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FDA Orange Book · active-ingredient family

Bivalirudin

Bivalirudin is approved as 3 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ANGIOMAX RTU · NDA 211215

3

Brand (NDA)

11

Generics (ANDA)

8

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
ANGIOMAX RTURLDMAIA PHARMS INCNDA 211215—Jul 25, 2019
BIVALIRUDIN IN 0.9% SODIUM CHLORIDERLD×2BAXTER HLTHCARE CORPNDA 208374—Dec 21, 2017
ANGIOMAXRLDSANDOZNDA 020873APDec 15, 2000

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
BIVALIRUDINSLATE RUN PHARMAANDA 213078APMay 28, 2021
BIVALIRUDINSHUANGCHENGANDA 210031APOct 23, 2019
BIVALIRUDINEUGIA PHARMAANDA 205962—Jul 27, 2018
BIVALIRUDINMEITHEALANDA 091602APJul 16, 2018
BIVALIRUDINMYLAN INSTITUTIONALANDA 202471APJun 01, 2018
BIVALIRUDINACCORD HLTHCAREANDA 206551APNov 22, 2017
BIVALIRUDINAPOTEXANDA 204876—Jul 06, 2017
BIVALIRUDINDR REDDYSANDA 201577APMay 26, 2017
BIVALIRUDINFRESENIUS KABI USAANDA 090189APOct 28, 2016
BIVALIRUDINHOSPIRAANDA 090811—Jul 14, 2015
BIVALIRUDINHOSPIRAANDA 090816—Jul 14, 2015

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7582727Jul 27, 2028in 2 yr 2 mo
Product
7598343Jul 27, 2028in 2 yr 2 mo
Product
7582727*PEDJan 27, 2029in 2 yr 8 mo
7598343*PEDJan 27, 2029in 2 yr 8 mo
11903993May 20, 2039in 13 yr 1 mo
U-3817
12472224May 20, 2039in 13 yr 1 mo
ProductU-3817
11918622May 20, 2039in 13 yr 1 mo
U-3817
11992514May 20, 2039in 13 yr 1 mo
Product

Bivalirudin — 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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