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Axitinib - Generic Drug Details

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What are the generic sources for axitinib and what is the scope of axitinib patent protection?

Axitinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Axitinib has one hundred and ten patent family members in fifty-three countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound.

Summary for axitinib

International Patents:	110
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Suppliers / Packagers:	2
Bulk Api Vendors:	89
Clinical Trials:	100
Patent Applications:	170
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for axitinib
DailyMed Link:	axitinib at DailyMed

Pharmacology for axitinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Synonyms for axitinib

(E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide

(E)-N-methyl-2-(3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-ylthio)benzamide

319460-85-0

460A850

4ag8

4agc

4CA-0215

790713-39-2

AB0008632

AB01274739_02

AB01274739-01

ABP000115

AC-1539

AC1O51X3

AG 013736

AG-013736

AG-013736;Axitinib

AG-13736

AG013736

AG13736

AJ-45709

AK106979

AKOS015902898

AM20090673

AN-501

AOB87786

Axitinib (JAN/USAN)

Axitinib [USAN:INN:JAN]

Axitinib, >=98% (HPLC)

Axitinib,AG-013736

Axitinib/AG013736

Axitinib|319460-85-0|AG 013736|AG013736

axitinibum

BC659937

BCP01371

BCP9000345

BCPP000372

BDBM25117

Benzamide, N-methyl-2-((3-((1E)-2-(2-pyridinyl)ethenyl)-1H-indazo)-6-yl)thio)-

Benzamide, N-methyl-2-[[3-[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-

BRD-K29905972-001-01-4

BRD-K29905972-001-02-2

C22H18N4OS

C9LVQ0YUXG

CAS-319460-85-0

cc-356

CHEBI:66910

CHEBI:94568

CHEMBL1289926

CJ-10777

CS-0116

D03218

DB06626

DSSTox_CID_28975

DSSTox_GSID_49049

DSSTox_RID_83240

DTXSID3049049

EX-A337

GTPL5659

HY-10065

I14-1971

Inlyta

Inlyta (TN)

J-502064

KB-02558

KB-74537

KS-1448

MFCD09837898

MLS006010164

MolPort-006-392-413

N-Methyl-[[3[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-benzamide

N-methyl-2-((3-((1E)-2-(pyridin-2-yl)ethenyl)-1H-indazol-6-yl)sulfanyl)benzamide

N-methyl-2-({3-[(E)-2-(pyridin-2-yl)ethenyl]-1H-indazol-6-yl}sulfanyl)benzamide

N-methyl-2-({3-[(E)-2-(pyridin-2-yl)vinyl]-1H-indazol-6-yl}sulfanyl)benzamide

N-methyl-2-({3-[(E)-2-pyridin-2-ylethenyl]-2H-indazol-6-yl}sulfanyl)benzamide

N-METHYL-2-(3-((E)-2-PYRIDIN-2-YL-VINYL)-1H-INDAZOL-6-YLSULFANYL)-BENZAMIDE

N-methyl-2-[[3-[(E)-2-(2-pyridyl)vinyl]-1H-indazol-6-yl]sulfanyl]benzamide

N-methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide

NCGC00241108-01

NCGC00241108-04

NCGC00241108-06

NSC-757441

NSC757441

Q-200662

Q-3279

QCR-109

RL03128

S1005

SB20061

SC-22491

SCHEMBL172918

SMR002530046

SR-01000941566

SR-01000941566-1

SW219464-1

SYN1014

Tox21_113597

Tox21_113597_1

TR-013491

UNII-C9LVQ0YUXG

ZINC3816287

US Patents and Regulatory Information for axitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes			Y	Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No			Y	Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No

International Patents for axitinib

Country	Patent Number	Estimated Expiration
Croatia	P20020109
Czech Republic	20014634
Luxembourg	92154
Australia	2008236444
Colombia	5190686
Mexico	2009010761
Georgia, Republic of	P20063885

Supplementary Protection Certificates for axitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	PA2013003,C1218348	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	C300576	Netherlands		PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348	5/2013	Austria		PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	C01218348/01	Switzerland		FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348	CR 2013 00010	Denmark		PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348	122013000016	Germany		PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903