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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-seven 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.
US ANDA Litigation and Generic Entry Outlook for Stivarga
Stivarga was eligible for patent challenges on September 27th, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 8th, 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.
Summary for STIVARGA
| International Patents: | 277 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 98 |
| Clinical Trials: | 60 |
| Patent Applications: | 78 |
| 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
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 |
|---|---|
| Centre Leon Berard | N/A |
| The First People's Hospital of Jingzhou | Phase 1/Phase 2 |
| China Medical University, China | Phase 1/Phase 2 |
Recent Litigation for STIVARGA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Bayer Healthcare LLC v. Apotex, Inc. | 2018-09-21 |
| Bayer Healthcare LLC v. Apotex Inc. | 2016-12-16 |
| Bayer Healthcare LLC v. Apotex, Inc. | 2016-12-16 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Fustibal LLC | 2016-07-25 |
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 |
| ACN-036634 |
| AJ-56815 |
| AKOS015951107 |
| AM81251 |
| AOB87754 |
| AS-16304 |
| AX8232295 |
| BAY 73-4506 |
| BAY 73-4506; Stivarga |
| BAY 734506 |
| BAY-73-4506 |
| BAY-734506 monohydrate |
| BAY73-4506 |
| BAY73-4506 hydrochloride |
| BAY73-4506(Regorafenib)/ |
| BCP02105 |
| BCP9000384 |
| BCPP000352 |
| BDBM50363397 |
| BRD-K16730910-001-02-4 |
| C21H15ClF4N4O3 |
| cas:835621-07-3;Regorafenib hydrochloride |
| CHEBI:68647 |
| CHEMBL1946170 |
| CJ-13100 |
| CS-0170 |
| D10138 |
| DB08896 |
| DTXSID60226441 |
| EX-A058 |
| FNHKPVJBJVTLMP-UHFFFAOYSA-N |
| FT-0674338 |
| GTPL5891 |
| HMS3654K16 |
| HY-10331 |
| KB-80344 |
| KS-00000Q4Q |
| MLS006010303 |
| MolPort-009-679-472 |
| NCGC00263138-01 |
| NCGC00263138-13 |
| 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 |
| SB16819 |
| SC-28977 |
| SCHEMBL432230 |
| SMR004701370 |
| SR-01000941571 |
| SR-01000941571-1 |
| ST24023156 |
| Stivarga (TN) |
| SW218097-2 |
| SYN1169 |
| UNII-24T2A1DOYB |
| ZINC6745272 |
Paragraph IV (Patent) Challenges for STIVARGA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| STIVARGA | TABLET;ORAL | regorafenib | 203085 | 2016-09-27 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | STIVARGA | regorafenib | TABLET;ORAL | 203085-001 | Sep 27, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovakia | 9882001 | Start Trial |
| Croatia | P20010580 | Start Trial |
| Norway | 20055863 | Start Trial |
| Dominican Republic | P2016000285 | Start Trial |
| Australia | 2013200394 | Start Trial |
| South Korea | 101800041 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for STIVARGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663978 | 122013000086 | Germany | Start Trial | PRODUCT NAME: REGORAFENIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
| 1140840 | SZ 35/2006 | Austria | Start Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON |
| 1663978 | 475 | Finland | Start Trial | |
| 1663978 | 92300 | Luxembourg | Start Trial | PRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA) |
| 1663978 | CR 2013 00056 | Denmark | Start Trial | PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826 |
| 1663978 | CA 2013 00056 | Denmark | Start Trial | PRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
