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 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 |


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
Sponsor | Phase |
---|---|
Great Novel Therapeutics Biotech & Medicals Corporation | Phase 1/Phase 2 |
University of Miami | Phase 2 |
The First Affiliated Hospital of Dalian Medical University | Phase 1/Phase 2 |
Pharmacology for STIVARGA
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 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Dominican Republic | P2016000285 | PROCEDIMIENTO PARA LA PREPARACIÓN DE 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA-2-CARBOXAMIDA, SUS SALES Y SU MONOHIDRATO | ⤷ 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 |
Israel | 144030 | OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREAS, PHARMACEUTICAL COMPOSITIONS COMPRISING THEM AND THEIR USE FOR THE PREPARATION OF MEDICAMENTS FOR INHIBITING RAF KINASE | ⤷ Try a Trial |
European Patent Office | 1379507 | UREES HETEROARYLES CONTENANT DES HETERO-ATOMES D'AZOTE COMME INHIBITEURS DE KINASE P38 (HETEROARYL UREAS CONTAINING NITROGEN HETERO-ATOMS AS p38 KINASE INHIBITORS) | ⤷ Try a Trial |
Taiwan | 201204356 | Process | ⤷ Try a Trial |
South Korea | 20090061043 | 4-[4-({[4-CHLORO-3-(TRIFLUOROMETHYL)PHENYL)]CARBAMOYL}AMINO)-3-FLUOROPHENOXY]-N-METHYLPYRIDINE-2-CARBOXAMIDE MONOHYDRATE | ⤷ 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 | 122013000086 | Germany | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
1663978 | 1390050-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28 |
1663978 | C300620 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
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 |
1140840 | 295 | Finland | ⤷ Try a Trial | |
1140840 | PA2006008,C1140840 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |