Application 218709

Type: NDA
Sponsor: X4 PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOLREMDI	MAVORIXAFOR	CAPSULE;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218709-001	XOLREMDI	MAVORIXAFOR	100MG	CAPSULE / ORAL		RLD, RS	2024-04-26

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218709-001	10953003	2036-12-14		Drug product	2024-05-24
N218709-001	10610527	2036-12-22	U-3932		2024-05-24
N218709-001	11219621	2036-12-22	U-3932		2024-05-24
N218709-001	10548889	2038-12-11		Drug product	2024-05-24
N218709-001	11045461	2038-12-11		Drug product	2024-05-24
N218709-001	12115156	2038-12-11		Drug product	2024-10-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218709-001	NCE	2029-04-26
N218709-001	ODE-480	2031-04-26

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
2026-09-14 22:38:34	2026-08	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218709-001	XOLREMDI	100MG	CAPSULE / ORAL	RLD, RS	2024-04-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	11045461	2038-12-11		Drug product	2024-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	12115156	2038-12-11		Drug product	2024-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	10953003	2036-12-14		Drug product	2024-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	10610527	2036-12-22	U-3932		2024-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	11219621	2036-12-22	U-3932		2024-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	10548889	2038-12-11		Drug product	2024-05-24	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218709-001	NCE	2029-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218709-001	ODE-480	2031-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218709-001	NCE	2029-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218709-001	ODE-480	2031-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218709-001	NCE	2029-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218709-001	ODE-480	2031-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	NCE	2029-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218709-001	ODE-480	2031-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218709-001	NCE	2029-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218709-001	ODE-480	2031-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	NCE	2029-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218709-001	ODE-480	2031-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	NCE	2029-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218709-001	ODE-480	2031-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218709-001	NCE	2029-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218709-001	ODE-480	2031-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218709-001	NCE	2029-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218709-001	ODE-480	2031-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218709-001	NCE	2029-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218709-001	ODE-480	2031-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218709-001	NCE	2029-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218709-001	ODE-480	2031-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218709-001	NCE	2029-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218709-001	ODE-480	2031-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218709-001	NCE	2029-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218709-001	ODE-480	2031-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218709-001	NCE	2029-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218709-001	ODE-480	2031-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218709-001	NCE	2029-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218709-001	ODE-480	2031-04-26	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218709-001	NCE	2029-04-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218709-001	ODE-480	2031-04-26	`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
XOLREMDI	MAVORIXAFOR	X4 Pharmaceuticals, Inc.	7f3a5ee3-ca73-4876-85a0-ed1e108a2237	2024-11-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218709 application number: NDA218709

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78566	ORIG	2024-05-28
78301	ORIG	2024-04-29
78285	ORIG	2024-04-29