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Serving leading biopharmaceutical companies globally:

Citi
Merck
US Department of Justice
Colorcon
Mallinckrodt
Federal Trade Commission
Johnson and Johnson
Novartis
Medtronic
Boehringer Ingelheim

Generated: February 20, 2018

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.
Drug patent expirations by year for SUTENT
Pharmacology for SUTENT
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 Submissiondate
➤ Subscribe Capsules 12.5 mg, 25 mg, 37.5 mg and 50 mg ➤ Subscribe 1/26/2010

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 ➤ Try a Free Trial
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
C/GB08/007 United Kingdom ➤ Try a Free Trial 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
C0002 France ➤ Try a Free Trial 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
657 Luxembourg ➤ Try a Free Trial 91657, EXPIRES: 20240923
C004/2008 Ireland ➤ Try a Free Trial SPC004/2008: 20081105, EXPIRES: 20210718
2008002 Lithuania ➤ Try a Free Trial PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
2008000002 Germany ➤ Try a Free Trial 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
C/GB10/008 United Kingdom ➤ Try a Free Trial 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
1255752/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006
C0003 France ➤ Try a Free Trial PRODUCT NAME: TOCERAMIB ET OPTIONELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET EN PARTICULIER LE PHOSPHATE DE TOCERANIB; REGISTRATION NO/DATE IN FRANCE: EU/2/09/100/001 DU 20090923; REGISTRATION NO/DATE AT EEC: EU/2/09/100/001 DU 20090923
2 Finland ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Colorcon
Dow
Chubb
Healthtrust
QuintilesIMS
Julphar
US Department of Justice
Express Scripts

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