NDAORALTABLET
Approved
Aug 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
FIBRICOR (fenofibric acid) by Athena Bioscience is delayed-release capsule is fenofibric acid. First approved in 2009.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FIBRICOR (fenofibric acid) is a delayed-release oral capsule approved in 2009 for treating dyslipidemia, particularly elevated triglycerides. It activates peroxisome proliferator-activated receptor α (PPARα) to increase lipolysis, reduce triglyceride-rich particles, and raise HDL cholesterol. The mechanism involves enhanced lipoprotein lipase activity and reduced apolipoprotein CIII production.
LOE Approaching1.2 years to LOE
Product approaching loss of exclusivity in August 2027 with limited commercial runway; team focus shifting toward cost containment and operational efficiency rather than expansion.
Mechanism of Action
delayed-release capsule is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied through oral administration of fenofibrate. The lipid-modifying effects of fenofibric acid seen in clinical practice have been explained in vivo in…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules
Started Feb 2009
32 enrolled
Healthy
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium
Started Dec 2008
90 enrolled
Healthy
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg
Started Nov 2008
90 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.