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
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Questions you can ask:
- What is the 5 year forecast for STIVARGA?
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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: | 82 |
| Patent Applications: | 2,277 |
| 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
*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 |
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 four US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of STIVARGA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatment of cancers with acquired resistance to kit inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenox- y]-N-methylpyridine-2-carboxamide monohydrate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: PROCEDIMIENTO PARA PREPARAR 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDIN-2-CARBOXAMIDA
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Australia
Patent: 11240113
Patent: 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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012026117
Patent: processo para preparação de 4-{4-[({[4-cloro-3-(triflúor-metil)fenil]amino}carbonil)amino]-3-flúor-fenóxi}-n-metil-piridina-2-carboxamida, seus sais e monohidrato
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 96238
Patent: PROCEDE DE PREPARATION DE 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)-PHENYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHENOXY}-N-METHYLPYRIDINE-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)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12002840
Patent: Procedimiento de preparacion del compuesto de fórmula (i) 4-(4-((((4-cloro-3-(trifluorometil)fenil)amino)carbonil)amino)-3-fluorofenoxi)-n-metilpiridina-2-carboxamida y sus sales a partir de 4-(4-amino-3-fluorofenoxi)-n-metilpiridina-2-carboxamida y 1-cloro-4-isocianato-2-(trifluorometil)benceno; y el compuesto de fórmula (i).
Estimated Expiration: ⤷ Sign Up
China
Patent: 2947271
Patent: 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
Estimated Expiration: ⤷ Sign Up
Patent: 3980191
Patent: 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
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 30136
Patent: Procedimiento para la preparación de 4-{4[({4-cloro-3-(trifluorometil) fenil]amino}carbonil)amino]-3-fluorofenoxi}-n-metilpiridina-2-carbocamida, sus sales y su monohidrato
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120526
Patent: PROCESO PARA LA PREPARACIÓN DE 4-{4[({[4-CLORO-3-(TRIFLUOROMETILO)-FENILO] AMINO} CARBONILO) AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINO-2-CARBOXAMIDA, SUS SALES Y MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0150885
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 123
Patent: PROCEDIMIENTO PARA LA PREPARACIÓN DE 4-{ 4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENIXI}-N-METILPIRIDINA-2-CARBOXAMIDA Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Patent: 120147
Patent: PROCEDIMIENTO PARA LA PREPARACIÓN DE 4-{ 4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENIXI}-N-METILPIRIDINA-2-CARBOXAMIDA Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Patent: 140060
Patent: 4-{4-[({[ 4- CLORO-3-( TRIFLUOROMETIL) FENIL] AMINO} CARBONIL) AMINO]-3- FLUOROFENOXI}-N-METILPIRIDINA-2- CARBOXAMIDA Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 58448
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 012000268
Patent: PROCEDIMIENTO PARA LA PREPARACION DE 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL) FENIL]ANIMO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA-2-CARBOXAMIDA, SUS SALES Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Patent: 016000285
Patent: 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
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 12012234
Patent: PROCEDIMIENTO
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 58448
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 1200280
Patent: PROCEDIMIENTO
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 00831
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 26821
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2348
Patent: תהליך להכנת 4-{4-[({[4--כלורו-3-(טריפלואורומתיל)-פניל]אמינו}קרבוניל)אמינו]-3-פלואורופנוקסי}-n-מתילפירידין-2-קרבוקסאמיד, מלחיו ומונוהידראט שלו (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)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Japan
Patent: 34182
Estimated Expiration: ⤷ Sign Up
Patent: 13523851
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 58
Patent: عملية تحضير 4- {4 - [({[4-كلورو-3- (ترايفلوروميثيل) -فينيل] أمينو} الكربونيل)أمينو]-3-فلوروفينوكسي}- } -N-ميثلبريدين-2-كربوكساميد، وملح ومونوهيدرات منه (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)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2359
Patent: 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
Estimated Expiration: ⤷ Sign Up
Patent: 7066
Patent: PROCESS FOR THE PREPARATION OF 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)-PHENYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHENOXY}-N-METHYLPRIDINE-2-CARBOXAMIDE, ITS SALTS AND MONOHYDRATE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12011734
Patent: PROCEDIMIENTO PARA LA PREPARACION DE 4-{4-[({[4-CLORO-3-(TRIFLUORO METIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA -2-CARBOXAMIDA, SUSU SALES Y SU MONOHIDRATO. (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.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 156
