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Last Updated: May 20, 2022

STIVARGA Drug Patent Profile


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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty 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.

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 six 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

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Drug patent expirations by year for STIVARGA
Drug Prices for STIVARGA

See drug prices for STIVARGA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
AmgenPhase 3
Helsinki University Central HospitalPhase 2
University of SydneyPhase 3

See all STIVARGA clinical trials

Pharmacology for STIVARGA
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 five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIVARGA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

.omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fluoro substituted omega-carboxyaryl diphenyl urea for the treatment and prevention of diseases and conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of cancers with acquired resistance to kit inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

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

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: See Plans and Pricing

Patent: 6395
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11240113
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012026117
Estimated Expiration: See Plans and Pricing

Canada

Patent: 96238
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002840
Estimated Expiration: See Plans and Pricing

China

Patent: 2947271
Estimated Expiration: See Plans and Pricing

Patent: 3980191
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30136
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120526
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150885
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 123
Estimated Expiration: See Plans and Pricing

Patent: 120147
Estimated Expiration: See Plans and Pricing

Patent: 140060
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 58448
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 012000268
Estimated Expiration: See Plans and Pricing

Patent: 016000285
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12012234
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58448
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1200280
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 00831
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26821
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2348
Estimated Expiration: See Plans and Pricing

Patent: 3119
Estimated Expiration: See Plans and Pricing

Japan

Patent: 34182
Estimated Expiration: See Plans and Pricing

Patent: 13523851
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 58
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2359
Estimated Expiration: See Plans and Pricing

Patent: 7066
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12011734
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 156
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2997
Estimated Expiration: See Plans and Pricing

Peru

Patent: 130181
Estimated Expiration: See Plans and Pricing

Patent: 160838
Estimated Expiration: See Plans and Pricing

Poland

Patent: 58448
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 58448
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 81585
Estimated Expiration: See Plans and Pricing

Patent: 12148386
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 219
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 4172
Estimated Expiration: See Plans and Pricing

Patent: 201501221U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 58448
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1800041
Estimated Expiration: See Plans and Pricing

Patent: 130061670
Estimated Expiration: See Plans and Pricing

Patent: 170129276
Estimated Expiration: See Plans and Pricing

Spain

Patent: 42610
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 75992
Estimated Expiration: See Plans and Pricing

Patent: 39951
Estimated Expiration: See Plans and Pricing

Patent: 1204356
Estimated Expiration: See Plans and Pricing

Patent: 1509415
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000492
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0613
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 290
Estimated Expiration: See Plans and Pricing

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
Austria 556713 See Plans and Pricing
Taiwan I539951 See Plans and Pricing
Japan 5505906 See Plans and Pricing
Czech Republic 299125 Difenylové mocoviny substituované omega-karboxyarylovou skupinou jako inhibitory rafkinázy, jejich použití a farmaceutické kompozice s jejich obsahem (Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors, their use and pharmaceutical compositions containing thereof) See Plans and Pricing
Poland 1663978 See Plans and Pricing
Norway 337326 See Plans and Pricing
Japan 5885012 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STIVARGA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 PA2006008,C1140840 Lithuania See Plans and Pricing PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1663978 CA 2013 00056 Denmark See Plans and Pricing PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1663978 C01663978/01 Switzerland See Plans and Pricing FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840 SPC 031/2006 Ireland See Plans and Pricing SPC 031/2006: 20070528, EXPIRES: 20210718
1140840 295 Finland See Plans and Pricing
1663978 CR 2013 00056 Denmark See Plans and Pricing PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1663978 56/2013 Austria See Plans and Pricing PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
McKinsey
Moodys
Dow

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.