DrugPatentWatch Database Preview

ICLUSIG Drug Profile

« Back to Dashboard

When do Iclusig patents expire, and what generic alternatives are available?

Iclusig is a drug marketed by Ariad and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-eight patent family members in twenty-one countries.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Iclusig

Iclusig was eligible for patent challenges on December 14, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ICLUSIG

International Patents:	78
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	92
Clinical Trials:	18
Patent Applications:	80
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ICLUSIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ICLUSIG
DailyMed Link:	ICLUSIG at DailyMed

See drug prices for ICLUSIG

Generic Entry Opportunity Date for ICLUSIG

NDA:

203469

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ICLUSIG

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Millennium Pharmaceuticals, Inc.	Phase 2
Antonio Fojo	Phase 2
Versailles Hospital	Phase 2

See all ICLUSIG clinical trials

Recent Litigation for ICLUSIG

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Ariad Pharmaceuticals, Inc. v. Matal

See all ICLUSIG litigation

Pharmacology for ICLUSIG

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for ICLUSIG

0LI

1114544-31-8

3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide

3-(2-(Imidazo(1,2-b)pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1- yl)methyl)-3-(trifluoromethyl)phenyl)benzamide monohydrochloride

3-(2-(Imidazo[1,2-b]pyridazin-3-yl)ethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide

3-(2-{imidazo[1,2-b]pyridazin-3-yl}ethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide hydrochloride

3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-benzamide

3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]benzamide

3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide

3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide

3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methylpiperazin-1-yl)methyl)-3-(trifluoromethyl)phenyl)benzamide hydrochloride

3-(Imidazo[1,2-B]pyridazin-3-Ylethynyl)-4-Methyl-N-{4-[(4-Methylpiperazin-1-Yl)methyl]-3-(Trifluoromethyl)phenyl}benzamide

3-[2-(imidazo[1,2-b]pyridazin-3-yl)ethynyl]-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide

4340891KFS

943319-70-8

96R6PU3D8J

AB0008178

AB01565847_03

ABP000881

AC-26973

AKOS015995214

AKOS030621539

AM81261

AOB3899

AOB87302

AP 24534

AP 24534 hydrochloride

AP-24534

AP-24534 HCl

AP-24534, Ponatinib, AP24534

AP24534

AP24534 - Ponatinib

AP24534 HCL

AP24534 Hydrochloride

AP24534,Ponatinib

AP24534(Ponatinib)

AS-16772

AS-19133

BC659935

BCP02037

BCP10906

BCP9000307

BCPP000397

BDBM50322535

Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-

Benzamide, 3-(2-imidazo(1,2-b)pyridazin-3-ylethynyl)-4-methyl-N-(4-((4-methyl-1- piperazinyl)methyl)-3-(trifluoromethyl)phenyl)-, hydrochloride (1:1)

BENZAMIDE, 3-(2-IMIDAZO[1,2-B]PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-[4-[(4-METHYL-1-PIPERAZINYL)METHYL]-3-(TRIFLUOROMETHYL)PHENYL]-

BRD-K44227013-001-02-3

BWTNNZPNKQIADY-UHFFFAOYSA-N

C29H27F3N6O

C29H28ClF3N6O

CHEBI:78543

CHEMBL1171837

CHEMBL2105708

CS-0204

CTK5H6398

D09950

D09951

DB08901

DTXSID50149655

DTXSID50241426

EX-A067

FT-0660376

GTPL5890

HMS3654H16

HSDB 8184

HY-12047

Iclusig (TN)

KB-80068

KS-00000772

MLS006010166

MolPort-009-679-483

NCGC00263152-01

NCGC00263152-02

NCGC00263152-14

PB34916

PHXJVRSECIGDHY-UHFFFAOYSA-N

Ponatinb

PONATINIB

Ponatinib (AP24534)

Ponatinib (HCl salt)

Ponatinib (USAN/INN)

Ponatinib [USAN:INN]

Ponatinib HCl

Ponatinib hydrochloride

Ponatinib hydrochloride (JAN/USAN)

Ponatinib hydrochloride [USAN]

Ponatinib Mono-hydrochloride

ponatinibum

Q-4579

QCR-6

RL05926

RT-011294

S1490

SC-53014

SCHEMBL15798559

SCHEMBL589260

SMR004701274

SW218091-2

SYN1116

UNII-4340891KFS

UNII-96R6PU3D8J

X4747

Y1466

ZINC36701290

US Patents and Regulatory Information for ICLUSIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No			Y	Y
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes			Y	Y
Ariad	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No			Y	Y

International Patents for ICLUSIG

Country	Patent Number	Estimated Expiration
China	103467385
World Intellectual Property Organization (WIPO)	2007133560
European Patent Office	2024366
Brazil	PI0710331
China	101389338
European Patent Office	1973545
Japan	2016503010

Supplementary Protection Certificates for ICLUSIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	2013/059	Ireland		PRODUCT NAME: PONATINIB IN ALL FORMS PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545	C 2013 039	Romania		PRODUCT NAME: PONATINIB SI SARURILE SALE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF NATIONAL AUTHORISATION: 20130701; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004; DATE OF FIRST AUTHORISATION IN EEA: 20130701
1973545	PA2013027	Lithuania		PRODUCT NAME: PONATINIBUM; REGISTRATION NO/DATE: EU/1/13/839/001, 2013 07 01 EU/1/13/839/002, 2013 07 01 EU/1/13/839/003, 2013 07 01 EU/1/13/839/004 20130701
1973545	CR 2013 00066	Denmark		PRODUCT NAME: PONATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING THE HYDROCHLORIDE SALT THEREOF; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	490	Finland
1973545	CA 2013 00066	Denmark		PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
1973545	C20130033 00093	Estonia		PRODUCT NAME: PONATINIIB;REG NO/DATE: K(2013)4238 (LOPLIK) 01.07.2013