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NEXAVAR Drug Profile

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When do Nexavar patents expire, and what generic alternatives are available?

Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twelve patent family members in fifty-six countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

Summary for NEXAVAR

International Patents:	212
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	96
Clinical Trials:	276
Patent Applications:	4,465
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXAVAR
DailyMed Link:	NEXAVAR at DailyMed

Generic Entry Opportunity Date for NEXAVAR

NDA:

021923

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.

Pharmacology for NEXAVAR

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for NEXAVAR

1-(4-(2-(METHYLCARBAMOYL)PYRIDIN-4-YLOXY)PHENYL)-3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREA

100012-18-8

15216-EP2272827A1

15216-EP2298778A1

15216-EP2311840A1

15216-EP2316832A1

15216-EP2316833A1

1uwh

2-PYRIDINECARBOXAMIDE 4-[4-[[[[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]AMINO]CARBONYL]AMINO]PHENOXY]-N-METHYL-

2-Pyridinecarboxamide, 4-(4-((((4-chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-

2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-

284461-73-0

3gcs

3heg

4-?[4-?[[[[4-?CHLORO-?3-?(TRIFLUOROMETHYL)PHENYL]AMINO]CARBONYL]AMINO]PHENOXY]-?N-?METHYL-?2-?PYRIDINECARBOXAMIDE

4-(4-((((4-Chloro-3-(trifluoromethyl)phenyl)amino)carbonyl)amino)phenoxy)-N-methyl-2-pyridinecarboxamide

4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido) phenoxy)-N-methylpicolinamide

4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl) ureido)phenoxy)-N-methylpicolinamide

4-(4-(3-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)UREIDO)PHENOXY)-N-METHYLPICOLINAMIDE

4-(4-(3-(4-chloro-3-trifluoromethylphenyl)ureido)phenoxy)pyridine-2-carboxyllic acid methyamide-4-methylbenzenesulfonate

4-(4-[3-(4-CHLORO-3-TRIFLUOROMETHYL-PHENYL)-UREIDO]-PHENOXY)-PYRIDINE-2-CARBOXYLIC ACID METHYLAMIDE

4-(4-{3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide

4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide

4-[4-([[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL]AMINO)PHENOXY]-N-METHYL-2-PYRIDINECARBOXAMIDE

4-[4-([[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]CARBAMOYL]AMINO)PHENOXY]-N-METHYLPYRIDINE-2-CARBOXAMIDE

4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide

4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide

4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-picolinamide;tosylic acid

4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methyl-pyridine-2-carboxamide

4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide

4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)-amino]phenoxy}-N-methylpyridine-2-carboxamide

4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-N-methyl-pyridine-2-carboxamide

4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL]AMINO}CARBONYL)AMINO]PHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE

4(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N(sup 2)-methylpyridine-2-carboxamide

461S730

4asd

9ZOQ3TZI87

AB0019677

AB00933189_08

AB00933189-05

AB00933189-06

AB1004622

AC-1674

AC1L50CF

ACN-032355

ACT06732

AK163019

AKOS005560229

AM20090614

AN-613

AOB87782

BAY 43-9006

BAY 439006

BAY 545-9085

BAY-43-0006

BAY-43-9006

BAY-54-9085

BAY-545-9085

BAY43-9006

BAY439006

BC679588

BCPP000064

BDBM16673

Bio-0100

BRD-K23984367-001-01-8

CHEBI:50924

CHEMBL1336

cid_216239

CS-1590

CS0056

D08524

D0W5HK

DB00398

DTXSID7041128

EN002709

FT-0650736

GTPL5711

HE069468

HE200290

Hit compound, 8

HMS2043A18

HMS3244A15

HMS3244A16

HMS3244B15

HMS3656N20

HY-10201

I06-0856

J10391

K00597a

KB-60586

KB-80670

Kinome_766

KS-0000009E

LS-186067

LS-187021

LS-187788

MCULE-6112506696

MFCD06411450

MLDQJTXFUGDVEO-UHFFFAOYSA-N

MolPort-003-850-270

N-(3-trifluoromethyl-4-chlorophenyl)-N'-(4-(2-methylcarbamoyl pyridin-4-yl)oxyphenyl)urea

N-(4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)-((4-(2-(N-METHYL-CARBAMOYL)(4-PYRIDYLOXY))PHENYL)AMINO)CARBOXAMIDE

N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcar bamoyl)-4-pyridyloxy)phenyl)urea

N-(4-chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl) urea

N-(4-Chloro-3-(trifluoromethyl)phenyl)-N'-(4-(2-(N-methylcarbamoyl)-4-pyridyloxy)phenyl)urea

N-[4-Chloro-3-(trifluoromethyl)phenyl]-N'-[4-[2-(N-methylcarbamoyl)-4-pyridyloxy]phenyl]urea

N-[4-Chloro-3-(trifluoromethyl)phenyl]-N'-[4-[2-(N-methylcarbamoyl)-4-pyridyloxy]phenyl]urea; 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide

NCGC00167488-01

NCGC00167488-02

NCGC00167488-03

NCGC00167488-04

NCGC00167488-05

NCGC00167488-07

Nexavar (TN)

Nexavar (TN) (Bayer)

Nexavar|||BAY 43-9006

NSC-724772

NSC-747971

NSC747971

OR252811

PB14443

Q-201728

QCR-65

RAF1 KINASE INHIBITOR II

RS0103

s7397

SC-19355

SCHEMBL8218

SF-0529

Sorafenib

Sorafenib (INN)

Sorafenib (Nexavar)

Sorafenib (Pan-TK inhibitor)

Sorafenib (USAN/INN)

Sorafenib [INN]

Sorafenib [USAN:INN:BAN]

SORAFENIB BASE

Sorafenib free base (BAY-43-9006)

Sorafenib tosilate

Sorafenib-d3

Sorafenib, 4

Sorafenibtosylate

sorafenibum

Sorafinib

SR-00000000529

SR-00000000529-1

STK627350

SYN1082

UNII-9ZOQ3TZI87

Z89277543

ZINC1493878

US Patents and Regulatory Information for NEXAVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes			Y	Y
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes			Y	Y

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Paragraph IV (Patent) Challenges for NEXAVAR

Drugname	Dosage	Strength	RLD	Date
	Tablets	200 mg

Non-Orange Book US Patents for NEXAVAR

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
7,528,255	Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors
7,838,541	Aryl ureas with angiogenesis inhibiting activity
7,928,239	Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas
8,242,147	Aryl ureas with angiogenisis inhibiting activity

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International Patents for NEXAVAR

Country	Document Number	Estimated Expiration
Japan	2008514658
Austria	460398
European Patent Office	1478358
South Korea	20130004385

Supplementary Protection Certificates for NEXAVAR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0034	France		PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
C 031/2006	Ireland		SPC 031/2006: 20070528, EXPIRES: 20210718
2006008,C1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
280	Luxembourg		91280, EXPIRES: 20210720