DrugPatentWatch Database Preview
SUTENT Drug Profile
When do Sutent patents expire, 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 eighty patent family members in forty-one countries.
The generic ingredient in SUTENT is sunitinib malate. There are eight 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: | 80 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 153 |
| Patent Applications: | 6,247 |
| 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
Generic Entry Date for SUTENT*:
Constraining patent/regulatory exclusivity:
PEDIATRIC EXCLUSIVITY NDA:
Dosage:
CAPSULE;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 SUTENT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Milton S. Hershey Medical Center | Phase 1 |
| Eli Lilly and Company | Phase 1 |
| Deciphera Pharmaceuticals LLC | Phase 3 |
Recent Litigation for SUTENT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Mylan Inc. | 2010-06-16 |
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-dihydroindol-3-ylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic Acid (2-diethylaminoethyl)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 |
| AKOS015908193 |
| AKOS025312424 |
| AM20090630 |
| AN-9681 |
| AOB87111 |
| API0024677 |
| AX8033294 |
| BCPP000057 |
| BDBM4814 |
| C22H27FN4O2 |
| CF-876 |
| CHEBI:38940 |
| CHEBI:91430 |
| CHEMBL535 |
| CS-1670 |
| D08552 |
| DB01268 |
| EN002687 |
| EX-A553 |
| FT-0083556 |
| GTPL5713 |
| HSDB 7932 |
| HY-10255A |
| I01-1229 |
| J90060 |
| K00588a |
| KB-80777 |
| KS-5022 |
| LS-187023 |
| LS-187648 |
| MolPort-006-167-758 |
| N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3- |
| N-(2-(Diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide |
| 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 |
| Q572 |
| QCR-67 |
| s7781 |
| SC-47294 |
| SCHEMBL8081 |
| SR-00000000005 |
| SR-00000000005-2 |
| ST2413814 |
| SU 11248 |
| Su-011248 |
| SU-11248 |
| SU11248 |
| Sunitinib |
| Sunitinib (free base) |
| Sunitinib (INN) |
| Sunitinib [INN:BAN] |
| Sunitinib Base |
| Sunitinib malate |
| sunitinibum |
| Sutent (free base) |
| 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 |
Paragraph IV (Patent) Challenges for SUTENT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SUTENT | CAPSULE;ORAL | sunitinib malate | 021938 | 2010-01-26 |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-001 | Jan 26, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-004 | Mar 31, 2009 | RX | Yes | No | 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 SUTENT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1255752 | Start Trial |
| Eurasian Patent Organization | 200200862 | Start Trial |
| Poland | 211834 | Start Trial |
| New Zealand | 519697 | Start Trial |
| Bulgaria | 107078 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SUTENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1255752 | 5/2008 | Austria | Start Trial | PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719 |
| 1255752 | C 2008 002 | Romania | Start Trial | PRODUCT NAME: N-[2-(DIETILAMINO)ETIL]-5-[(Z)-(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL]-2,4-DIMETIL-1H-PIROL-3-CAROXAMIDA - SUNITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC,INCLUSIV A SARII L-MALAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/06/347/001, RO EU/1/06/347/002, RO EU/1/06/347/003; DATE OF NATIONAL AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003; DATE OF FIRST AUTHORISATION IN EEA: 20060719 |
| 1255752 | SPC004/2008 | Ireland | Start Trial | SPC004/2008: 20081105, EXPIRES: 20210718 |
| 1255752 | 2010C/009 | Belgium | Start Trial | PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923 |
| 1255752 | 312 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
