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STIVARGA Drug Profile
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Which patents cover Stivarga, and what generic alternatives are available?
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 seventy 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.
Summary for STIVARGA
| International Patents: | 270 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 43 |
| Patent Applications: | 70 |
| Drug Prices: | Drug price information for STIVARGA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STIVARGA |
| DailyMed Link: | STIVARGA at DailyMed |
Generic Entry Opportunity 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.
Pharmacology for STIVARGA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 2C9 Inhibitors |
Synonyms for STIVARGA
| 2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]-3-fluorophenoxy]-N-methyl- |
| 24T2A1DOYB |
| 4-(4-(((4-chloro-3-(trifluoromethyl)phenyl)carbamoyl}amino)-3-fluorophenoxy)-N-methylpyridine-2-carboxamide |
| 4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)-N-methylpicolinamide |
| 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluoro-phenoxy]-N-methyl-pyridine-2-carboxamide |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carbox |
| 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]-3-fluorophenoxy]-N-methylpyridine-2-carboxamide |
| 4{4-[3-(4-chloro-3-trifluoromethylphenyl)-ureido]-3-fluorophenoxy}-pyridine-2-carboxylic acid methylamide |
| 4CA-1083 |
| 755037-03-7 |
| 835621-08-4 |
| A25020 |
| AB0008044 |
| AB01565826_02 |
| AB1008457 |
| ABP000611 |
| AC-25075 |
| AJ-56815 |
| AK106990 |
| AKOS015951107 |
| AM81251 |
| anhydrous regorafenib |
| AOB87754 |
| AS-16304 |
| AX8232295 |
| BAY 73-4506 |
| BAY 734506 |
| BAY-73-4506 |
| BAY-734506 monohydrate |
| BAY73-4506 |
| BAY73-4506 hydrochloride |
| BAY73-4506(Regorafenib)/ |
| BCP9000384 |
| BCPP000352 |
| BDBM50363397 |
| C21H15ClF4N4O3 |
| cas:835621-07-3;Regorafenib hydrochloride |
| CHEBI:68647 |
| CHEMBL1946170 |
| CJ-13100 |
| CS-0170 |
| D09GDD |
| D10138 |
| DB08896 |
| DTXSID60226441 |
| EX-A058 |
| FNHKPVJBJVTLMP-UHFFFAOYSA-N |
| FT-0674338 |
| GTPL5891 |
| HE070021 |
| HE386186 |
| HMS3654K16 |
| HY-10331 |
| KB-80344 |
| KS-00000Q4Q |
| MFCD16038047 |
| MLS006010303 |
| MolPort-009-679-472 |
| NCGC00263138-01 |
| QCR-85 |
| R0142 |
| Regorafenib |
| Regorafenib - BAY 73-4506 |
| Regorafenib (BAY 73-4506) |
| Regorafenib (BAY73-4506 Fluoro-Sorafenib) |
| Regorafenib (USAN/INN) |
| Regorafenib [USAN:INN] |
| Regorafenib, 755037-03-7 |
| Regorafenib,BAY 73-4506 |
| Regorafenib;1-(4-chloro-3-(trifluoromethyl)phenyl)-3-(2-fluoro-4-(2-(methylcarbamoyl)pyridin-4-yloxy)phenyl)urea |
| Regorafenib(BAY 73-4506) |
| RegorafenibBAY73-4506 |
| Regorafenibum |
| RL04875 |
| S-7780 |
| s1178 |
| SC-28977 |
| SCHEMBL432230 |
| SMR004701370 |
| SR-01000941571 |
| SR-01000941571-1 |
| ST24023156 |
| Stivarga (TN) |
| SYN1169 |
| UNII-24T2A1DOYB |
| ZINC6745272 |
US Patents and Regulatory Information for STIVARGA
| 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 | ➤ 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 | ➤ 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 | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for STIVARGA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 40 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for STIVARGA
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,748,622 | Process for the preparation of 4-{4[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluor- ophenoxy}-N-methylpyridine-2-carboxamide, its salts and monohydrate | ➤ Sign Up |
| 7,528,255 | Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors | ➤ Sign Up |
| 7,928,239 | Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas | ➤ Sign Up |
| 7,897,623 | .omega.-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors | ➤ Sign Up |
| 8,124,630 | .omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors | ➤ Sign Up |
| 8,841,330 | Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for STIVARGA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Argentina | 035310 | ➤ Sign Up |
| Japan | 2008542214 | ➤ Sign Up |
| Peru | 08382016 | ➤ Sign Up |
| South Korea | 20070020158 | ➤ Sign Up |
| Ukraine | 95984 | ➤ Sign Up |
| Japan | 2013523851 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for STIVARGA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 35/2006 | Austria | ➤ Sign Up | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON |
| 13/050 | Ireland | ➤ Sign Up | PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
| 5 | Finland | ➤ Sign Up | |
| 300 | Luxembourg | ➤ Sign Up | PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA) |
| 90050-1 | Sweden | ➤ Sign Up | PRODUCT NAME: REGORAFENIB |
| 2006008 | Lithuania | ➤ Sign Up | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
