Application 218276

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FABHALTA	IPTACOPAN HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218276-001	FABHALTA	IPTACOPAN HYDROCHLORIDE	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2023-12-05

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218276-001	10093663	2034-07-14	U-3980		2024-09-04
N218276-001	10093663	2034-07-14	U-4161		2024-09-04
N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18
N218276-001	11723901	2038-08-30	U-3980		2024-09-04
N218276-001	12285422	2038-08-30	U-4181		2025-05-19
N218276-001	12384758	2041-05-17	U-3980		2025-08-20
N218276-001	12384758	2041-05-17	U-4161		2025-08-20
N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18
N218276-001	11951101	2041-07-15	U-3895		2024-05-07
N218276-001	12453726	2041-07-15	U-4300		2025-11-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218276-001	I-949	2027-08-07
N218276-001	I-963	2028-03-20
N218276-001	NCE	2028-12-05
N218276-001	ODE-456	2030-12-05
N218276-001	ODE-524	2032-03-20

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
2026-02-19 14:30 UTC	2026-02	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218276-001	FABHALTA	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2023-12-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218276-001	10093663	2034-07-14	U-4161		2024-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	12285422	2038-08-30	U-4181		2025-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	12384758	2041-05-17	U-3980		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	12384758	2041-05-17	U-4161		2025-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	11951101	2041-07-15	U-3895		2024-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	12453726	2041-07-15	U-4300		2025-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	10093663	2034-07-14	U-4161		2024-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	12285422	2038-08-30	U-4181		2025-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	12384758	2041-05-17	U-3980		2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	12384758	2041-05-17	U-4161		2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	11951101	2041-07-15	U-3895		2024-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	12453726	2041-07-15	U-4300		2025-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218276-001	10093663	2034-07-14	U-4161		2024-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	12285422	2038-08-30	U-4181		2025-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	11951101	2041-07-15	U-3895		2024-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	11951101	2041-07-15	U-3895		2024-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	11603363	2041-05-25		Drug substance, Drug product	2023-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	11951101	2041-07-15	U-3895		2024-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	10093663	2034-07-14	U-3980		2024-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	9682968	2034-07-14		Drug substance, Drug product	2023-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	11723901	2038-08-30	U-3980		2024-09-04	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218276-001	I-949	2027-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	I-963	2028-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	NCE	2028-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218276-001	ODE-456	2030-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	I-949	2027-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	I-963	2028-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	NCE	2028-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218276-001	ODE-456	2030-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218276-001	I-949	2027-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	I-963	2028-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	NCE	2028-12-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218276-001	ODE-456	2030-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	I-949	2027-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	NCE	2028-12-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218276-001	ODE-456	2030-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	I-949	2027-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	NCE	2028-12-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218276-001	ODE-456	2030-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	I-949	2027-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	NCE	2028-12-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218276-001	ODE-456	2030-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218276-001	I-949	2027-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218276-001	NCE	2028-12-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218276-001	ODE-456	2030-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218276-001	I-949	2027-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218276-001	NCE	2028-12-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218276-001	ODE-456	2030-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218276-001	I-949	2027-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218276-001	NCE	2028-12-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218276-001	ODE-456	2030-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218276-001	I-949	2027-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218276-001	NCE	2028-12-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218276-001	ODE-456	2030-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218276-001	NCE	2028-12-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218276-001	ODE-456	2030-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218276-001	NCE	2028-12-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218276-001	ODE-456	2030-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218276-001	NCE	2028-12-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218276-001	ODE-456	2030-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218276-001	NCE	2028-12-05	`8072bd15b7f6…`

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
FABHALTA	IPTACOPAN	Novartis Pharmaceuticals Corporation	a76b5845-6e21-4d3b-ad07-cd8df1b60bee	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218276 application number: NDA218276

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81681	SUPPL	2025-03-24
81662	SUPPL	2025-03-20
81661	SUPPL	2025-03-20
79352	SUPPL	2024-08-09
79326	SUPPL	2024-08-07
78565	SUPPL	2024-05-28
77999	SUPPL	2024-03-27
77981	SUPPL	2024-03-27
77151	ORIG	2023-12-27
76744	ORIG	2023-12-06
76739	ORIG	2023-12-06