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SUTENT Drug Profile
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» See Plans and PricingWhich 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. One supplier is 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 have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (sunitinib malate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for SUTENT
| International Patents: | 80 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 87 |
| Clinical Trials: | 154 |
| Patent Applications: | 8,279 |
| 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:
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 |
|---|---|
| Ulrik Lassen | Phase 2 |
| GlaxoSmithKline | Phase 2 |
| Roche Pharma AG | 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 | |||
| >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 |
|---|---|---|
| Slovakia | 287142 | Start Trial |
| China | 1439005 | Start Trial |
| Australia | 3977001 | Start Trial |
| Bulgaria | 65764 | Start Trial |
| Colombia | 5280092 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SUTENT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | CA 2008 00015 | Denmark | Start Trial | PRODUCT NAME: SUNITINIB EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HERUNDER L-MALEATSALTET |
| 1255752 | SPC/GB08/007 | United Kingdom | Start Trial | PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L-MALATE SALT.; REGISTERED: UK EU/1/06/347/001 20060724; UK EU/1/06/347/002 20060724; UK EU/1/06/347/003 20060724 |
| 1255752 | 312 | Finland | Start Trial | |
| 1255752 | CA 2010 00004 | Denmark | Start Trial | PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
