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STIVARGA Drug Profile

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

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

This drug has two hundred and seventy patent family members in fifty-eight countries.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Summary for STIVARGA

International Patents:	270
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	83
Clinical Trials:	43
Patent Applications:	68
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIVARGA
DailyMed Link:	STIVARGA at DailyMed

Pharmacology for STIVARGA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 2C9 Inhibitors

Synonyms for STIVARGA

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

24T2A1DOYB

4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl}amino)-3-fluorophenoxy)-N-methylpyridine-2-carboxamide

4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)-N-methylpicolinamide

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

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

4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carbox

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

4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide

4CA-1083

755037-03-7

835621-08-4

A25020

AB0008044

AB01565826_02

AB1008457

ABP000611

AC-25075

AJ-56815

AK106990

AKOS015951107

AM81251

anhydrous regorafenib

AOB87754

AS-16304

AX8232295

BAY 73-4506

BAY 734506

BAY-73-4506

BAY-734506 monohydrate

BAY73-4506

BAY73-4506 hydrochloride

BAY73-4506(Regorafenib)/

BCP9000384

BCPP000352

BDBM50363397

C21H15ClF4N4O3

cas:835621-07-3;Regorafenib hydrochloride

CHEBI:68647

CHEMBL1946170

CJ-13100

CS-0170

D09GDD

D10138

DB08896

DTXSID60226441

EX-A058

FNHKPVJBJVTLMP-UHFFFAOYSA-N

FT-0674338

GTPL5891

HE070021

HE386186

HMS3654K16

HY-10331

KB-80344

KS-00000Q4Q

MFCD16038047

MLS006010303

MolPort-009-679-472

NCGC00263138-01

QCR-85

R0142

Regorafenib

Regorafenib - BAY 73-4506

Regorafenib (BAY 73-4506)

Regorafenib (BAY73-4506 Fluoro-Sorafenib)

Regorafenib (USAN/INN)

Regorafenib [USAN:INN]

Regorafenib, 755037-03-7

Regorafenib,BAY 73-4506

Regorafenib;1-(4-chloro-3-(trifluoromethyl)phenyl)-3-(2-fluoro-4-(2-(methylcarbamoyl)pyridin-4-yloxy)phenyl)urea

Regorafenib(BAY 73-4506)

RegorafenibBAY73-4506

Regorafenibum

RL04875

S-7780

s1178

SC-28977

SCHEMBL432230

SMR004701370

SR-01000941571

SR-01000941571-1

ST24023156

Stivarga (TN)

SYN1169

UNII-24T2A1DOYB

ZINC6745272

US Patents and Regulatory Information for STIVARGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes			Y	Y
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes

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Paragraph IV (Patent) Challenges for STIVARGA

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	40 mg		2016-09-27

Non-Orange Book US Patents for STIVARGA

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
8,124,630	.omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
8,748,622	Process for the preparation of 4-{4[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluor- ophenoxy}-N-methylpyridine-2-carboxamide, its salts and monohydrate
7,528,255	Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors
7,928,239	Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas

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International Patents for STIVARGA

Country	Document Number	Estimated Expiration
Germany	60026822
Cuba	20120147
Guatemala	200400140
Spain	2384160

Supplementary Protection Certificates for STIVARGA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0130034 00099	Estonia		PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
13/050	Ireland		PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
2006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719