Iclusig

Product NDC: 76189-535
11-digit product format: 761890535
Labeler code: 76189
Product ID: 76189-535_618b6b2f-ca86-4839-9170-e873e279d592
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ponatinib hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ARIAD Pharmaceuticals, Inc.
Application: NDA203469
Marketing category: NDA
Marketing start: 2012-12-14
Marketing end: 2020-07-26
Substance: PONATINIB HYDROCHLORIDE
Active strength: 15 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76189-535		D	Discontinued by firm	2026-08-11
excluded package	package	76189-535	76189-535-30	D	Discontinued by firm	2026-08-11
excluded package	package	76189-535	76189-535-60	D	Discontinued by firm	2026-08-11
excluded package	package	76189-535	76189-535-80	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76189-535-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76189-535-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76189-535-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76189-535-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76189-535-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76189-535-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76189-535-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76189-535-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76189-535-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76189-535-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76189-535-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76189-535-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76189-535-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76189-535-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76189-535-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76189-535-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76189-535-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76189-535-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76189-535-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76189-535-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76189-535-80	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76189-535-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76189-535-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76189-535-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76189-535-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76189-535-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76189-535-80	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76189-535-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76189-535-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76189-535-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76189-535-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76189-535-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76189-535-80	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76189-535-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76189-535-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76189-535-80	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N203469-001	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14
N203469-002	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	RLD	2012-12-14
N203469-003	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23
N203469-004	ICLUSIG	PONATINIB HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2020-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203469-001	9029533	2026-12-22	U-1283		2015-06-09
N203469-001	9029533	2026-12-22	U-1699		2015-06-09
N203469-001	9029533	2026-12-22	U-1700		2015-06-09
N203469-001	9029533	2026-12-22	U-1701		2015-06-09
N203469-001	9029533	2026-12-22	U-836		2015-06-09
N203469-001	8114874	2027-01-24		Drug substance, Drug product
N203469-001	11192895	2033-12-12	U-1700		2022-01-06
N203469-001	11192895	2033-12-12	U-1701		2022-01-06
N203469-001	11192895	2033-12-12	U-1948		2022-01-06
N203469-001	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-001	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-001	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-001	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-001	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-001	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-001	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-001	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-002	9029533	2026-12-22	U-1283		2015-06-09
N203469-002	9029533	2026-12-22	U-1699		2015-06-09
N203469-002	9029533	2026-12-22	U-1700		2015-06-09
N203469-002	9029533	2026-12-22	U-1701		2015-06-09
N203469-002	9029533	2026-12-22	U-836		2015-06-09
N203469-002	8114874	2027-01-24		Drug substance, Drug product
N203469-002	11192895	2033-12-12	U-1700		2022-01-06
N203469-002	11192895	2033-12-12	U-1701		2022-01-06
N203469-002	11192895	2033-12-12	U-1948		2022-01-06
N203469-002	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-002	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-002	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-002	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-002	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-002	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-002	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-002	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-003	9029533	2026-12-22	U-1283		2015-06-09
N203469-003	9029533	2026-12-22	U-1699		2015-06-09
N203469-003	9029533	2026-12-22	U-1700		2015-06-09
N203469-003	9029533	2026-12-22	U-1701		2015-06-09
N203469-003	9029533	2026-12-22	U-836		2015-06-09
N203469-003	8114874	2027-01-24		Drug substance, Drug product	2015-06-09
N203469-003	11192895	2033-12-12	U-1700		2022-01-06
N203469-003	11192895	2033-12-12	U-1701		2022-01-06
N203469-003	11192895	2033-12-12	U-1948		2022-01-06
N203469-003	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-003	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-003	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-003	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-003	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-003	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-003	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29
N203469-003	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29
N203469-004	9029533	2026-12-22	U-1283		2021-01-14
N203469-004	9029533	2026-12-22	U-1699		2021-01-14
N203469-004	9029533	2026-12-22	U-1700		2021-01-14
N203469-004	9029533	2026-12-22	U-1701		2021-01-14
N203469-004	9029533	2026-12-22	U-836		2021-01-14
N203469-004	8114874	2027-01-24		Drug substance, Drug product	2021-01-14
N203469-004	11192895	2033-12-12	U-1700		2022-01-06
N203469-004	11192895	2033-12-12	U-1701		2022-01-06
N203469-004	11192895	2033-12-12	U-1948		2022-01-06
N203469-004	11192897	2033-12-12	U-1700	Drug substance	2022-01-06
N203469-004	11192897	2033-12-12	U-1701	Drug substance	2022-01-06
N203469-004	11192897	2033-12-12	U-1948	Drug substance	2022-01-06
N203469-004	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03
N203469-004	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03
N203469-004	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03
N203469-004	9493470	2033-12-12	U-1700	Drug substance, Drug product	2021-01-14
N203469-004	9493470	2033-12-12	U-1948	Drug substance, Drug product	2021-01-14

