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Last Updated: April 26, 2024

Maralixibat chloride - Generic Drug Details

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What are the generic sources for maralixibat chloride and what is the scope of patent protection?

Maralixibat chloride is the generic ingredient in one branded drug marketed by Mirum and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Maralixibat chloride has one hundred and thirteen patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for maralixibat chloride

International Patents:	113
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	2
Patent Applications:	47
What excipients (inactive ingredients) are in maralixibat chloride?	maralixibat chloride excipients list
DailyMed Link:	maralixibat chloride at DailyMed

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

Generic Entry Date for maralixibat chloride^: ⤷ Try a Trial* 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) 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.

Recent Clinical Trials for maralixibat chloride

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

Sponsor	Phase
Takeda	Phase 3

See all maralixibat chloride clinical trials

Pharmacology for maralixibat chloride

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 maralixibat chloride

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 maralixibat chloride

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for maralixibat chloride

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for maralixibat chloride

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Country	Patent Number	Title	Estimated Expiration
Brazil	112014010228	inibidores de reciclagem de ácidos biliares para tratamento da doença de fígado e hipercolemia colestática	⤷ Try a Trial
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	⤷ Try a Trial
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)	⤷ Try a Trial
Singapore	11201401849Q	BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for maralixibat chloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2771003	2023C/521	Belgium	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	21/2023	Austria	⤷ Try a Trial	PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212
2771003	301234	Netherlands	⤷ Try a Trial	PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.