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STIVARGA Drug Profile
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» See Plans and PricingWhen 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 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 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: | 277 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 99 |
| Clinical Trials: | 61 |
| 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 |
|---|---|
| Wake Forest University Health Sciences | Phase 2 |
| Centre Leon Berard | N/A |
| The First People's Hospital of Jingzhou | 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 |
| 2015-11-09 |
Pharmacology for STIVARGA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 2C9 Inhibitors |
Synonyms for STIVARGA
| 1255386-16-3 |
| 2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]-3-fluorophenoxy]-N-methyl- |
| 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-(trifluoromethy)phenyl]carbamoyl}amino)-3-fluorophenoxy]-1-methylpyridine-2-carboxamide |
| 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide |
| 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 |
| AK106990 |
| AKOS015951107 |
| AM81251 |
| AOB87754 |
| AS-16304 |
| AX8232295 |
| BAY 73-4506 |
| BAY 734506 |
| BAY-73-4506 |
| Bay-734506 |
| 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 |
| CS-0170 |
| D10138 |
| DB08896 |
| DTXSID60226441 |
| EX-A058 |
| Fluoro-Sorafenib |
| FNHKPVJBJVTLMP-UHFFFAOYSA-N |
| FT-0674338 |
| GTPL5891 |
| HMS3654K16 |
| HY-10331 |
| KS-00000Q4Q |
| MLS006010303 |
| NCGC00263138-01 |
| NCGC00263138-13 |
| Q3891664 |
| QCR-85 |
| R0142 |
| Regorafenib |
| Regorafenib - BAY 73-4506 |
| Regorafenib (BAY 73-4506) |
| Regorafenib (BAY73-4506 Fluoro-Sorafenib) |
| Regorafenib (USAN/INN) |
| Regorafenib [USAN:INN] |
| Regorafenib crystalline form I |
| 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 |
| 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 | |||
| >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 |
|---|---|---|
| Russian Federation | 2007148266 | Start Trial |
| European Patent Office | 1690853 | Start Trial |
| Colombia | 5170439 | Start Trial |
| Costa Rica | 10663 | Start Trial |
| Spain | 2377847 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for STIVARGA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1663978 | SPC/GB13/076 | United Kingdom | Start Trial | PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTERED: UK EU/1/13/858/001 20130829; UK EU/1/13/858/002 20130829 |
| 1140840 | SPC 031/2006 | Ireland | Start Trial | SPC 031/2006: 20070528, EXPIRES: 20210718 |
| 1140840 | 122006000059 | Germany | Start Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 1140840 | SPC/GB07/004 | United Kingdom | Start Trial | PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721 |
| 1140840 | CA 2007 00002 | Denmark | Start Trial | PRODUCT NAME: SORAFENIB TOSYLAT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
