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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 sixty-eight patent family members in nineteen 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:	68
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	66
Clinical Trials:	13
Patent Applications:	6
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

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

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

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

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

AB0008178

AB01565847_03

ABP000881

AC-26973

AK172051

AKOS015995214

AM81261

AOB87302

AP 24534

AP-24534

AP-24534, Ponatinib, AP24534

AP24534

AP24534 - Ponatinib

AP24534,Ponatinib

AP24534(Ponatinib)

AS-19133

BC659935

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]-

BRD-K44227013-001-02-3

C29H27F3N6O

CHEBI:78543

CHEMBL1171837

CS-0204

CTK5H6398

D09950

D0H0EQ

DB08901

DTXSID50241426

EX-A067

FT-0660376

GTPL5890

HE071231

HE418486

HMS3654H16

HY-12047

Iclusig (TN)

KB-80068

KS-00000772

MFCD17215203

MLS006010166

MolPort-009-679-483

NCGC00263152-01

NCGC00263152-02

PB34916

PHXJVRSECIGDHY-UHFFFAOYSA-N

Ponatinb

PONATINIB

Ponatinib (AP24534)

Ponatinib (USAN/INN)

Ponatinib [USAN:INN]

ponatinibum

Q-4579

QCR-6

RL05926

RT-011294

S1490

SC-53014

SCHEMBL589260

SMR004701274

SYN1116

UNII-4340891KFS

X4747

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

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Non-Orange Book US Patents for ICLUSIG

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,278,971	Substituted acetylenic pyrazolo[1,5-a]pyrimidines as kinase inhibitors
8,278,307	Monocyclic Heteroaryl compounds
8,470,851	Substituted acetylenic imidazo[1,2-A]pyridine compounds as kinase inhibitors

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International Patents for ICLUSIG

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	200870515
Spain	2555515
Slovenia	1973545

Supplementary Protection Certificates for ICLUSIG

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013000152	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
2013 00066	Denmark		PRODUCT NAME: POATINIB, HERUNDER PONATINIB HYDROCHLORID; REG. NO/DATE: EU/1/13/839/001-004 20130701
C0069	France		PRODUCT NAME: PONATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, SOLVATE OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/13/839/001-004 20130701