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FDA Orange Book · active-ingredient family

Febuxostat

Febuxostat is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ULORIC · NDA 021856

1

Brand (NDA)

15

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ULORICRLD×2TAKEDA PHARMS USANDA 021856ABFeb 13, 2009

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
FEBUXOSTAT×2LUPINANDA 205406—Jan 17, 2024
FEBUXOSTAT×2TORRENTANDA 211837—Dec 19, 2023
FEBUXOSTAT×2AUROBINDO PHARMA LTDANDA 210741ABOct 25, 2023
FEBUXOSTAT×2MACLEODS PHARMS LTDANDA 207293ABSep 28, 2023
FEBUXOSTAT×2ZYDUS LIFESCIENCESANDA 205443ABJan 09, 2023
FEBUXOSTAT×2PRINSTON INCANDA 206266ABMar 28, 2022
FEBUXOSTAT×2ALKEM LABS LTDANDA 212924ABDec 07, 2021
FEBUXOSTAT×2DR REDDYSANDA 205374ABOct 22, 2020
FEBUXOSTAT×2SUNSHINEANDA 213069ABJun 02, 2020
FEBUXOSTAT×2MSNANDA 210461ABDec 30, 2019
FEBUXOSTAT×2REGCON HOLDINGSANDA 210292ABDec 30, 2019
FEBUXOSTAT×2HIKMAANDA 205414ABOct 15, 2019
FEBUXOSTAT×2ALEMBICANDA 205421ABJul 01, 2019
FEBUXOSTAT×2PHARMOBEDIENTANDA 205385—Jul 01, 2019
FEBUXOSTAT×2SUN PHARMANDA 205467ABJul 01, 2019

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9107912Sep 08, 2031in 5 yr 4 mo
U-1346
8372872Sep 08, 2031in 5 yr 4 mo
U-1346

Febuxostat — 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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