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NERLYNX Drug Profile

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Which patents cover Nerlynx, and what generic alternatives are available?

Nerlynx is a drug marketed by Puma Biotech and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and six patent family members in twenty-one countries.

The generic ingredient in NERLYNX is neratinib maleate. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.

Summary for NERLYNX

International Patents:	106
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	83
Clinical Trials:	3
Patent Applications:	130
Drug Prices:	Drug price information for NERLYNX
DailyMed Link:	NERLYNX at DailyMed

See drug prices for NERLYNX

Generic Entry Opportunity Date for NERLYNX

NDA:

208051

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 NERLYNX

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

Sponsor	Phase
Puma Biotechnology, Inc.	Phase 1/Phase 2
Virginia Commonwealth University	Phase 1/Phase 2
NSABP Foundation Inc	Phase 2

See all NERLYNX clinical trials

Pharmacology for NERLYNX

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors P-Glycoprotein Inhibitors

Synonyms for NERLYNX

(2e)-n-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide

(2e)-n-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide neratinib

(2E)-N-[4-[[3-chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide

(2E)-N-[4-[[3-chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide;HKI-272

(E)-N-(4-((3-Chloro-4-(pyridin-2-ylmethoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide

(E)-N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylami

(E)-N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide

(E)-N-[4-[3-chloro-4-(2-pyridylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolyl]-4-(dimethylamino)but-2-enamide

2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-

387N096

4-Dimethylamino-but-2-enoic acid {4-[3-chloro-4-(pyridin-2-ylmethoxy)-phenylamino]-3-cyano-7-ethoxy-quinolin-6-yl}-amide

698387-09-6

698387-09-6, HKI272, HKI 272, HKI-272,

736156-77-7

A25338

AB0008022

ABP000871

AC-25073

AK170454

AKOS005146340

AKOS025149637

AN-546

AOB87125

AS-16279

BC256322

BCP9000984

BCPP000151

BDBM50161957

BIFK0031

BRD-K85606544-001-01-8

C30H29ClN6O3

cc-32

CDP-820

CHEMBL180022

D08950

DB11828

DTXSID70220132

EX-A062

GTPL5686

HKI 272

HKI-272

HY-32721

I06-2375

JJH94R3PWB

JSPY-st000262

KB-58129

MolPort-006-069-389

N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide

NCGC00241101-01

NCGC00241101-03

Neratinib

Neratinib - HKI-272

Neratinib (HKI-272)

Neratinib (USAN/INN)

Neratinib [USAN:INN]

Neratinib HKI 272

Neratinib(HKI-272)

Neratinib(HKI-272)/HKI272

PB 272

PB-272

PubChem22399

Q-101402

QCR-104

RL04677

s2150

SB16595

SC-28031

SCHEMBL571762

SCHEMBL571763

SYN1140

Tube708

UNII-JJH94R3PWB

WAY-179272

WAY-179272-B

X2638

Z-3202

ZINC3916214

ZX-AFC000299

US Patents and Regulatory Information for NERLYNX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y	Y
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y	Y
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes

Expired US Patents for NERLYNX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017

International Patents for NERLYNX

Country	Patent Number	Estimated Expiration
European Patent Office	2537843
Australia	2010316683
South Korea	20140036332
Japan	2011098964
Japan	2012522837
Japan	2018109071