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 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^: ⤷ Sign Up* 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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-002	Jul 24, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Mexico	369466	INHIBIDORES DE LA RECIRCULACIÓN DE ÁCIDOS BILIARES PARA EL TRATAMIENTO DE ENFERMEDADES HEPÁTICAS COLESTÁSICAS PEDIÁTRICAS. (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES.)	⤷ Sign Up
Portugal	2771003		⤷ Sign Up
South Korea	20210131431	고담혈증 및 담즙 정체성 간 질환 치료용 담즙산 재순환 억제제 (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE)	⤷ Sign Up
Brazil	112021015809	Resposta dependente de genótipo e dose a um asbti em pacientes com deficiência de bomba de exportação de sal biliar	⤷ Sign Up
European Patent Office	4241840	PROCÉDÉS DE TRAITEMENT DE LA CHOLESTASE (METHODS FOR TREATING CHOLESTASIS)	⤷ Sign Up
European Patent Office	3266457	INHIBITEURS DU RECYCLAGE DE L'ACIDE BILIAIRE POUR LE TRAITEMENT DE MALADIES CHOLESTATIQUES HÉPATIQUES PÉDIATRIQUES (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES)	⤷ Sign Up
Eurasian Patent Organization	201792541	ИНГИБИТОРЫ РЕЦИРКУЛЯЦИИ ЖЕЛЧНЫХ КИСЛОТ ДЛЯ ЛЕЧЕНИЯ ГИПЕРХОЛЕМИИ И ХОЛЕСТАТИЧЕСКОГО ЗАБОЛЕВАНИЯ ПЕЧЕНИ	⤷ Sign Up
>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	122023000029	Germany	⤷ Sign Up	PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 20221209
2771003	23C1022	France	⤷ Sign Up	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	CR 2023 00017	Denmark	⤷ Sign Up	PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	301234	Netherlands	⤷ Sign Up	PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212
2771003	CA 2023 00017	Denmark	⤷ Sign Up	PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212
2771003	2023C/521	Belgium	⤷ Sign Up	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	2390017-8	Sweden	⤷ Sign Up	PRODUCT NAME: MARALIXIBAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MARALIXIBAT CHLORIDE; REG. NO/DATE: EU/1/22/1704 20221212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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