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Pazopanib hydrochloride - Generic Drug Details

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What are the generic drug sources for pazopanib hydrochloride and what is the scope of pazopanib hydrochloride patent protection?

Pazopanib hydrochloride is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pazopanib hydrochloride has forty patent family members in twenty-five countries.

There are three drug master file entries for pazopanib hydrochloride. One supplier is listed for this compound.

Summary for pazopanib hydrochloride

International Patents:	40
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	63
Clinical Trials:	258
Patent Applications:	99
Formulation / Manufacturing:	see details
DailyMed Link:	pazopanib hydrochloride at DailyMed

Pharmacology for pazopanib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 2C8 Inhibitors

Synonyms for pazopanib hydrochloride

33Y9ANM545

5-((4-((2,3-DIMETHYL-2H-INDAZOL-6-YL)(METHYL)AMINO)PYRIMIDIN-2-YL)AMINO)-2-METHYLBENZENESULFONAMIDE HYDROCHLORIDE

5-((4-((2,3-Dimethyl-2H-indazol-6-yl)methylamino)pyrimidin-2-yl)amino)-2-methylbenzenesulfonamide monohydrochloride

5-({4-[(2,3-dimethyl-2H-indazol-6-yl)(methyl)amino]-2-pyrimidinyl}amino)-2-methylbenzenesulfonamide Hydrochloride

5-({4-[(2,3-dimethyl-2H-indazol-6-yl)(methyl)amino]pyrimidin-2-yl}amino)-2-methylbenzenesulfonamide hydrochloride

5-({4-[(2,3-dimethylindazol-6-yl)(methyl)amino]pyrimidin-2-yl}amino)-2-methylbenzenesulfonamide hydrochloride

5-(4-((2,3-dimethyl-2H-indazol-6-yl)(methyl)amino)pyrimidin-2-ylamino)-2-methylbenzenesulfonamide hydrochloride

5-[[4-[(2,3-dimethyl-6-indazolyl)-methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride

5-[[4-[(2,3-dimethylindazol-6-yl)-methyl-amino]pyrimidin-2-yl]amino]-2-methyl-benzenesulfonamide hydrochloride

635702-64-6

786034 HYDROCHLORIDE

A834417

AC-24726

AK163181

AKOS015958593

AM20090655

AN-16933

Armala

ARMALA HYDROCHLORIDE

AX8294838

BCP9001052

Benzenesulfonamide, 5-((4-((2,3-dimethyl-2H-indazol-6-yl)methylamino)-2-pyrimidinyl)amino)-2-methyl-, monohydrochloride

Benzenesulfonamide, 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methyl-, hydrochloride (1:1)

C21H23N7O2S.HCl

CHEBI:71217

CHEMBL1201733

CS-0126

D05380

DTXSID70212956

EX-A956

FT-0687642

GSK-786034

GW 786034

GW 786034 HYDROCHLORIDE

GW-786034B

GW786034B

GW786034GW786034

HY-12009

KB-79770

KS-000003E0

KS-1458

MFCD12546138

MLS004774147

MolPort-009-679-403

MQHIQUBXFFAOMK-UHFFFAOYSA-N

NSC-737754

NSC737754

Patorma

Pazopanib (Hydrochloride)

pazopanib HCl

Pazopanib HCl (GW786034 )

Pazopanib HCl (GW786034 HCl)

Pazopanib hydrochloride (JAN/USAN)

Pazopanib hydrochloride [USAN:JAN]

pazopanib monohydrochloride

PB31655

S1035

SC-90768

SCHEMBL159487

SMR003500790

ST24048877

SYN1058A

UNII-33Y9ANM545

Votrient

Votrient (TN)

VOTRIENT HYDROCHLORIDE

W-5532

X3177

US Patents and Regulatory Information for pazopanib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	No	No
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	No	No			Y	Y
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	No	No			Y	Y
Novartis Pharms Corp	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	No	No			Y	Y

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Non-Orange Book US Patents for pazopanib hydrochloride

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
7,858,626	Pyrimidineamines as angiogenesis modulators

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International Patents for pazopanib hydrochloride

Country	Document Number	Estimated Expiration
Portugal	2311825
European Patent Office	1343782
Israel	156306
Hungary	S1700003
Portugal	1343782
South Korea	20040011448

Supplementary Protection Certificates for pazopanib hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
9	Finland
2010 00024	Denmark		PRODUCT NAME: PAZOPANIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER HYDROCLORID
710	Luxembourg		91710, EXPIRES: 20250614
/2010	Austria		PRODUCT NAME: PAZOPANIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/10/628/001 - EU/1/10/628/004 20100614
C0037	France		PRODUCT NAME: PAZOPANIB; REGISTRATION NO/DATE: EU/1/110/628/001 20100614
C/GB10/032	United Kingdom		PRODUCT NAME: PAZOPANIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU 1/10/628/001 20100614; UK EU 1/10/628/002 20100614; UK EU 1/10/628/003 20100614; UK EU 1/10/628/004 20100614