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
Summary for STIVARGA
International Patents: | 280 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 76 |
Patent Applications: | 3,276 |
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 |


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
Sponsor | Phase |
---|---|
Amgen | Phase 3 |
Helsinki University Central Hospital | Phase 2 |
University of Sydney | Phase 3 |
Pharmacology for STIVARGA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 2C9 Inhibitors Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |