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FDA Orange Book · active-ingredient family

Fenofibrate

Fenofibrate is approved as 7 brand and 48 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ANTARA (MICRONIZED) · NDA 021695

7

Brand (NDA)

48

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
ANTARA (MICRONIZED)RLD×5LUPINNDA 021695—Oct 18, 2013
FENOGLIDERLD×2SALIXNDA 022118—Aug 10, 2007
LIPOFENRLD×3CIPHER PHARMS INCNDA 021612—Jan 11, 2006
TRIGLIDERLD×2JAGOTECNDA 021350—May 07, 2005
TRICORRLD×2ABBVIENDA 021656—Nov 05, 2004
TRICORRLD×2ABBVIENDA 021203—Sep 04, 2001
TRICOR (MICRONIZED)RLD×4ABBVIENDA 019304—Feb 09, 1998

Generic (ANDA) products (48)

ProductApplicantApplicationTEApproved
FENOFIBRATE×2MACLEODS PHARMS LTDANDA 210379ABJan 21, 2026
FENOFIBRATE×2MACLEODS PHARMS LTDANDA 210248ABNov 13, 2024
FENOFIBRATE×2YICHANG HUMANWELLANDA 218548ABApr 24, 2024
FENOFIBRATE (MICRONIZED)×3CHARTWELLANDA 211407ABJan 31, 2024
FENOFIBRATE×2CREEKWOOD PHARMSANDA 217732ABSep 07, 2023
FENOFIBRATE×2AUROBINDO PHARMAANDA 216798ABSep 27, 2022
FENOFIBRATE (MICRONIZED)×3AUROBINDO PHARMA LTDANDA 212232ABSep 20, 2021
FENOFIBRATE×2BOSTALANDA 208476ABFeb 10, 2021
FENOFIBRATE (MICRONIZED)×3ALEMBICANDA 213842ABOct 19, 2020
FENOFIBRATE×2MANKIND PHARMAANDA 213864ABJun 12, 2020
FENOFIBRATE×2RISINGANDA 211122ABMar 18, 2020
FENOFIBRATE×2ALEMBICANDA 213252—Jan 17, 2020
FENOFIBRATE×2DR REDDYSANDA 210670ABSep 06, 2019
FENOFIBRATE×2ALEMBICANDA 210476ABAug 09, 2019
FENOFIBRATE (MICRONIZED)×3INGENUS PHARMS LLCANDA 207564—Apr 19, 2019
FENOFIBRATE×2CHARTWELL RXANDA 209660ABFeb 11, 2019
FENOFIBRATE (MICRONIZED)×3AJANTA PHARMA LTDANDA 210705ABSep 10, 2018
FENOFIBRATE×2PRINSTON INCANDA 211080ABAug 28, 2018
FENOFIBRATE×2RISINGANDA 210606ABAug 17, 2018
FENOFIBRATE×2AJANTA PHARMA LTDANDA 210138ABJul 23, 2018
FENOFIBRATE (MICRONIZED)×3TORRENTANDA 210782ABJun 26, 2018
FENOFIBRATE (MICRONIZED)×3ANI PHARMSANDA 209504ABApr 30, 2018
FENOFIBRATE×2AMNEALANDA 209950ABMar 19, 2018
FENOFIBRATE×2AMNEALANDA 209951ABFeb 09, 2018
FENOFIBRATE×2BOSTALANDA 207803ABDec 19, 2017
FENOFIBRATE (MICRONIZED)×3REYOUNGANDA 207805ABNov 16, 2017
FENOFIBRATE×2SUN PHARMANDA 200884—Sep 07, 2017
FENOFIBRATE (MICRONIZED)×3GLENMARK PHARMS LTDANDA 205566ABApr 07, 2017
FENOFIBRATE (MICRONIZED)×3INVAGEN PHARMSANDA 207378—Mar 28, 2017
FENOFIBRATE×2CIPLAANDA 208709ABDec 15, 2016
FENOFIBRATE×2HETERO LABS LTD IIIANDA 204598ABJul 12, 2016
FENOFIBRATE×2MYLAN PHARMS INCANDA 204475ABJun 23, 2016
FENOFIBRATE×2AUROBINDO PHARMAANDA 205118ABMay 05, 2016
FENOFIBRATE×2LUPINANDA 204019ABAug 17, 2015
FENOFIBRATE (MICRONIZED)×2SUN PHARM INDS LTDANDA 201748—Oct 31, 2014
FENOFIBRATE (MICRONIZED)×2APOTEXANDA 202252ABJul 26, 2013
FENOFIBRATE (MICRONIZED)×2PHARMOBEDIENTANDA 202579—Jan 10, 2013
FENOFIBRATE×2MYLAN PHARMS INCANDA 202856ABDec 07, 2012
FENOFIBRATE (MICRONIZED)×3RISINGANDA 202676—Oct 23, 2012
FENOFIBRATE×2BAUSCHANDA 090715—Apr 05, 2012
FENOFIBRATE (MICRONIZED)×2CHARTWELL RXANDA 090859ABMar 01, 2012
FENOFIBRATE×2LUPIN LTDANDA 090856ABDec 23, 2011
FENOFIBRATE×2IMPAX LABSANDA 076509ABMar 26, 2008
FENOFIBRATE×3MYLANANDA 076520—Oct 25, 2007
FENOFIBRATE×3SUN PHARM INDS LTDANDA 076635—Oct 31, 2005
FENOFIBRATE×2RHODES PHARMSANDA 076433ABMay 13, 2005
FENOFIBRATE (MICRONIZED)×3IMPAX LABSANDA 075868—Oct 27, 2003
FENOFIBRATE (MICRONIZED)×3RHODES PHARMSANDA 075753ABSep 03, 2002

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9314447May 31, 2033in 7 yr 1 mo
ProductU-1447

Fenofibrate — frequently asked questions

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

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