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 42.

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
2026-08-18 06:07:40	2026-07	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-001	LIVMARLI	EQ 10MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-002	LIVMARLI	EQ 15MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-003	LIVMARLI	EQ 20MG BASE	TABLET / ORAL	RLD	2025-04-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-004	LIVMARLI	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-04-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219485-001	11260053	2031-05-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	10512657	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	11229661	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	11376251	2032-10-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	12350267	2032-10-26	U-3973		2025-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	11229647	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	11497745	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	11260053	2031-05-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	10512657	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	11229661	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	11376251	2032-10-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	12350267	2032-10-26	U-3973		2025-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	11229647	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	11497745	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	11260053	2031-05-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	10512657	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	11229661	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	11376251	2032-10-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	12350267	2032-10-26	U-3973		2025-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	11229647	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	11497745	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	11260053	2031-05-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	10512657	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	11229661	2032-10-26	U-4186		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	11376251	2032-10-26	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	12350267	2032-10-26	U-3973		2025-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	11229647	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	11497745	2040-02-12	U-4187		2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	12296050	2043-10-05	U-4187	Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	12296050	2043-10-05	U-4186	Drug product	2025-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219485-001	11260053	2031-05-26	U-4187		2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-001	10512657	2032-10-26	U-4186		2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-001	11229661	2032-10-26	U-4186		2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-001	11376251	2032-10-26	U-4187		2025-08-08	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N219485-001	NCE	2026-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-001	I-938	2027-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	NCE	2026-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-002	I-938	2027-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	NCE	2026-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-003	I-938	2027-03-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	NCE	2026-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219485-004	I-938	2027-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219485-001	NCE	2026-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-001	I-938	2027-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-002	NCE	2026-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-002	I-938	2027-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-003	NCE	2026-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-003	I-938	2027-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-004	NCE	2026-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219485-004	I-938	2027-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-001	NCE	2026-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-001	I-938	2027-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-002	NCE	2026-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-002	I-938	2027-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-003	NCE	2026-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-003	I-938	2027-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-004	NCE	2026-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219485-004	I-938	2027-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219485-001	NCE	2026-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-001	I-938	2027-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-002	NCE	2026-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-002	I-938	2027-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-003	NCE	2026-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-003	I-938	2027-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-004	NCE	2026-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219485-004	I-938	2027-03-13	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-001	NCE	2026-09-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-001	I-938	2027-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-002	NCE	2026-09-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-002	I-938	2027-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-003	NCE	2026-09-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-003	I-938	2027-03-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-004	NCE	2026-09-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219485-004	I-938	2027-03-13	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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