Patent: PROCÉDÉDEPRÉPARATIONDE 4-{4-[({[4-CHLORO-3-(TRIFLUOROMÉTHYL)-PHÉNYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHÉNOXY}-N-ÉTHYLPYRIDINE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2997
Patent: 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
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 130181
Patent: PROCEDIMIENTO PARA LA PREPARACION DE 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA-2-CARBOXAMIDA, SUS SALES Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Patent: 160838
Patent: PROCEDIMIENTO PARA LA PREPARACION DE 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}-N-METILPIRIDINA-2-CARBOXAMIDA, SUS SALES Y SU MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 58448
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 58448
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 81585
Patent: СПОСОБ ПОЛУЧЕНИЯ 4-{4-[({[4-ХЛОР-3-(ТРИФТОРМЕТИЛ) ФЕНИЛ] АМИНО}-КАРБОНИЛ) АМИНО]-3-ФТОРФЕНОКСИ}-N-МЕТИЛПИРИДИН-2-КАРБОКСАМИДА, ЕГО СОЛЕЙ И МОНОГИДРАТА (METHOD OF PRODUCING 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL) PHENYL] AMINO} -CARBONYL) AMINO]-3-FLUOROPHENOXY}-N-METHYLPYRIDINE-2-CARBOXAMIDE, SALTS AND MONOHYDRATE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 12148386
Patent: СПОСОБ ПОЛУЧЕНИЯ 4-{4-[({[4-ХЛОР-3-(ТРИФТОРМЕТИЛ) ФЕНИЛ] АМИНО}-КАРБОНИЛ) АМИНО]-3-ФТОРФЕНОКСИ}-N-МЕТИЛПИРИДИН-2-КАРБОКСАМИДА, ЕГО СОЛЕЙ И МОНОГИДРАТА
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 219
Patent: PROCES ZA PRIPREMU 4-{4-[({[4-HLORO-3-(TRIFLUOROMETIL)-FENIL]AMINO}KARBONIL)AMINO]-3-FLUOROFENOKSI}-N-METILPIRIDIN-2-KARBOKSAMIDA, NJEGOVIH SOLI I NJEGOVOG MONOHIDRATA (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)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 4172
Patent: 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
Estimated Expiration: ⤷ Sign Up
Patent: 201501221U
Patent: 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
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 58448
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1800041
Estimated Expiration: ⤷ Sign Up
Patent: 130061670
Patent: 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
Estimated Expiration: ⤷ Sign Up
Patent: 170129276
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 42610
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 75992
Estimated Expiration: ⤷ Sign Up
Patent: 39951
Estimated Expiration: ⤷ Sign Up
Patent: 1204356
Patent: Process
Estimated Expiration: ⤷ Sign Up
Patent: 1509415
Patent: 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
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 12000492
Patent: 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
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 0613
Patent: СПОСІБ ОДЕРЖАННЯ 4-{4-[({[4-ХЛОР-3-(ТРИФТОРМЕТИЛ)ФЕНІЛ]АМІНО}КАРБОНІЛ)АМІНО]-3-ФТОРФЕНОКСИ}-N-МЕТИЛПІРИДИН-2-КАРБОКСАМІДУ, ЙОГО СОЛЕЙ І МОНОГІДРАТУ (PROCESS FOR PREPARING 4-{4-[({[4-CHLORO-3-(TRIFLUOROMETHYL)-PHENYL]AMINO}CARBONYL)AMINO]-3-FLUOROPHENOXY}-N-METHYLPYRIDINE-2-CARBOXARNIDE, ITS SALTS AND MONOHYDRATE)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 290
Patent: PROCEDIMIENTO PARA PREPARAR 4-{4-[({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}N-METILPIRIDIN-2-CARBOXAMIDA, SUS SALES Y MONOHIDRATO
Estimated Expiration: ⤷ Sign Up
Patent: 590
Patent: PROCEDIMIENTO PARA PREPARAR 4-{4-[({[4-CLORO-3- (TRIFLUOROMETIL)FENIL]AMINO}CARBONIL)AMINO]-3-FLUOROFENOXI}N- METILPIRIDIN-2-CARBOXAMIDA, MONOHIDRATO Y COMPOSICIONES QUE LO COMPRENDEN
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Israel | 144144 | ⤷ Sign Up | |
| Russian Federation | 2009117388 | МОНОГИДРАТ 4-[4-({[4-ХЛОР-3-(ТРИФТОРМЕТИЛ)ФЕНИЛ]КАРБАМОИЛ})АМИНО)-3-ФТОРФЕНОКСИ]-N-МЕТИЛПИРИДИН-2-КАРБОКСАМИДА | ⤷ Sign Up |
| Croatia | P20010580 | OMEGA-KARBOKSIARIL SUPSTITUIRANE DIFENILNE UREE KAO INHIBITORI RAF KINAZ (OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS) | ⤷ Sign Up |
| South Korea | 101139557 | ⤷ Sign Up | |
| China | 100522934 | ⤷ Sign Up | |
| Mexico | 2007014726 | TRATAMIENTO COMBINADO QUE COMPRENDE UN COMPUESTO DIARILUREA Y UNA PI3, AKT CINASA O INHIBIDORES MTOR (RAPAMICINA) PARA TRATAMIENTO DE CANCER. (COMBINATION THERAPY COMPRISING A DIARYL UREA COMPOUND AND A PI3, AKT KINASE OR MTOR INHIBITORS (RAPAMYCINS) FOR CANCER TREATMENT.) | ⤷ Sign Up |
| Chile | 2007002930 | UN COMPUESTO 4-[4-({[4-CLORO-3-(TRIFLUOROMETIL)FENIL]CARBAMOIL}AMINO)-3-FLUOROFENOXI]-N-METILPIRIDIN-2-CARBOXAMIDA MONOHIDRATADO; PROCESO DE PREPARACION; COMPOSICION Y COMBINACION FARMACEUTICA; Y USO PARA EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATI | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STIVARGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663978 | 475 | Finland | ⤷ Sign Up | |
| 1663978 | 56/2013 | Austria | ⤷ Sign Up | PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829 |
| 1140840 | PA2006008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 1140840 | 300242 | Netherlands | ⤷ Sign Up | |
| 1663978 | CA 2013 00056 | Denmark | ⤷ Sign Up | PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826 |
| 1140840 | SPC 031/2006 | Ireland | ⤷ Sign Up | SPC 031/2006: 20070528, EXPIRES: 20210718 |
| 1140840 | 06C0034 | France | ⤷ Sign Up | PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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