Application 219485

Type: NDA
Sponsor: MIRUM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIVMARLI	MARALIXIBAT CHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	LIVMARLI	MARALIXIBAT CHLORIDE	TABLET;ORAL	EQ 15MG BASE	Yes	No
003	LIVMARLI	MARALIXIBAT CHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	No
004	LIVMARLI	MARALIXIBAT CHLORIDE	TABLET;ORAL	EQ 30MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219485-001	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10
N219485-002	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10
N219485-003	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10
N219485-004	LIVMARLI	MARALIXIBAT CHLORIDE	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219485-001	11260053	2031-05-26	U-4187		2025-08-08
N219485-001	10512657	2032-10-26	U-4186		2025-08-08
N219485-001	11229661	2032-10-26	U-4186		2025-08-08
N219485-001	11376251	2032-10-26	U-4187		2025-08-08
N219485-001	12350267	2032-10-26	U-3973		2025-08-04
N219485-001	11229647	2040-02-12	U-4187		2025-08-08
N219485-001	11497745	2040-02-12	U-4187		2025-08-08
N219485-001	12296050	2043-10-05	U-4186	Drug product	2025-05-29
N219485-001	12296050	2043-10-05	U-4187	Drug product	2025-05-29
N219485-002	11260053	2031-05-26	U-4187		2025-08-08
N219485-002	10512657	2032-10-26	U-4186		2025-08-08
N219485-002	11229661	2032-10-26	U-4186		2025-08-08
N219485-002	11376251	2032-10-26	U-4187		2025-08-08
N219485-002	12350267	2032-10-26	U-3973		2025-08-04
N219485-002	11229647	2040-02-12	U-4187		2025-08-08
N219485-002	11497745	2040-02-12	U-4187		2025-08-08
N219485-002	12296050	2043-10-05	U-4186	Drug product	2025-05-29
N219485-002	12296050	2043-10-05	U-4187	Drug product	2025-05-29
N219485-003	11260053	2031-05-26	U-4187		2025-08-08
N219485-003	10512657	2032-10-26	U-4186		2025-08-08
N219485-003	11229661	2032-10-26	U-4186		2025-08-08
N219485-003	11376251	2032-10-26	U-4187		2025-08-08
N219485-003	12350267	2032-10-26	U-3973		2025-08-04
N219485-003	11229647	2040-02-12	U-4187		2025-08-08
N219485-003	11497745	2040-02-12	U-4187		2025-08-08
N219485-003	12296050	2043-10-05	U-4186	Drug product	2025-05-29
N219485-003	12296050	2043-10-05	U-4187	Drug product	2025-05-29
N219485-004	11260053	2031-05-26	U-4187		2025-08-08
N219485-004	10512657	2032-10-26	U-4186		2025-08-08
N219485-004	11229661	2032-10-26	U-4186		2025-08-08
N219485-004	11376251	2032-10-26	U-4187		2025-08-08
N219485-004	12350267	2032-10-26	U-3973		2025-08-04
N219485-004	11229647	2040-02-12	U-4187		2025-08-08
N219485-004	11497745	2040-02-12	U-4187		2025-08-08
N219485-004	12296050	2043-10-05	U-4186	Drug product	2025-05-29
N219485-004	12296050	2043-10-05	U-4187	Drug product	2025-05-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219485-001	NCE	2026-09-29
N219485-001	I-938	2027-03-13
N219485-002	NCE	2026-09-29
N219485-002	I-938	2027-03-13
N219485-003	NCE	2026-09-29
N219485-003	I-938	2027-03-13
N219485-004	NCE	2026-09-29
N219485-004	I-938	2027-03-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N219485-001	11260053	2031-05-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	10512657	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	11229661	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	11376251	2032-10-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	12350267	2032-10-26	U-3973		2025-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	11229647	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	11497745	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	11260053	2031-05-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	10512657	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	11229661	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	11376251	2032-10-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	12350267	2032-10-26	U-3973		2025-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	11229647	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	11497745	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	11260053	2031-05-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	10512657	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	11229661	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	11376251	2032-10-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	12350267	2032-10-26	U-3973		2025-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	11229647	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	11497745	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	11260053	2031-05-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	10512657	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	11229661	2032-10-26	U-4186		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	11376251	2032-10-26	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	12350267	2032-10-26	U-3973		2025-08-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	11229647	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	11497745	2040-02-12	U-4187		2025-08-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N219485-001	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-001	I-938	2027-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-002	I-938	2027-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-003	I-938	2027-03-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	NCE	2026-09-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219485-004	I-938	2027-03-13	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Livmarli	MARALIXIBAT CHLORIDE	Mirum Pharmaceuticals Inc.	64000394-1ef6-4e76-8ba8-11f25ba1b167	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219485 application number: NDA219485

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84887	ORIG	2026-01-30
81979	ORIG	2025-04-24
81948	ORIG	2025-04-21