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STIVARGA Drug Patent Profile

When do Stivarga patents expire, and when can generic versions of Stivarga launch?

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

This drug has one hundred and sixty-seven patent family members in forty-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.

DrugPatentWatch^® Generic Entry Outlook for Stivarga

Stivarga was eligible for patent challenges on September 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 8, 2031. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STIVARGA

International Patents:	167
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	81
Patent Applications:	2,998
Drug Prices:	Drug price information for STIVARGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIVARGA
What excipients (inactive ingredients) are in STIVARGA?	STIVARGA excipients list
DailyMed Link:	STIVARGA at DailyMed

See drug prices for STIVARGA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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
Great Novel Therapeutics Biotech & Medicals Corporation	Phase 1/Phase 2
Anshan Tumor Hospital	Phase 1/Phase 2
University of Miami	Phase 2

See all STIVARGA clinical trials

Pharmacology for STIVARGA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Kinase Inhibitors UGT1A1 Inhibitors UGT1A9 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for STIVARGA

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for STIVARGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIVARGA	Tablets	regorafenib	40 mg	203085	2	2016-09-27

US Patents and Regulatory Information for STIVARGA

STIVARGA is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting STIVARGA

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

Expired US Patents for STIVARGA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012

EU/EMA Drug Approvals for STIVARGA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer Pharma AG	Stivarga	regorafenib	EMEA/H/C/002573 Stivarga is indicated as monotherapy for the treatment of adult patients with:metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy;unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.	Authorised	no	no	no	2013-08-26

International Patents for STIVARGA

When does loss-of-exclusivity occur for STIVARGA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Denmark

Dominican Republic

Ecuador

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering STIVARGA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2558448	PROCÉDÉ DE PRÉPARATION DE 4-{4-[({[4-CHLORO-3-(TRIFLUOROMÉTHYL)-PHÉNYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHÉNOXY}-N-MÉTHYLPYRIDINE-2-CARBOXAMIDE, SES SELS ET SON MONOHYDRATE (PROCESS FOR THE PREPARATION OF 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)-PHENYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE, ITS SALTS AND MONOHYDRATE)
Canada	2609389	TRAITEMENT DE COMBINAISON COMPRENANT UN COMPOSE DIARYLUREE ET DES INHIBITEURS DE PI3- OU AKT-KINASE OU DE MTOR (RAPAMYCINES) POUR LE TRAITEMENT DU CANCER (COMBINATION THERAPY COMPRISING A DIARYL UREA COMPOUND AND A PI3, AKT KINASE OR MTOR INHIBITORS (RAPAMYCINS) FOR CANCER TREATMENT)
South Korea	20170129276	４―｛４―［（｛［４-클로로―３―（트리플루오로메틸）―페닐］아미노｝카르보닐）아미노］―３―플루오로페녹시｝―Ｎ―메틸피리딘―２―카르복스아미드, 그의 염 및 일수화물의 제조 방법 (- PROCESS FOR THE PREPARATION OF 4-4-4-CHLORO-3-TRIFLUOROMETHYL-PHENYL]AMINOCARBONYLAMINO-3-FLUOROPHENOXY-N-METHYLPYRIDINE-2-CARBOXAMIDE ITS SALTS AND MONOHYDRATE)
Cuba	23213	DIFENILUREAS SUSTITUIDAS CON OMEGA-CARBOXIARILO COMO INHIBIDORES DE RAF QUINASA
Germany	05028442

Supplementary Protection Certificates for STIVARGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663978	C 2014 007	Romania		PRODUCT NAME: REGORAFENIB SI SARURILE SALE4-[4-({[4-CLORO-3-(TRIFLUOROMETIL)-FENIL]CARBAMOIL}AMINO)-TIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/858; DATE OF FIRST AUTHORISATION IN EEA: 20130826 3-FLUOROFENOXI]-N-METILPIRIDIN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/13/858; DATE OF NA
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
1663978	C300620	Netherlands		PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978	1390050-1	Sweden		PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28
1663978	149 13-2013	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826