FDA Orange Book · active-ingredient family
Choline fenofibrate
Choline fenofibrate is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TRILIPIX · NDA 022224
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRILIPIXRLD×2 | ABBVIE | NDA 022224 | — | Dec 15, 2008 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FENOFIBRIC ACID×2 | MACLEODS PHARMS LTD | ANDA 207796 | — | Feb 08, 2024 | |
| FENOFIBRIC ACID×2 | YICHANG HUMANWELL | ANDA 212562 | AB | Dec 23, 2020 | |
| FENOFIBRIC ACID×2 | MICRO LABS | ANDA 213450 | AB | Jun 16, 2020 | |
| FENOFIBRIC ACID×2 | AUROBINDO PHARMA LTD | ANDA 212598 | AB | Jul 25, 2019 | |
| FENOFIBRIC ACID×2 | RISING | ANDA 211626 | AB | Jul 18, 2019 | |
| FENOFIBRIC ACID×2 | TWI PHARMS | ANDA 210469 | — | Jul 05, 2019 | |
| FENOFIBRIC ACID×2 | ALEMBIC | ANDA 208705 | AB | May 12, 2017 | |
| FENOFIBRIC ACID×2 | IMPAX LABS INC | ANDA 200264 | AB | Sep 07, 2016 | |
| FENOFIBRIC ACID×2 | ACTAVIS ELIZABETH | ANDA 200920 | AB | Oct 07, 2015 | |
| FENOFIBRIC ACID×2 | CHARTWELL RX | ANDA 200750 | AB | Dec 04, 2013 | |
| FENOFIBRIC ACID×2 | PH HEALTH | ANDA 201573 | — | Jul 18, 2013 | |
| FENOFIBRIC ACID×2 | PHARMOBEDIENT | ANDA 200913 | — | Mar 25, 2013 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Choline fenofibrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
