FDA Orange Book
Generic for Trilipix
Trilipix contains choline fenofibrate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Trilipix is choline fenofibrate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Trilipix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | EQ 135MG FENOFIBRIC ACID | Discontinued | None | 7 | AB |
| capsule, delayed release, oral | EQ 45MG FENOFIBRIC ACID | Discontinued | None | 7 | AB |
NDA 022224, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic choline fenofibrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL RX SCIENCES LLC | 200750 | AB (A-rated, therapeutically equivalent) | December 4, 2013 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| ACTAVIS ELIZABETH LLC | 200920 | AB (A-rated, therapeutically equivalent) | October 7, 2015 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| IMPAX LABORATORIES INC | 200264 | AB (A-rated, therapeutically equivalent) | September 7, 2016 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| ALEMBIC PHARMACEUTICALS LTD | 208705 | AB (A-rated, therapeutically equivalent) | May 12, 2017 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| RISING PHARMA HOLDINGS INC | 211626 | AB (A-rated, therapeutically equivalent) | July 18, 2019 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| AUROBINDO PHARMA LTD | 212598 | AB (A-rated, therapeutically equivalent) | July 25, 2019 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 212562 | AB (A-rated, therapeutically equivalent) | December 23, 2020 | EQ 135MG FENOFIBRIC ACID, EQ 45MG FENOFIBRIC ACID |
Questions
Is there a generic for Trilipix?
Yes. The generic name for Trilipix is choline fenofibrate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Trilipix?
The active ingredient in Trilipix is choline fenofibrate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.