Maralixibat chloride - Generic Drug Details

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What are the generic drug 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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for maralixibat chloride

International Patents:	114
US Patents:	7
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^: ⤷ Subscribe* 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) 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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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
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	⤷ Subscribe
Australia	2020221834	Genotype and dose-dependent response to an ASBTI in patients with bile salt export pump deficiency	⤷ Subscribe
Australia	2019202884	Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases	⤷ Subscribe
Australia	2017213485	Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases	⤷ Subscribe
Hong Kong	1249045	用於治療高膽血症和膽汁淤積性肝病的膽汁酸再循環抑制劑 (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE)	⤷ Subscribe
Eurasian Patent Organization	201792541	ИНГИБИТОРЫ РЕЦИРКУЛЯЦИИ ЖЕЛЧНЫХ КИСЛОТ ДЛЯ ЛЕЧЕНИЯ ГИПЕРХОЛЕМИИ И ХОЛЕСТАТИЧЕСКОГО ЗАБОЛЕВАНИЯ ПЕЧЕНИ	⤷ Subscribe
>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	C202330025	Spain	⤷ Subscribe	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	23C1022	France	⤷ Subscribe	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	2390017-8	Sweden	⤷ Subscribe	PRODUCT NAME: MARALIXIBAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MARALIXIBAT CHLORIDE; REG. NO/DATE: EU/1/22/1704 20221212
2771003	CR 2023 00017	Denmark	⤷ Subscribe	PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	21/2023	Austria	⤷ Subscribe	PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212
2771003	301234	Netherlands	⤷ Subscribe	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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