Viewing data from:

ICLUSIG

NDA

PONATINIB HYDROCHLORIDE | N203469 | TAKEDA PHARMACEUTICALS USA INC

4 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (2)Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Jan. 24, 2027

Dec. 22, 2026

Dec. 12, 2033

Dec. 12, 2033

Dec. 12, 2033

Dec. 12, 2033

I-934

Mar. 19, 2027

ODE-472

Mar. 19, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
TAKEDA PHARMACEUTICALS U.S.A., INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD. 2:2026cv08064 4 patentsANDA 218126ponatinib	D.N.J.	2026-07-01	Active	—
TAKEDA PHARMACEUTICALS AMERICA, INC. et al v. APOTEX, INC. 2:2021cv12998 3 patentsANDA 215893ponatinib hydrochloride	D.N.J.	2021-06-25	Terminated 2023-02-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia NCT03739814	Phase 2	Recruiting	National Cancer Institute (NCI)	84	2019-05-08 → 2027-02-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Iclusig (2023)

Total Spending

$123.3M

Total Claims

5,760

Beneficiaries

841

Avg Cost/Unit

$686.96

Spending Trend

$78.4M(2019)→$83.0M(2020)→$89.0M(2021)→$100.8M(2022)→$123.3M(2023)

YoY Change:+6.1%

5yr CAGR:+4.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDPONATINIB HYDROCHLORIDE

DMF 323402018

ZHEJIANG LEPU PHARMACEUTICAL CO LTDPONATINIB HYDROCHLORIDE

DMF 354132020

MSN LABORATORIES PRIVATE LTDPONATINIB HYDROCHLORIDE

DMF 378542022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Oct 15, 2025	SUPPL -38	View Letter (PDF)
Mar 20, 2024	SUPPL -37	View Letter (PDF)
Feb 16, 2022	SUPPL -35	View Letter (PDF)
Dec 22, 2020	SUPPL -34	View Letter (PDF)
Jul 13, 2020	SUPPL -33	View Letter (PDF)
Jun 19, 2020	SUPPL -32	View Letter (PDF)
Jan 14, 2020	SUPPL -31	View Letter (PDF)
Oct 23, 2018	SUPPL -30	View Letter (PDF)
May 31, 2018	SUPPL -29	View Letter (PDF)
Dec 27, 2017	SUPPL -27	View Letter (PDF)
Dec 27, 2017	SUPPL -28	View Letter (PDF)
Nov 30, 2016	SUPPL -22	View Letter (PDF)
Sep 8, 2016	SUPPL -24	View Letter (PDF)
Aug 31, 2016	SUPPL -23	View Letter (PDF)
Jun 6, 2016	SUPPL -21	View Letter (PDF)
Dec 3, 2015	SUPPL -20	View Letter (PDF)
Jul 28, 2014	SUPPL -9	View Letter (PDF)
Dec 20, 2013	SUPPL -8	View Letter (PDF)
Dec 20, 2013	SUPPL -7	View Letter (PDF)
Dec 19, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 15MG BASE

RLD

6 patents2 exclusivities▴

TABLET;ORAL | Approved: Dec 14, 2012

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8114874	Jan 24, 2027	—	Yes	Yes	—	—
9029533	Dec 22, 2026	—	—	—		—
9493470	Dec 12, 2033	—	Yes	Yes		—
11192895	Dec 12, 2033	—	—	—		—
11192897	Dec 12, 2033	—	Yes	—		—
11384086	Dec 12, 2033	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
I-934	Mar 19, 2027	< 1 year
ODE-472	Mar 19, 2031	Active

#002 — EQ 45MG BASE

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Dec 14, 2012

#003 — EQ 30MG BASE

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Apr 23, 2015

#004 — EQ 10MG BASE

RLD

6 patents2 exclusivities▾

TABLET;ORAL | Approved: Dec 18, 2020