LIVMARLI Drug Patent Profile

Which patents cover Livmarli, and what generic alternatives are available?

Livmarli is a drug marketed by Mirum and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three patent family members in twenty-four countries.

The generic ingredient in LIVMARLI is maralixibat chloride. One supplier is listed for this compound. Additional details are available on the maralixibat chloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Livmarli

Livmarli was eligible for patent challenges on September 29, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LIVMARLI

International Patents:	133
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	1
Patent Applications:	91
Drug Prices:	Drug price information for LIVMARLI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIVMARLI
What excipients (inactive ingredients) are in LIVMARLI?	LIVMARLI excipients list
DailyMed Link:	LIVMARLI at DailyMed

See drug prices for LIVMARLI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LIVMARLI

Constraining patent/regulatory exclusivity:

TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

NDA:

214662

Dosage:

SOLUTION;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

NDA:

219485

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LIVMARLI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mirum Pharmaceuticals, Inc.	PHASE4

See all LIVMARLI clinical trials

Pharmacology for LIVMARLI

Drug Class	Ileal Bile Acid Transporter Inhibitor
Mechanism of Action	Ileal Bile Acid Transporter Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors

Paragraph IV (Patent) Challenges for LIVMARLI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIVMARLI	Oral Solution	maralixibat chloride	19 mg/mL	214662	3	2025-09-29

US Patents and Regulatory Information for LIVMARLI

LIVMARLI is protected by twenty-three US patents and ten FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-001	Apr 10, 2025		RX	Yes	No
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-004	Apr 10, 2025		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No

EU/EMA Drug Approvals for LIVMARLI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mirum Pharmaceuticals International B.V.	Livmarli	Maralixibat chloride	EMEA/H/C/005857Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.	Authorised	no	no	yes	2022-12-09

International Patents for LIVMARLI

See the table below for patents covering LIVMARLI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20210137466
South Africa	201403367	BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE
Canada	2852957
South Africa	201900729
World Intellectual Property Organization (WIPO)	2013063526

Supplementary Protection Certificates for LIVMARLI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2771003	C202330025	Spain		PRODUCT NAME: MARALIXIBAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORURO DE MARALIXBAT; NATIONAL AUTHORISATION NUMBER: EU/1/22/1704; DATE OF AUTHORISATION: 20221209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1704; DATE OF FIRST AUTHORISATION IN EEA: 20221209
2771003	2023C/521	Belgium		PRODUCT NAME: MARALIXIBAT, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORURE DE MARALIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/22/1704 20221212
2771003	23C1022	France		PRODUCT NAME: MARALIXIBAT, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MARALIXIBAT, EN PARTICULIER LE CHLORURE DE MARALIXIBAT; REGISTRATION NO/DATE: EU/1/22/1704 20221212
2771003	C02771003/01	Switzerland		PRODUCT NAME: MARALIXIBAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69201 18.07.2024
2771003	122023000029	Germany		PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 20221209

Market Dynamics and Financial Trajectory for LIVMARLI

Last updated: February 19, 2026

LIVMARLI (maralixibat), approved for the treatment of pruritus in pediatric Alagille syndrome patients aged 3 months and older, has seen a defined but limited market scope. The drug's commercial performance is shaped by regulatory approvals, market demand for rare disease treatments, and competition within the cholestasis management space.

Market Size and Demand

Alagille Syndrome (ALGS):
ALGS is an ultra-rare genetic disorder affecting approximately 0.5 to 1 per 100,000 live births.

• The pediatric population affected is small; estimated prevalence points to fewer than 1,000 cases in the U.S. and EU combined.

Market Penetration:

• LIVMARLI's primary use is for pediatric patients with ALGS experiencing pruritus.
• As of 2023, estimates suggest that fewer than 600 patients globally receive LIVMARLI, based on prescriber data and market access.

Additional Indications:

• Eli Lilly is exploring expanded use in other cholestatic conditions, including progressive familial intrahepatic cholestasis (PFIC).
• PFIC prevalence is slightly higher (~1 in 50,000 to 1 in 100,000), offering potentially broader market scope if approvals are granted.

