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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 one NDA. There are four patents protecting this drug.

This drug has one hundred and thirteen patent family members in twenty-one 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 will be eligible for patent challenges on September 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LIVMARLI

International Patents:	113
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Patent Applications:	51
Drug Prices:	Drug price information 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 PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS)

NDA:

214662

Dosage:

SOLUTION;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.

Pharmacology for LIVMARLI

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

Anatomical Therapeutic Chemical (ATC) Classes for LIVMARLI

A05AX	Other drugs for bile therapy
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

US Patents and Regulatory Information for LIVMARLI

LIVMARLI is protected by four US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS).

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

Patents protecting LIVMARLI

FDA Regulatory Exclusivity protecting LIVMARLI

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	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes

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/005857 Livmarli 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
Brazil	112014010228	inibidores de reciclagem de ácidos biliares para tratamento da doença de fígado e hipercolemia colestática
Japan	2022521713	胆汁うっ滞性肝疾患を有する小児対象の成長を増加させる方法
European Patent Office	3278796	INHIBITEURS DU RECYCLAGE DE L'ACIDE BILIAIRE POUR TRAITEMENT DE L'HYPERCHOLÉMIE ET DE LA MALADIE CHOLESTATIQUE HÉPATIQUE (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE)
Singapore	11201401849Q	BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES
Singapore	10201406155Q	Bile Acid Recycling Inhibitors For Treatment Of Pediatric Cholestatic Liver Diseases

Supplementary Protection Certificates for LIVMARLI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2023 00017	Denmark		PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	21/2023	Austria		PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212
2771003	301234	Netherlands		PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212
2771003	2390017-8	Sweden		PRODUCT NAME: MARALIXIBAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MARALIXIBAT CHLORIDE; REG. NO/DATE: EU/1/22/1704 20221212