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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-four 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:	274
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	96
Clinical Trials:	60
Patent Applications:	77
Drug Prices:	Drug price information for STIVARGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIVARGA
DailyMed Link:	STIVARGA at DailyMed

See drug prices for STIVARGA

Generic Entry Opportunity Date for STIVARGA

NDA:

203085

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 STIVARGA

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

Sponsor	Phase
Centre Leon Berard	N/A
Liaoning Tumor Hospital & Institute	Phase 1/Phase 2
The First People's Hospital of Jingzhou	Phase 1/Phase 2

See all STIVARGA clinical trials

Recent Litigation for STIVARGA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Bayer Healthcare LLC v. Apotex, Inc.	2018-09-21
Bayer Healthcare LLC v. Apotex, Inc.	2016-12-16
Bayer Healthcare LLC v. Apotex Inc.	2016-12-16

See all STIVARGA litigation

PTAB Litigation

Petitioner	Date
Fustibal LLC	2016-07-25

See all STIVARGA litigation

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

ACN-036634

AJ-56815

AKOS015951107

AM81251

AOB87754

AS-16304

AX8232295

BAY 73-4506

BAY 73-4506; Stivarga

BAY 734506

BAY-73-4506

BAY-734506 monohydrate

BAY73-4506

BAY73-4506 hydrochloride

BAY73-4506(Regorafenib)/

BCP02105

BCP9000384

BCPP000352

BDBM50363397

BRD-K16730910-001-02-4

C21H15ClF4N4O3

cas:835621-07-3;Regorafenib hydrochloride

CHEBI:68647

CHEMBL1946170

CJ-13100

CS-0170

D10138

DB08896

DTXSID60226441

EX-A058

FNHKPVJBJVTLMP-UHFFFAOYSA-N

FT-0674338

GTPL5891

HMS3654K16

HY-10331

KB-80344

KS-00000Q4Q

MLS006010303

MolPort-009-679-472

NCGC00263138-01

NCGC00263138-13

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

SB16819

SC-28977

SCHEMBL432230

SMR004701370

SR-01000941571

SR-01000941571-1

ST24023156

Stivarga (TN)

SW218097-2

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
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes			Y
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes				Y
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes

Paragraph IV (Patent) Challenges for STIVARGA

Drugname	Dosage	Strength	RLD	Date
	Tablets	40 mg

International Patents for STIVARGA

Country	Patent Number	Estimated Expiration
Czech Republic	20012489
Slovakia	287419
Malaysia	162359
Israel	253119
Peru	08382016
Israel	197369
Slovenia	2558448

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	SPC/GB13/076	United Kingdom		PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTERED: UK EU/1/13/858/001 20130829; UK EU/1/13/858/002 20130829
1140840	PA 2006 008, C 1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1663978	1390050-1	Sweden		PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28
1140840	295	Finland
1140840	35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	122006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719