Application 218860

Type: NDA
Sponsor: IPSEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IQIRVO	ELAFIBRANOR	TABLET;ORAL	80MG	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
N218860-001	IQIRVO	ELAFIBRANOR	80MG	TABLET / ORAL		RLD, RS	2024-06-10

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N218860-001	11185519	2037-03-30	U-3955	2024-06-25
N218860-001	11331292	2037-03-30	U-1854	2024-06-25
N218860-001	11850223	2037-03-30	U-1854	2024-06-25
N218860-001	11857523	2037-03-30	U-3955	2024-06-25
N218860-001	12233038	2037-03-30	U-1854	2025-03-12
N218860-001	12295927	2037-03-30	U-1854	2025-06-03
N218860-001	12295928	2037-03-30	U-1854	2025-06-03
N218860-001	12310935	2037-03-30	U-1854	2025-06-03
N218860-001	12589086	2037-03-30	U-4473	2026-04-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218860-001	NCE	2029-06-10
N218860-001	ODE-486	2031-06-10

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	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218860-001	IQIRVO	80MG	TABLET / ORAL	RLD, RS	2024-06-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 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	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	12233038	2037-03-30	U-1854		2025-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	12295927	2037-03-30	U-1854		2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	12295928	2037-03-30	U-1854		2025-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	12310935	2037-03-30	U-1854		2025-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	12233038	2037-03-30	U-1854		2025-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	12295927	2037-03-30	U-1854		2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	12295928	2037-03-30	U-1854		2025-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	12310935	2037-03-30	U-1854		2025-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	12233038	2037-03-30	U-1854		2025-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	12295927	2037-03-30	U-1854		2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	12295928	2037-03-30	U-1854		2025-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	12310935	2037-03-30	U-1854		2025-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	12233038	2037-03-30	U-1854		2025-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	7632870	2024-09-09		Drug product	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	7943661	2024-09-09		Drug substance, Drug product	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	11185519	2037-03-30	U-3955		2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	11331292	2037-03-30	U-1854		2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	11850223	2037-03-30	U-1854		2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	11857523	2037-03-30	U-3955		2024-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218860-001	7632870	2024-09-09		Drug product	2024-06-25	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N218860-001	NCE	2029-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218860-001	ODE-486	2031-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	NCE	2029-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218860-001	ODE-486	2031-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218860-001	NCE	2029-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218860-001	ODE-486	2031-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	NCE	2029-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218860-001	ODE-486	2031-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	NCE	2029-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218860-001	ODE-486	2031-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	NCE	2029-06-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218860-001	ODE-486	2031-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218860-001	NCE	2029-06-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218860-001	ODE-486	2031-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218860-001	NCE	2029-06-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218860-001	ODE-486	2031-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218860-001	NCE	2029-06-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218860-001	ODE-486	2031-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218860-001	NCE	2029-06-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218860-001	ODE-486	2031-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218860-001	NCE	2029-06-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218860-001	ODE-486	2031-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218860-001	NCE	2029-06-10	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218860-001	NCE	2029-06-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218860-001	ODE-486	2031-06-10	`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
IQIRVO	ELAFIBRANOR	Ipsen Biopharmaceuticals, Inc.	d78aa14f-6ec1-4b1d-a4ae-e48658137a25	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218860 application number: NDA218860

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79194	ORIG	2024-07-24
78766	ORIG	2024-06-11
78761	ORIG	2024-06-11