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Generated: September 20, 2017
What is the patent landscape for Sutent, and what generic Sutent 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.| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 110 |
| Clinical Trials: see list | 144 |
| Patent Applications: see list | 5,474 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | SUTENT at DailyMed |
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sunitinib malate | Capsules | 12.5 mg, 25 mg, 37.5 mg and 50 mg | Sutent | 1/26/2010 |
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 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0145689 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 325532 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1050642 | ► Subscribe | |||||||||||||||||||||||||||
| Colombia | 5280092 | ► Subscribe | |||||||||||||||||||||||||||
| Ukraine | 73976 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1255752 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | 0108394 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I306860 | ► Subscribe | |||||||||||||||||||||||||||
| Croatia | P20020751 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60129794 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB10/008 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 657 | Luxembourg | ► Subscribe | 91657, EXPIRES: 20240923 | ||||||||||||||||||||||||||
| 1255752/01 | Switzerland | ► Subscribe | PRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006 | ||||||||||||||||||||||||||
| 2010002 | Lithuania | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 2010002,C1255752 | Lithuania | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 1255752/02 | Switzerland | ► Subscribe | PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010 | ||||||||||||||||||||||||||
| C0003 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C004/2008 | Ireland | ► Subscribe | SPC004/2008: 20081105, EXPIRES: 20210718 | ||||||||||||||||||||||||||
| 2008002 | Lithuania | ► Subscribe | PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808 | ||||||||||||||||||||||||||
| 2 | Finland | ► Subscribe | |||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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