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203469-001	I-934	2027-03-19
N203469-001	ODE-472	2031-03-19
N203469-002	I-934	2027-03-19
N203469-002	ODE-472	2031-03-19
N203469-003	I-934	2027-03-19
N203469-003	ODE-472	2031-03-19
N203469-004	I-934	2027-03-19
N203469-004	ODE-472	2031-03-19

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.

Product history page 1 of 4 · 158 observed 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	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD	2012-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203469-001	ICLUSIG	EQ 15MG BASE	TABLET / ORAL	RLD	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-002	ICLUSIG	EQ 45MG BASE	TABLET / ORAL	RLD, RS	2012-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-003	ICLUSIG	EQ 30MG BASE	TABLET / ORAL	RLD	2015-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203469-004	ICLUSIG	EQ 10MG BASE	TABLET / ORAL	RLD	2020-12-18	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 59 · 2,356 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	N203469-001	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	8114874	2027-01-24		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1700		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1701		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192895	2033-12-12	U-1948		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1700	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1701	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11192897	2033-12-12	U-1948	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	8114874	2027-01-24		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1700		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1701		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192895	2033-12-12	U-1948		2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1700	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1701	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11192897	2033-12-12	U-1948	Drug substance	2022-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1948	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1701	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	11384086	2033-12-12	U-1700	Drug substance, Drug product	2022-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9493470	2033-12-12	U-1948	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	9493470	2033-12-12	U-1700	Drug substance, Drug product	2016-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1701		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-836		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1283		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1700		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	9029533	2026-12-22	U-1699		2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	8114874	2027-01-24		Drug substance, Drug product	2015-06-09	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 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	N203469-001	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-001	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-002	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-003	ODE-472	2031-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	I-934	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203469-004	ODE-472	2031-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-001	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-002	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-003	ODE-472	2031-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	I-934	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203469-004	ODE-472	2031-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203469-001	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-001	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-002	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-003	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	I-934	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203469-004	ODE-472	2031-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-001	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-002	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-003	ODE-472	2031-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	I-934	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203469-004	ODE-472	2031-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-001	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-002	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-003	ODE-472	2031-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	I-934	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203469-004	ODE-472	2031-03-19	`b8a1b40f171c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76189-535-30	EA - Each	76189-535	b438a922-644f-49d7-a7f7-e31124446f2f	1	2014-11-05
76189-535-60	EA - Each	76189-535	e99c1aae-d25f-4a32-8524-efa76c2262f3	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ponatinib hydrochloride	ACTIVE INGREDIENT	96R6PU3D8J	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
ponatinib	ACTIVE MOIETY	4340891KFS	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7
sodium starch glycolate type B potato	INACTIVE INGREDIENT	27NA468985	ICLUSIG (PONATINIB HYDROCHLORIDE) TABLET, FILM COATED [ARIAD PHARMACEUTICALS, INC.]	7

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
Iclusig	PONATINIB HYDROCHLORIDE	Takeda Pharmaceuticals America, Inc.	16d804b6-4957-43ee-b18c-3b36ec37c5ac	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203469 application number: NDA203469

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
96R6PU3D8J	PONATINIB HYDROCHLORIDE	1114544-31-8	PONATINIB HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Iclusig	ARIAD Pharmaceuticals, Inc. \| Ash Stevens Inc. \| Metrics Inc. \| Micron Technologies \| Catalent Pharma Solutions \| Boehringer Ingelheim Roxane, Inc. \| Sharp Corporation \| Haupt Pharma Amareg GmbH \| Patheon	2018-07-30	HUMAN PRESCRIPTION DRUG LABEL	12