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INLYTA Drug Profile

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Which patents cover Inlyta, and when can generic versions of Inlyta launch?

Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in fifty-four countries.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

Summary for INLYTA

International Patents:	111
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	92
Clinical Trials:	30
Patent Applications:	133
Drug Prices:	Drug price information for INLYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INLYTA
DailyMed Link:	INLYTA at DailyMed

See drug prices for INLYTA

Generic Entry Opportunity Date for INLYTA

NDA:

202324

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.

Recent Clinical Trials for INLYTA

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
BioGene Pharmaceutical Ltd.	Phase 1/Phase 2
The University of Hong Kong	N/A

See all INLYTA clinical trials

Recent Litigation for INLYTA

Identify potential future generic entrants

District Court Litigation

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

See all INLYTA litigation

Pharmacology for INLYTA

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Synonyms for INLYTA

(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

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 (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 INLYTA

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
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes
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				Y

Paragraph IV (Patent) Challenges for INLYTA

Drugname	Dosage	Strength	RLD	Date
	Tablets	1 mg and 5 mg

International Patents for INLYTA

Country	Patent Number	Estimated Expiration
Japan	3969669
Hong Kong	1193405
Spain	2293906
Morocco	26803

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2013003,C1218348	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
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	PA2013003	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903