Prescription medicine
Fenofibric acid First approved as Trilipix
Fenofibric acid (Trilipix) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.286 per fenofibric acid DR 135 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fenofibric acid FDA label on DailyMed (effective August 2, 2025, Aurobindo Pharma Limited); the NDA 22224 record on Drugs@FDA; every fenofibric acid label on DailyMed.
Highlights of the record
FDA label of August 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).
Forms and strengths
- 45 mg
- 135 mg
Delayed-release capsule.
On the market
- Earliest approval on file
- December 15, 2008 Trilipix, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first March 25, 2013; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 7 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- August 20, 2027 Fibricor tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.286 per capsule Fenofibric acid DR 135 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest October 1, 2015
- FAERS reports
- 776 through July 30, 2026
What is fenofibric acid used for?
From the label: indications and usageFenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet: to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7) ]. […]
Conditions named in the indications of fenofibric acid's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist.
Source: FDA drug label (FENOFIBRIC ACID), Aurobindo Pharma Limited, effective August 2, 2025 (SPL set 9ad201de-fa62-4c49-bc61-ee09b9ba434c), via openFDA; the full label on DailyMed
Is there a generic for fenofibric acid (Trilipix)?
The FDA approved the first generic fenofibric acid on March 25, 2013. 12 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fenofibric acid from 7 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Trilipix capsules; a patent listed only for Fibricor tablets runs to August 20, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2013 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fenofibric acid (Trilipix)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.286 per Fenofibric acid DR 135 mg capsule, up 4% from $0.276 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fenofibric acid DR 135 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fenofibric acid DR 135 mg capsule | Generic | $0.286 per capsule | $8.59 | +4% |
| Fenofibric acid DR 45 mg capsule | Generic | $0.161 per capsule | $4.83 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fenofibric acid been recalled?
The FDA's Enforcement Report lists 4 recalls naming fenofibric acid since 2013: 0 Class I (the most serious), 0 Class II, 4 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 1, 2015 | Class III | Tribute Pharmaceuticals US Inc. | Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the … |
| February 27, 2013 | Class III | Mutual Pharmaceutical Company, Inc. | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fenofibric acid label say about other medicines?
The fenofibric acid label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name fenofibric acid. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Colchicine | drug interactions | Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibric acid delayed-release capsules outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Cyclosporine | drug interactions | Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including … Intervention: The benefits and risks of using fenofibric acid delayed-release capsules with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage … |
| Fenofibrate | contraindications | Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules. |
| Gemfibrozil | warnings and precautions | Because of chemical, pharmacological, and clinical similarities between fenofibrates, including fenofibric acid delayed-release capsules; pemafibrate; clofibrate; and gemfibrozil; the findings in 5 large randomized, placebo-controlled clinical trials with these other fibrate drugs may also apply to fenofibric acid … |
| Tacrolimus | drug interactions | Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including … Intervention: The benefits and risks of using fenofibric acid delayed-release capsules with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage … |
Other labels that name fenofibric acid
Source: FDA drug label (FENOFIBRIC ACID), Aurobindo Pharma Limited, effective August 2, 2025 (SPL set 9ad201de-fa62-4c49-bc61-ee09b9ba434c), via openFDA; the full label on DailyMed
What do FAERS reports show for fenofibric acid?
The FDA Adverse Event Reporting System holds 776 reports that list fenofibric acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 200 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fenofibric acid?
15 other medicines are given the same way (oral) and in the same FDA class as fenofibric acid or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fenofibrate | High cholesterol, High triglycerides | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Gemfibrozil | High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Atorvastatin | High cholesterol, High triglycerides | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe | High cholesterol | 23 labelers | $0.0667 per tablet 10 mg tablet | No current entry |
| Cholestyramine | High cholesterol | 15 labelers | $0.834 per packet Cholestyramine packet | No current entry |
| Colesevelam | High cholesterol | 15 labelers | $0.262 per tablet 625 mg tablet | No current entry |
Every medicine labeled for the same conditions as fenofibric acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fenofibric acid compare with medicines for the same use?
1 side-by-side page set fenofibric acid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fenofibric acid
- 15 medicines for the same use
- Other peroxisome proliferator receptor alpha agonists
- the pharmacologic class, with prices and generics
- Fenofibric acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other