DrugPatentWatch Database Preview
STIVARGA Drug Profile
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 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: | 85 |
| Clinical Trials: | 49 |
| 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 | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for STIVARGA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 40 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for STIVARGA
Supplementary Protection Certificates for STIVARGA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 13/050 | Ireland | ➤ Sign Up | PRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826 |
| 90050-1 | Sweden | ➤ Sign Up | PRODUCT NAME: REGORAFENIB |
| 5 | Finland | ➤ Sign Up | |
| 0242 | Netherlands | ➤ Sign Up | |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
