Prescription medicine
Maralixibat Brand names: Livmarli
Maralixibat (Livmarli) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the maralixibat FDA label on DailyMed (effective April 10, 2025, Mirum Pharmaceuticals Inc.); the NDA 214662 record on Drugs@FDA; every maralixibat label on DailyMed.
Highlights of the record
FDA label of April 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for:
the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS).
Forms and strengths
- 10 mg
- 15 mg
- 20 mg
- 30 mg
- 9.5 mg/ml
- 19 mg/ml
Tablet; solution.
On the market
- Earliest approval on file
- September 29, 2021 Livmarli, Mirum; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- October 5, 2043 Livmarli 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
- 950 through July 30, 2026
What is maralixibat used for?
From the label: indications and usageLIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for:
the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). ( 1.1 )
the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.2 ) o Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein. […]
FDA pharmacologic class: Ileal Bile Acid Transporter Inhibitor.
Source: FDA drug label (Livmarli), Mirum Pharmaceuticals Inc., effective April 10, 2025 (SPL set 64000394-1ef6-4e76-8ba8-11f25ba1b167), via openFDA; the full label on DailyMed
Is there a generic for maralixibat (Livmarli)?
No generic maralixibat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Livmarli tablets, the last expiring on October 5, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the maralixibat label say about other medicines?
The maralixibat label names 3 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 |
|---|---|---|
| Cholestyramine | drug interactions | Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol). |
| Colesevelam | drug interactions | Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol). |
| Colestipol | drug interactions | Administer LIVMARLI at least 4 hours before or 4 hours after administration of bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol). |
Source: FDA drug label (Livmarli), Mirum Pharmaceuticals Inc., effective April 10, 2025 (SPL set 64000394-1ef6-4e76-8ba8-11f25ba1b167), via openFDA; the full label on DailyMed
What do FAERS reports show for maralixibat?
The FDA Adverse Event Reporting System holds 950 reports that list maralixibat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 132 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?
- Other ileal bile acid transporter inhibitors
- the pharmacologic class, with prices and generics
- Maralixibat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other