You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

~ Buy the STIVARGA (regorafenib) Drug Profile, 2024 PDF Report in the Report Store ~

STIVARGA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for STIVARGA
Drug Prices for STIVARGA

See drug prices for STIVARGA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STIVARGA
Generic Entry Date for STIVARGA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Great Novel Therapeutics Biotech & Medicals CorporationPhase 1/Phase 2
The Second Affiliated Hospital of Dalian Medical UniversityPhase 1/Phase 2
Benxi Cental HospitalPhase 1/Phase 2

See all STIVARGA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIVARGA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment of cancers with acquired resistance to kit inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST), INCLUDING BUT NOT LIMITED TO PATIENTS PREVIOUSLY TREATED WITH IMATINIB AND PATIENTS WITH GIST HAVING RESISTANCE TO A KIT TYROSINE KINASE INHIBITOR

Process for the preparation of 4-{4-[({[4 chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluorphenoxy-N-- ethylpyridie-carboxamide, its salts and monohydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting STIVARGA

TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC OR LIVER CANCER) WHO HAVE BEEN PREVIOUSLY TREATED WITH THE DRUG SORAFENIB.
Exclusivity Expiration: ⤷  Try a Trial

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 1060
Estimated Expiration: ⤷  Try a Trial

Patent: 6395
Patent: 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDIN-2-CARBOXAMIDA, SU MONOHIDRATO O SAL EN UNA FORMA DE PUREZA ALTA
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11240113
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012026117
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 96238
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12002840
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2947271
Estimated Expiration: ⤷  Try a Trial

Patent: 3980191
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 30136
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120526
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150885
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 123
Estimated Expiration: ⤷  Try a Trial

Patent: 120147
Estimated Expiration: ⤷  Try a Trial

Patent: 140060
Patent: 4-{4-[({[ 4- CLORO-3-( TRIFLUOROMETIL) FENIL] AMINO} CARBONIL) AMINO]-3- FLUOROFENOXI}-N-METILPIRIDINA-2- CARBOXAMIDA Y SU MONOHIDRATO
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 58448
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 012000268
Estimated Expiration: ⤷  Try a Trial

Patent: 016000285
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 12012234
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58448
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1200280
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 00831
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 26821
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2348
Estimated Expiration: ⤷  Try a Trial

Patent: 3119
Patent: 4-{4[({[4-כלורו-3-(טריפלואורוצתיל) פניל]אמינו}קרבוניל)אמינו]-3-פלואורופנוקסי}-n-מתילפירידין-2-קרבוקסאמיד, המלחים ומונוהידרט שלו ותכשירים הכוללים אותו (4-{4-[({[4-chloro-3-(trifluoromethyl)lphenyl]amino}carbonyl)amino]-3-fluorophenoxy}-n-methylpyridine-2-carboxamide, its salts and monohydrate and compositions comprising the same)
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 34182
Estimated Expiration: ⤷  Try a Trial

Patent: 13523851
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 58
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2359
Estimated Expiration: ⤷  Try a Trial

Patent: 7066
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 12011734
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 156
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2997
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 130181
Estimated Expiration: ⤷  Try a Trial

Patent: 160838
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 58448
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 58448
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 81585
Estimated Expiration: ⤷  Try a Trial

Patent: 12148386
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 219
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 4172
Estimated Expiration: ⤷  Try a Trial

Patent: 201501221U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 58448
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1800041
Estimated Expiration: ⤷  Try a Trial

Patent: 130061670
Estimated Expiration: ⤷  Try a Trial

Patent: 170129276
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 42610
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 75992
Estimated Expiration: ⤷  Try a Trial

Patent: 39951
Estimated Expiration: ⤷  Try a Trial

Patent: 1204356
Estimated Expiration: ⤷  Try a Trial

Patent: 1509415
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 12000492
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 0613
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 290
Estimated Expiration: ⤷  Try a Trial

Patent: 590
Estimated Expiration: ⤷  Try a Trial

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
Spain 2372020 ⤷  Try a Trial
Montenegro 00275 ω-KARBOKSIARIL SUPSTITUISANI DIFENIL KARBAMIDI KAO INHIBITORI RAF KINAZE (?-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS) ⤷  Try a Trial
Serbia 52625 FLUORO SUPSTITUISANA OMEGA-KARBOKSIARIL DIFENIL UREA ZA LEČENJE I PREVENCIJU BOLESTI I STANJA BOLESTI (FLUORO SUBSTITUTED OMEGA-CARBOXYARYL DIPHENYL UREA FOR THE TREATMENT AND PREVENTION OF DISEASES AND CONDITIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008043446 ⤷  Try a Trial
Russian Federation 2319693 ПРОИЗВОДНЫЕ МОЧЕВИНЫ (ВАРИАНТЫ), ФАРМАЦЕВТИЧЕСКАЯКОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЯ, СВЯЗАННОГО С РОСТОМ РАКОВЫХ КЛЕТОК (ВАРИАНТЫ) (DERIVATIVES OF UREA (VARIANTS), PHARMACEUTICAL COMPOSITION (VARIANTS) AND METHOD FOR TREATMENT OF DISEASES ASSOCIATED WITH CANCER CELLS GROWTH (VARIANTS)) ⤷  Try a Trial
Netherlands 300242 ⤷  Try a Trial
Canada 2675980 TRAITEMENT DE CANCERS A RESISTANCE ACQUISE AUX INHIBITEURS KIT (TREATMENT OF CANCERS WITH ACQUIRED RESISTANCE TO KIT INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STIVARGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663978 2013C/067 Belgium ⤷  Try a Trial PRODUCT NAME: STIVARGA-REGORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/13/858 20130829
1140840 295 Finland ⤷  Try a Trial
1140840 SPC/GB07/004 United Kingdom ⤷  Try a Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1663978 C01663978/01 Switzerland ⤷  Try a Trial FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840 C01140840/01 Switzerland ⤷  Try a Trial FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840 PA 2006 008, C 1140840 Lithuania ⤷  Try a Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1663978 475 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.