Prescription medicine
Elafibranor Brand names: Iqirvo
Elafibranor (Iqirvo) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the elafibranor FDA label on DailyMed (effective August 11, 2026, Ipsen Biopharmaceuticals, Inc.); the NDA 218860 record on Drugs@FDA; every elafibranor label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Forms and strengths
- 80 mg
Film-coated tablet.
On the market
- Earliest approval on file
- June 10, 2024 Iqirvo, Ipsen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 5, 2044 Iqirvo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 744 through July 30, 2026
What is elafibranor used for?
From the label: indications and usageIQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP) [see Clinical Studies (14) ]. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). […]
FDA pharmacologic class: Peroxisome Proliferator-activated Receptor Agonist.
Source: FDA drug label (IQIRVO), Ipsen Biopharmaceuticals, Inc., effective August 11, 2026 (SPL set d78aa14f-6ec1-4b1d-a4ae-e48658137a25), via openFDA; the full label on DailyMed
Is there a generic for elafibranor (Iqirvo)?
No generic elafibranor is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Iqirvo tablets, the last expiring on March 5, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the elafibranor label say about other medicines?
The elafibranor label names 7 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Fenofibrate | drug interactions | Clinical impact; Co-administration of IQIRVO with other PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid) may increase risk of liver injury and muscle injury. |
| Fenofibric acid | drug interactions | Clinical impact; Co-administration of IQIRVO with other PPAR-alpha agonists (e.g., fenofibrate, fenofibric acid) may increase risk of liver injury and muscle injury. |
| Gemfibrozil | drug interactions | Monitor for signs and symptoms of muscle injury. ( 5.1 , 7.1 ) Strong CYP2C8 Inhibitors: Avoid concomitant use with strong CYP2C8 inhibitors (e.g. gemfibrozil). |
| Levonorgestrel | drug interactions | … ethinylestradiol which may lead to contraceptive failure and/or an increase in breakthrough bleeding, while levonorgestrel exposure remained unaffected. |
| Norgestrel | drug interactions | Intervention; Switch to progestin only product containing levonorgestrel/norgestrel, intrauterine system, or effective non-hormonal contraceptives when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose [see,, ]. |
| Pioglitazone | drug interactions | Clinical impact; Co-administration of IQIRVO with PPAR-gamma agonists (e.g., pioglitazone, rosiglitazone) may increase risk of liver injury. |
| Rifampin | drug interactions | Monitor for signs and symptoms of liver injury (7.2) Rifampin: Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during IQIRVO treatment. |
Source: FDA drug label (IQIRVO), Ipsen Biopharmaceuticals, Inc., effective August 11, 2026 (SPL set d78aa14f-6ec1-4b1d-a4ae-e48658137a25), via openFDA; the full label on DailyMed
What do FAERS reports show for elafibranor?
The FDA Adverse Event Reporting System holds 744 reports that list elafibranor among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 51 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 next?
- Elafibranor side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other