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Livmarli

maralixibat chloride · Solution

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Livmarli
Generic name
maralixibat chloride
Dosage form
Solution
Route
Oral
Marketing category
NDA · NDA
Labeler
Mirum Pharmaceuticals Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Maralixibat Chloride 19 mg/mL 2571079 View
Maralixibat Chloride 9.5 mg/mL 2571079 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Ileal Bile Acid Transporter Inhibitor [EPC] EPC 4 members — no class page
Ileal Bile Acid Transporter Inhibitors [MoA] MoA 4 members — no class page
Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214662
Application type
NDA · New Drug Application
Approval date
September 29, 2021
Sponsor
MIRUM
Products on application
2
Submissions recorded
8
Products approved under application 214662.
Product Trade name Form Strength Ingredient Status TE Flags
214662-001 LIVMARLI SOLUTION MARALIXIBAT CHLORIDE Prescription — RLD RS
214662-002 LIVMARLI SOLUTION MARALIXIBAT CHLORIDE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
11260053 May 26, 2031 001 No U-3974 March 1, 2022
11260053 May 26, 2031 001 No U-3290 March 1, 2022
10512657 October 26, 2032 001 No U-3850 March 22, 2024
11229661 October 26, 2032 001 No U-3850 March 22, 2024
11376251 October 26, 2032 001 No U-3290 July 19, 2022
11376251 October 26, 2032 001 No U-3974 July 19, 2022
12350267 October 26, 2032 002 No U-3973 August 5, 2025
11229661 October 26, 2032 002 No U-3973 August 23, 2024
10512657 October 26, 2032 002 No U-3973 August 23, 2024
11918578 February 12, 2040 001 No U-3290 March 22, 2024
11229647 February 12, 2040 001 No U-3974 February 1, 2022
11918578 February 12, 2040 001 No U-3974 March 22, 2024
11497745 February 12, 2040 001 No U-3974 November 30, 2022
11229647 February 12, 2040 001 No U-3290 February 1, 2022
11497745 February 12, 2040 001 No U-3290 November 30, 2022
12599602 February 12, 2040 001 No U-3974 April 22, 2026
12599602 February 12, 2040 001 No U-3290 April 22, 2026
Regulatory exclusivity periods.
Code Expires Product
NPP March 13, 2026 001
NCE September 29, 2026 001
NCE September 29, 2026 002
I-938 March 13, 2027 001
ODE-379 September 29, 2028 001
ODE* September 29, 2028 002
ODE-429 March 13, 2030 001
ODE* March 13, 2030 002
ODE-471 March 13, 2031 001
ODE* March 13, 2031 002
ODE-490 July 24, 2031 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 214662.
Type No. Action Status Date Review
Supplement 11 Labeling Approved November 8, 2024 Standard
Supplement 10 Efficacy Approved July 24, 2024 Standard
Supplement 9 Manufacturing (CMC) Approved July 24, 2024 N/A
Supplement 8 Labeling Approved March 13, 2024 Standard
Supplement 5 Efficacy Approved March 13, 2024 Standard
Supplement 4 Efficacy Approved March 13, 2023 Priority
Supplement 1 Labeling Approved April 1, 2022 Standard
Original application 1 Type 1 - New Molecular Entity Approved September 29, 2021 Priority

Review documents

  • 0 · Supplement · April 15, 2026
  • 0 · Supplement · April 15, 2026
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · November 12, 2024
  • 0 · Supplement · July 25, 2024
  • 0 · Supplement · July 25, 2024
  • 0 · Supplement · March 14, 2024
  • 0 · Supplement · March 14, 2024
  • 0 · Supplement · March 14, 2024
  • 0 · Supplement · March 14, 2024
  • 0 · Supplement · March 14, 2023
  • 0 · Supplement · March 14, 2023
  • 0 · Supplement · April 5, 2022
  • 0 · Supplement · April 4, 2022
  • 0 · Original application · December 10, 2021
  • 0 · Original application · October 21, 2021
  • 0 · Original application · September 29, 2021

Adverse event reports

Source: openFDA FAERS
950
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MARALIXIBAT CHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
79378-110-01 79378-110 Mirum Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (79378-110-01) / 30 mL in 1 BOTTLE September 29, 2021
79378-111-01 79378-111 Mirum Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLE July 24, 2024
79378-110 79378-110 Mirum Pharmaceuticals Inc. — September 29, 2021
79378-111 79378-111 Mirum Pharmaceuticals Inc. — July 24, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.