DrugPatentWatch Database Preview
SUTENT Drug Profile
Which patents cover Sutent, and what generic alternatives are available?
Sutent is a drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-three patent family members in thirty-nine countries.
The generic ingredient in SUTENT is sunitinib malate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for SUTENT
| International Patents: | 73 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 82 |
| Clinical Trials: | 149 |
| Patent Applications: | 4,511 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUTENT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SUTENT |
| DailyMed Link: | SUTENT at DailyMed |
Generic Entry Opportunity Date for SUTENT
*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 SUTENT
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for SUTENT
| (Z)-N-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-p |
| (Z)-N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| 1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl- |
| 1H-Pyrrole-3-carboxamide, N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl- |
| 1H-Pyrrole-3-carboxamide,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl- |
| 326914-13-0 |
| 341031-54-7 |
| 342641-94-5 |
| 5-(5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-ethyl)-amide |
| 5-(5-FLUORO-2-OXO-1,2-DIHYDRO-INDOL-3-YLIDENEMETHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXYLIC ACID (2-DIETHYLAMINO-ETHYL)-AMIDE |
| 5-[5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylamino-ethyl)-amide |
| 5-[5-fluoro-2-oxo-1,2-dihydro-indol-(3Z)-ylidenemethyl]-2,4-dimethyl-1H-pyrrole-3-carboxylic acid(2-diethylamino-ethyl)-amide |
| 557795-19-4 |
| 95S194 |
| AB0017673 |
| AB01273976_04 |
| AB01273976-01 |
| AB01273976-02 |
| AC1NS62J |
| AJ-47545 |
| AK-25799 |
| AK-98158 |
| AKOS015908193 |
| AKOS025312424 |
| AM20090630 |
| AN-9681 |
| AOB87111 |
| API0024677 |
| AX8033294 |
| BCPP000057 |
| BDBM4814 |
| C22H27FN4O2 |
| CF-876 |
| CHEBI:38940 |
| CHEBI:91430 |
| CHEMBL535 |
| CS-1670 |
| D08552 |
| D0R0MW |
| DB01268 |
| EN002687 |
| EX-A553 |
| FT-0083556 |
| GTPL5713 |
| HE352691 |
| HSDB 7932 |
| HY-10255A |
| I01-1229 |
| J90060 |
| K00588a |
| KB-80777 |
| KS-5022 |
| LS-187023 |
| LS-187648 |
| MFCD09260778 |
| MFCD09743439 |
| MolPort-006-167-758 |
| N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3- |
| N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1 pound not2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2 pound not4-dimethyl-1H-pyrrole-3-carboxamide |
| N-(2-diethylaminoethyl)-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[2-(Diethylamino)ethyl]-5-(2-oxo-5-fluoroindoline-3-ylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[2-(diethylamino)ethyl]-5-[(5-fluoro-2-oxo-2,3-dihydro-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| n-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide |
| N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-indolin-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[2-(diethylamino)ethyl]-5-{[(3Z)-5-fluoro-2-oxo-2,3-dihydro-1H-indol-3-ylidene]methyl}-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| N-[5-(Trifluoromethyl)-2-pyridinyl]-trans-4-[[(1,1-dimethylethyl)sulfonyl]amino]cyclohexane-1-carboxamide |
| NCGC00164631-02 |
| NCGC00164631-04 |
| NSC-750690 |
| NSC750690 |
| PDGF TK antagonist |
| Q572 |
| QCR-67 |
| s7781 |
| SC-47294 |
| SCHEMBL8081 |
| SR-00000000005 |
| SR-00000000005-2 |
| ST2413814 |
| SU 11248 |
| SU-010398 |
| Su-011248 |
| SU-11248 |
| SU-11248J |
| SU11248 |
| Sunitanib |
| Sunitinib |
| Sunitinib (free base) |
| Sunitinib (INN) |
| Sunitinib (Pan-TK inhibitor) |
| Sunitinib [INN:BAN] |
| Sunitinib Base |
| Sunitinib malate |
| Sunitinib, Free base |
| sunitinibum |
| Sutent (free base) |
| Sutent (TN) |
| Sutent, Sunitinib, SU11248 |
| UNII-V99T50803M |
| V99T50803M |
| W-2596 |
| WINHZLLDWRZWRT-ATVHPVEESA-N |
| ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| yrrole-3-carboxamide |
| Z2568722545 |
| ZINC3964325 |
US Patents and Regulatory Information for SUTENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-001 | Jan 26, 2006 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-001 | Jan 26, 2006 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | 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 SUTENT
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 12.5 mg, 25 mg, 37.5 mg and 50 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for SUTENT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1255536 | ➤ Sign Up |
| Bulgaria | 65764 | ➤ Sign Up |
| Canada | 2395461 | ➤ Sign Up |
| Eurasian Patent Organization | 200200862 | ➤ Sign Up |
| Netherlands | 300430 | ➤ Sign Up |
| New Zealand | 520640 | ➤ Sign Up |
| Iceland | 2491 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SUTENT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0002 | France | ➤ Sign Up | PRODUCT NAME: SUNITINIB ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUES ACCEPTABLES ET NOTAMMENT LE MALATE DE SUNITINIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/347/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/347/001 DU 20060719 |
| 2008002 | Lithuania | ➤ Sign Up | PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808 |
| 1255752/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006 |
| 0332 | Netherlands | ➤ Sign Up | |
| C003/2010 | Ireland | ➤ Sign Up | SPC003/2010: 20100702, EXPIRES: 20240922 |
| 657 | Luxembourg | ➤ Sign Up | 91657, EXPIRES: 20240923 |
| C/GB10/008 | United Kingdom | ➤ Sign Up | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/008 GRANTED TO SUGEN INC. AND PHARMACIA AND UPJOHN COMPANY LLC IN RESPECT OF THE PRODUCT TOCERANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE PHOSPHATE SALT.?, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6380 DATED 31 AUGUST 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 24 SEPTEMBER 2024 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
