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SUTENT Drug Profile
» See Plans and Pricing
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 eighty patent family members in forty-two countries.
The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
US ANDA Litigation and Generic Entry Outlook for Sutent
Sutent was eligible for patent challenges on January 26, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 15, 2021. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for SUTENT
| International Patents: | 80 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 89 |
| Clinical Trials: | 155 |
| Patent Applications: | 3,958 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SUTENT |
| What excipients (inactive ingredients) are in SUTENT? | SUTENT excipients list |
| DailyMed Link: | SUTENT at DailyMed |
Generic Entry Opportunity Date for SUTENT
Generic Entry Date for SUTENT*:
Constraining patent/regulatory 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 |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Phase 3 |
| Roche Pharma AG | Phase 2 |
| Ulrik Lassen | Phase 2 |
Pharmacology for SUTENT
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
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 | |||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-003 | Jan 26, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cppi Cv | SUTENT | sunitinib malate | CAPSULE;ORAL | 021938-002 | Jan 26, 2006 | 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 |
| Brazil | PI0117360 | Start Trial |
| Netherlands | 300430 | Start Trial |
| Japan | 2003523340 | Start Trial |
| Luxembourg | 91657 | Start Trial |
| Austria | 331514 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0145689 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SUTENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1255752 | C200800007 | Spain | Start Trial | PRODUCT NAME: SUNITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/06/347/001-003; DATE OF AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/06/347/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20060719 |
| 1255752 | CA 2010 00004 | Denmark | Start Trial | PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT |
| 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 | 2008/004 | Ireland | Start Trial | PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE L-MALATE SALT; AUTHORISATION NO/DATE: IRELAND EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719 |
| 1255752 | PA2010002,C1255752 | Lithuania | Start Trial | PRODUCT NAME: TOCERANIBUM; REGISTRATION NO/DATE: EU/2/09/100/001, 2009 09 23 EU/2/09/100/002, 2009 09 23 EU/2/09/100/003 20090923 |
| 1255752 | SPC003/2010 | Ireland | Start Trial | SPC003/2010: 20100702, EXPIRES: 20240922 |
| 1255752 | 312 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
