Viewing data from:

TRILIPIX

NDA

CHOLINE FENOFIBRATE | N022224 | ABBVIE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Trilipix (2023)

Total Spending

$307K

Total Claims

523

Beneficiaries

127

Avg Cost/Unit

$8.63

Spending Trend

$698K(2019)→$571K(2020)→$413K(2021)→$327K(2022)→$307K(2023)

YoY Change:+5.0%

5yr CAGR:+2.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

CORDEN PHARMA CHENOVECHOLINE FENOFIBRATE DRUG SUBSTANCE

DMF 209502007

OLON SPACHOLINE FENOFIBRATE

DMF 232682009

CURIA MISSOURI INCCHOLINE FENOFIBRATE

DMF 233902009

OLON SPACHOLINE FENOFIBRATE

DMF 234642010

ALIVUS LIFE SCIENCES LTDCHOLINE FENOFIBRATE

DMF 245242011

MOEHS IBERICA SLCHOLINE FENOFIBRATE

DMF 245402011

HARMAN FINOCHEM LTDCHOLINE FENOFIBRATE

DMF 282822014

ABBVIE INCInactiveCHOLINE FENOFIBRATE DRUG SUBSTANCE

DMF 208952007

ABBVIE INCInactiveCHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATE

DMF 208962007

LUPIN LTDInactiveCHOLINE FENOFIBRATE

DMF 230482009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2025	SUPPL -18	View Letter (PDF)
Jun 7, 2021	SUPPL -17	View Letter (PDF)
Jun 7, 2021	SUPPL -16	View Letter (PDF)
Mar 29, 2019	SUPPL -15	View Letter (PDF)
Nov 15, 2018	SUPPL -14	View Letter (PDF)
May 21, 2018	SUPPL -13	View Letter (PDF)
Apr 28, 2015	SUPPL -11	View Letter (PDF)
Sep 14, 2012	SUPPL -7	View Letter (PDF)
Sep 14, 2012	SUPPL -8	View Letter (PDF)
Oct 3, 2011	SUPPL -5	View Letter (PDF)
Oct 3, 2011	SUPPL -6	View Letter (PDF)
Mar 16, 2011	SUPPL -4	View Letter (PDF)
Sep 16, 2010	SUPPL -3	View Letter (PDF)
Dec 19, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 45MG FENOFIBRIC ACID

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Dec 15, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 135MG FENOFIBRIC ACID

RLD

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Dec 15, 2008