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ICLUSIG Drug Profile

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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-four patent family members in twenty 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.

Summary for ICLUSIG

International Patents:	74
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	80
Clinical Trials:	17
Patent Applications:	68
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ICLUSIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ICLUSIG
Prior Art and Litigation Support	Order Prior Art and Litigation support for ICLUSIG
DailyMed Link:	ICLUSIG at DailyMed

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.

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	203469-002	Dec 14, 2012		RX	Yes	Yes			Y	Y

International Patents for ICLUSIG

Country	Patent Number	Estimated Expiration
Israel	229351
Eurasian Patent Organization	200870514
Australia	2018201013

Supplementary Protection Certificates for ICLUSIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1973545	122013000152	Germany		PRODUCT NAME: PONATINIB "BENZAMID, 3-(2-IMIDAZO(1,2-B)PYRIDAZIN-3-YLETHYNYL)-4-METHYL-N-(4-((4-METHYL-1-PIPERAZINYL)METHYL)-3-(TRIFLUORMETHYL)PHENYL)"; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701
1973545	151 5025-2013	Slovakia		(93) EU/1/13/839/001, EU/1/13/839/002, EU/1/13/839/003, EU/1/13/839/004, 1.7.2013, EU (94) 3.7.2028
1973545	490	Finland