DrugPatentWatch Database Preview
SUTENT Drug Profile
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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 seventy-three patent family members in thirty-nine countries.
The generic ingredient in SUTENT is sunitinib malate. There are six 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: | 130 |
| Clinical Trials: | 145 |
| Patent Applications: | 4,500 |
| 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 | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 |
Non-Orange Book US Patents for SUTENT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,572,924 | Pyrrole substituted 2-indolinone protein kinase inhibitors | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for SUTENT
Supplementary Protection Certificates for SUTENT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2008000002 | Germany | ➤ Sign Up | PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALATSALZES; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060719 |
| 2008002 | Lithuania | ➤ Sign Up | PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808 |
| C/GB08/007 | United Kingdom | ➤ Sign Up | PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L- MALATE SALT; REGISTRATION NO/DATE: EU/1/06/347/001 - 003 20060724 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
