FDA Orange Book · active-ingredient family
Fenofibrate
Fenofibrate: 7 brands, 48 generics; first approved Dec 31, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 48 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
48
Listed patents
1
Next patent expiry
May 31, 2033
in 6 yr 8 mo
Brand (NDA) products
Originator applications
- LUPINNDA 02169520135 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 43MG CAPSULE ORAL Rx AB 87MG CAPSULE ORAL Discontinued - 130MG CAPSULE ORAL Rx AB 30MG CAPSULE ORAL Discontinued - 90MG CAPSULE ORAL Discontinued - - FENOGLIDERLDSALIXNDA 02211820072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued - 120MG TABLET ORAL Discontinued - - LIPOFENRLDCIPHER PHARMS INCNDA 02161220063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx - 100MG CAPSULE ORAL Discontinued - 150MG CAPSULE ORAL Rx - - TRIGLIDERLDJAGOTECNDA 02135020052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - 160MG TABLET ORAL Discontinued - - TRICORRLDABBVIENDA 02165620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Discontinued - 145MG TABLET ORAL Discontinued - - TRICORRLDABBVIENDA 02120320012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Discontinued - 160MG TABLET ORAL Discontinued - - ABBVIENDA 01930419984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued - 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued -
Generic (ANDA) products (48)
Abbreviated applications
- FENOFIBRATEMACLEODS PHARMSANDA 21037920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATEMACLEODS PHARMSANDA 21024820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEYICHANG HUMANWELLANDA 21854820242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - CHARTWELLANDA 21140720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATECREEKWOOD PHARMSANDA 21773220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - FENOFIBRATEAUROBINDO PHARMAANDA 21679820222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - AUROBINDO PHARMA LTDANDA 21223220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATEBOSTALANDA 20847620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - ALEMBICANDA 21384220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATEMANKIND PHARMAANDA 21386420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATERISINGANDA 21112220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEALEMBICANDA 21325220202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Discontinued - 160MG TABLET ORAL Discontinued - - FENOFIBRATEDR REDDYSANDA 21067020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATEALEMBICANDA 21047620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - INGENUS PHARMS LLCANDA 20756420193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued - - FENOFIBRATECHARTWELL RXANDA 20966020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - AJANTA PHARMA LTDANDA 21070520183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATEPRINSTON INCANDA 21108020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATERISINGANDA 21060620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATEAJANTA PHARMA LTDANDA 21013820182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - TORRENTANDA 21078220183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - ANI PHARMSANDA 20950420183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATEAMNEALANDA 20995020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATEAMNEALANDA 20995120182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEBOSTALANDA 20780320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - REYOUNGANDA 20780520173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - FENOFIBRATESUN PHARMANDA 20088420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Discontinued - 145MG TABLET ORAL Discontinued - - GLENMARK PHARMS LTDANDA 20556620173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Rx AB 134MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - INVAGEN PHARMSANDA 20737820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued - - FENOFIBRATECIPLAANDA 20870920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEHETERO LABS LTD IIIANDA 20459820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEMYLAN PHARMS INCANDA 20447520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - FENOFIBRATEAUROBINDO PHARMAANDA 20511820162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATELUPINANDA 20401920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - SUN PHARM INDS LTDANDA 20174820142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 43MG CAPSULE ORAL Discontinued - 130MG CAPSULE ORAL Discontinued - - APOTEXANDA 20225220132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 43MG CAPSULE ORAL Rx AB 130MG CAPSULE ORAL Rx AB - PHARMOBEDIENTANDA 20257920132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 43MG CAPSULE ORAL Discontinued - 130MG CAPSULE ORAL Discontinued - - FENOFIBRATEMYLAN PHARMS INCANDA 20285620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - RISINGANDA 20267620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued - - FENOFIBRATEBAUSCHANDA 09071520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Discontinued - 145MG TABLET ORAL Discontinued - - CHARTWELL RXANDA 09085920122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 43MG CAPSULE ORAL Rx AB 130MG CAPSULE ORAL Rx AB - FENOFIBRATELUPIN LTDANDA 09085620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 48MG TABLET ORAL Rx AB 145MG TABLET ORAL Rx AB - FENOFIBRATEIMPAX LABSANDA 07650920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - FENOFIBRATEMYLANANDA 07652020073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Discontinued - 107MG TABLET ORAL Discontinued - 160MG TABLET ORAL Discontinued - - FENOFIBRATESUN PHARM INDS LTDANDA 07663520053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Discontinued - 107MG TABLET ORAL Rx - 160MG TABLET ORAL Discontinued - - FENOFIBRATERHODES PHARMSANDA 07643320052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 54MG TABLET ORAL Rx AB 160MG TABLET ORAL Rx AB - IMPAX LABSANDA 07586820033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued - - RHODES PHARMSANDA 07575320023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 67MG CAPSULE ORAL Discontinued - 134MG CAPSULE ORAL Discontinued - 200MG CAPSULE ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9314447 | in 6 yr 8 mo | ProductU-1447 |
Approval history
FDA approval span
First approval
33 yr 3 mo ago
Most recent approval
9 mo ago
Approvals span 1993–2026 across 55 FDA applications.
Brand (NDA) 713%
Generic (ANDA) 4887%
Fenofibrate: 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
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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