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CAPRELSA Drug Profile

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When do Caprelsa patents expire, and when can generic versions of Caprelsa launch?

Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in forty-two countries.

The generic ingredient in CAPRELSA is vandetanib. Two suppliers are listed for this compound. Additional details are available on the vandetanib profile page.

Summary for CAPRELSA

International Patents:	137
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	96
Clinical Trials:	15
Patent Applications:	3,129
Formulation / Manufacturing:	see details
DailyMed Link:	CAPRELSA at DailyMed

Pharmacology for CAPRELSA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors P-Glycoprotein Inhibitors Organic Cation Transporter 2 Inhibitors

Synonyms for CAPRELSA

(4-Bromo-2-fluoro-phenyl)-[6-methoxy-7-(1-methyl-piperidin-4-ylmethoxy)-quinazolin-4-yl]-amine

2ivu

338992-00-0

4-(4-Bromo-2-fluoroanilino)-6-methoxy- 7-[(1-methylpiperidin-4-yl)methoxy]quinazoline

4-(4-Bromo-2-fluoroanilino)-6-methoxy-7-(1-methylpiperidin-4-yl)methoxyquinazoline

4-(4-bromo-2-fluoroanilino)-6-methoxy-7-(1-methylpiperidin-4-ylmethoxy)quinazoline

4-(4-Bromo-2-fluoroanilino)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy]quinazoline

4-[(4-Bromo-2-fluorophenyl)amino]-6-methoxy-7-[(1-methyl-4-piperidyl)methoxy]quinazoline

4-BROMO-2-FLUORO-N-[(4E)-6-METHOXY-7-[(1-METHYLPIPERIDIN-4-YL)METHOXY]QUINAZOLIN-4(1H)-YLIDENE]ANILINE

4-Quninazolinamine, N-(4-bromo-2-fluorophenyl)-6-methoxy-7-((1-methyl-4-piperidinyl)methoxy)-

443913-73-3

68541-EP2298768A1

68541-EP2308855A1

913V733

A25648

AB0008635

AB01273969_04

AB01273969-01

AB01273969-02

AB1008463

ABP000873

AC-5251

AC1MIWRU

AJ-45811

AK106976

AKOS015902350

AN-3469

ANW-61824

AOB87780

AS-11067

AZD-6474

BC224441

BCPP000023

BDBM21

C22H24BrFN4O2

Caprelsa (TN)

CAS-443913-73-3

CH 331

CH-331

CHEBI:49960

CHEMBL24828

cid_3081361

CS-0130

CTK8B9016

D06407

D0G6QF

DB05294

DMPC Cyclic Urea 1

DSSTox_CID_26681

DSSTox_GSID_46681

DSSTox_RID_81816

DTXSID1046681

EN002713

EX-A422

F9995-0087

FT-0656736

GNF-PF-2188

GTPL5717

HE069787

HE343618

HMS3244K03

HMS3244K04

HMS3244L03

HMS3654E11

HSDB 8198

HY-10260

I14-1942

KB-34269

Kinome_3316

LS-184394

MCULE-4705827953

MFCD07772346

MLS006011672

MolPort-005-942-399

N-(4-bromo-2-fluoro-phenyl)-6-methoxy-7-[(1-methyl-4-piperidyl)methoxy]quinazolin-4-amine

N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-((1-methyl-4-piperidinyl)methoxy)-4-quinazolinamine

N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-((1-methylpiperidin-4-yl)methoxy)quinazolin-4-amine

N-(4-Bromo-2-fluorophenyl)-6-methoxy-7-[(1-methyl-4-piperidinyl)methoxy]-4-quinazolinamine

N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl)methoxy]quinazolin-4-amine

NCGC00167513-01

NCGC00167513-02

NCGC00167513-03

NCGC00167513-04

NSC-744325

NSC-760766

NSC744325

NSC760766

PubChem22460

QCR-37

Quinazolin-4-amine, N-(4-bromo-2-fluorophenyl)-6-mthoxy-7-[(1-methyl-4-piperidinyl)methoxy]-

RS0036

RT-016214

s1046

SC-23330

SCHEMBL9044

SMR002530472

SR-00000000462

SR-00000000462-2

ST2407381

SYN1090

Tox21_112511

Tox21_112511_1

UHTHHESEBZOYNR-UHFFFAOYSA-N

UNII-YO460OQ37K

V-9402

Vandetanib

Vandetanib (JAN/INN)

Vandetanib (JAN/USAN/INN)

Vandetanib (Pan-TK inhibitor)

vandetanib (zd6474)

Vandetanib [INN]

Vandetanib [USAN:INN:BAN:JAN]

Vandetanib, Zactima, ZD6474

Vandetanib;7-((4-aminocyclohexyl)methoxy)-N-(4-bromo-2-fluorophenyl)-6-methoxyquinazolin-4-amine

Vandetanib(Zactima),ZD6474/

Vandetinib

W-5356

YO460OQ37K

Zactima

Zactima, ZD6474

ZD 6474

ZD-64

ZD-6474

ZD6474

ZINC53683345

US Patents and Regulatory Information for CAPRELSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes			Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011		RX	Yes	No			Y	Y
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011		RX	Yes	Yes			Y	Y

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Expired US Patents for CAPRELSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-002	Apr 6, 2011
Genzyme Corp	CAPRELSA	vandetanib	TABLET;ORAL	022405-001	Apr 6, 2011

Non-Orange Book US Patents for CAPRELSA

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
6,673,803	Quinazoline derivatives and pharmaceutical compositions containing them
9,040,548	Quinazoline derivatives as VEGF inhibitors
6,897,210	Quinazoline derivatives and pharmaceutical compositions containing them
6,414,148	Quinazoline derivatives and pharmaceutical compositions containing them

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International Patents for CAPRELSA

Country	Document Number	Estimated Expiration
Norway	313138
South Korea	100618065
Norway	2012014
Hong Kong	1099220

Supplementary Protection Certificates for CAPRELSA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012000057	Germany		PRODUCT NAME: VANDETANIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
9	Finland
0543	Netherlands		PRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
1244647/01	Switzerland		FORMER OWNER: ASTRAZENECA AB, SE