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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 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 eleven patent family members in fifty-four countries.

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

Summary for axitinib

International Patents:	111
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Suppliers / Packagers:	2
Bulk Api Vendors:	92
Clinical Trials:	105
Patent Applications:	188
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for axitinib
DailyMed Link:	axitinib at DailyMed

Recent Clinical Trials for axitinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
RenJi Hospital	Phase 2
BioGene Pharmaceutical Ltd.	Phase 1/Phase 2
Peking Union Medical College Hospital	Phase 2

See all axitinib clinical trials

Recent Litigation for axitinib

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pfizer Inc. v. Apotex Inc.	2018-05-25

See all axitinib litigation

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

Paragraph IV (Patent) Challenges for AXITINIB

Tradename	Dosage	Ingredient	NDA	Submissiondate
INLYTA	TABLET;ORAL	axitinib	202324	2018-02-23

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
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No			Y	Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes			Y	Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes

International Patents for axitinib

Country	Patent Number	Estimated Expiration
Brazil	0012352
Hong Kong	1085470
Slovenia	1614683
Canada	2383630
Slovakia	286936

Supplementary Protection Certificates for axitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	C01218348/01	Switzerland		FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348	438	Finland
1218348	CA 2013 00010	Denmark
1218348	C 2013 006	Romania		PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903
1218348	2013C/015	Belgium		PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905