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Sunitinib malate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for sunitinib malate?

Sunitinib malate is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sunitinib malate has sixty-seven patent family members in thirty-nine countries.

There are five drug master file entries for sunitinib malate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sunitinib malate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list118
Clinical Trials: see list205
Patent Applications: see list11,474
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sunitinib malate at DailyMed

Pharmacology for Ingredient: sunitinib malate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Tentative approvals for SUNITINIB MALATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE;ORALEQ 12.5MG BASE
► Subscribe► SubscribeCAPSULE;ORALEQ 25MG BASE
► Subscribe► SubscribeCAPSULE;ORALEQ 37.5MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes7,211,600► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo7,125,905► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo6,573,293► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo7,211,600► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-002Jan 26, 2006RXYesNo7,125,905► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sunitinib malate

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
7,572,924Pyrrole 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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International Patent Family for Ingredient: sunitinib malate

Country Document Number Estimated Expiration
Costa Rica20120009► Subscribe
Iceland2491► Subscribe
Germany60129794► Subscribe
Japan2004500363► Subscribe
CroatiaP20020751► 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 Certificates for Tradename: SUNITINIB MALATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010002,C1255752Lithuania► SubscribePRODUCT 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
8Finland► Subscribe
2010002Lithuania► SubscribePRODUCT 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
1255752/01Switzerland► SubscribePRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006
407Luxembourg► Subscribe91407, EXPIRES: 20210719
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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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