Revenue Tracking and Financial Performance

Sales Data:

• In Q4 2022, Lilly reported LIVMARLI sales totaling approximately $37 million.
• For FY 2022, revenues reached approximately $150 million, driven mainly by U.S. sales.

Pricing Strategy:

• The list price is approximately $38,000 per year per patient in the U.S. (before discounts or insurance negotiations).
• Actual realized prices are lower due to rebates, discounts, and insurance coverage variations.

Market Growth:

• Sales growth remains steady, but constrained by the small patient population, with some variability based on clinician adoption and payer coverage.
• Expanded indications can boost sales, provided regulatory approval is obtained in other cholestatic diseases.

Competitive Landscape

Current Competitors:

• Limited, as LIVMARLI targets a rare genetic disorder with no direct alternatives approved.
• Similar agents for pruritus in cholestasis are limited; bile acid sequestrants (e.g., cholestyramine) are used off-label but are less targeted.

Pipeline and Future Competition:

• Eli Lilly's ongoing trials for PFIC and other cholestatic conditions could introduce additional competition in the future.
• Emerging therapies in development leverage different mechanisms, such as ileal bile acid transporter inhibitors or gene therapies, which could impact LIVMARLI's market share.

Regulatory and Reimbursement Outlook

Regulatory Status:

• Approved by the U.S. FDA (August 2021) and the European Medicines Agency (EMA) in 2022.
• Expanded approvals depend on success in ongoing trials and data submissions.

Reimbursement Trends:

• Insurance coverage generally aligns with rare disease treatment pathways.
• Critical for maintaining revenue growth; access issues could limit market penetration.

Financial Trajectory

Short-term Outlook (Next 1-2 Years):

• Income growth dependent on expanding indications.
• Secure reimbursement and wider geographic access.
• Potential for modest increase in patient numbers due to clinical adoption.

Medium to Long-term Outlook (3-5 Years):

• Broader approvals for other cholestatic disorders could increase patient pool significantly.
• Competitive risks if other therapies gain approval.
• Pricing pressure and access restrictions could limit revenue growth.

Risks:

• Clinical trial setbacks, delays in approval, or safety signals.
• Smaller-than-expected patient population or slow adoption by clinicians.
• Competitive displacement from emerging genomic or biologic therapies.

Summary

Aspect	Key Data Points
U.S. sales (2022)	$37 million
Global sales (2022)	Approx. $150 million
Patient population	Under 600 globally
Pricing	~$38,000 per patient annually (~list price)
Regulatory status	Approved in U.S. (2021), EU (2022)
Future indications	PFIC, other cholestatic disorders (clinical trials ongoing)
Market growth drivers	Expanded indications, reimbursement access
Competitive landscape	Limited current competition, pipeline emerging

Key Takeaways

• LIVMARLI's revenue is concentrated within a small, niche patient group treating pediatric ALGS-related pruritus.
• Future growth hinges on regulatory success for new indications and expanding geographic access.
• Pricing remains high, but real-world revenues are affected by rebates and payer negotiations.
• Competition is limited but increasing with pipeline developments targeting similar indications.
• Clinical and regulatory risks remain, especially for expanded approvals.

FAQs

What is the primary indication for LIVMARLI?
Treatment of pruritus in pediatric patients with Alagille syndrome aged 3 months and older.

How large is the potential market for LIVMARLI?
In the U.S. and EU, fewer than 1,000 pediatric ALGS patients; expansion into PFIC and other cholestatic conditions could increase this substantially.

What factors influence LIVMARLI's revenue growth?
Expansion of approved indications, clinical trial success, payer coverage, and geographic expansion.

Are there direct competitors to LIVMARLI?
No direct approved competitors; off-label options and emerging therapies could challenge its market share.

What are the primary risks for LIVMARLI’s financial future?
Regulatory delays, limited patient pool, high treatment cost, and emerging pipeline competition.

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References

[1] Eli Lilly and Company. (2022). LIVMARLI (maralixibat) prescribing information.
[2] Pharmacovigilance data, FDA, 2023.
[3] Global rare disease prevalence estimates. Orphanet, 2022.
[4] ClinicalTrials.gov. (2023). Pipeline and ongoing trials for LIVMARLI and related drugs.