Details for Patent: 11,376,251

Which drugs does patent 11,376,251 protect, and when does it expire?

Patent 11,376,251 protects LIVMARLI and is included in two NDAs.

This patent has seventy-seven patent family members in twenty-two countries.

Summary for Patent: 11,376,251

Title:	Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Abstract:	Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Inventor(s):	Bronislava Gedulin, Michael Grey, Niall O'Donnell
Assignee:	Shire Human Genetics Therapies Inc
Application Number:	US17/498,586
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,376,251
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 11,376,251

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662-001	Sep 29, 2021		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-001	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-002	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-003	Apr 10, 2025		RX	Yes	No						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485-004	Apr 10, 2025		RX	Yes	Yes						TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE

International Family Members for US Patent 11,376,251

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2771003		2023C/521	Belgium
European Patent Office	2771003		301234	Netherlands
European Patent Office	2771003		CA 2023 00017	Denmark
European Patent Office	2771003		122023000029	Germany
European Patent Office	2771003		21/2023	Austria
European Patent Office	2771003		CR 2023 00017	Denmark