar 23, 2015
ARGATROBAN IN 0.9% SODIUM CHLORIDETEVA PHARMS USANDA 206769—Dec 15, 2014
ARGATROBAN IN DEXTROSESANDOZNDA 201743—May 09, 2011

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
ARGATROBANGLANDANDA 217848APJul 31, 2023
ARGATROBANCAPLINANDA 214235APJan 21, 2021
ARGATROBANAMNEAL PHARMS COANDA 206698APJan 26, 2018
ARGATROBAN IN SODIUM CHLORIDEGLANDANDA 205570APMay 22, 2017
ARGATROBANHOSPIRAANDA 204120APSep 21, 2016
ARGATROBANMYLAN INSTITUTIONALANDA 202626APJun 30, 2014
ARGATROBANPH HEALTHANDA 091665APJun 30, 2014

Listed patents (2)

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

Argatroban — frequently asked questions

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

Agent CTA Background

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