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Sorafenib tosylate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for sorafenib tosylate?

Sorafenib tosylate is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and fifty-two patent family members in fifty-four countries.

There are ten drug master file entries for sorafenib tosylate. One supplier is listed for this compound.

Summary for Generic Name: sorafenib tosylate

Tradenames:1
Patents:8
Applicants:1
NDAs:1
Drug Master File Entries: see list10
Suppliers / Packagers: see list1
Bulk Api Vendors: see list72
Clinical Trials: see list368
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sorafenib tosylate at DailyMed

Pharmacology for Ingredient: sorafenib tosylate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYesYes► Subscribe► Subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYesYes8,618,141► Subscribe ► Subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYesYes► Subscribe► Subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYesYes8,841,330► Subscribe ► Subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYesYes7,897,623► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sorafenib tosylate

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
8,242,147Aryl ureas with angiogenisis inhibiting activity► Subscribe
7,528,255Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors► Subscribe
7,928,239Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas► Subscribe
7,838,541Aryl ureas with angiogenesis inhibiting activity► 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: sorafenib tosylate

Country Document Number Estimated Expiration
Jordan2373► Subscribe
World Intellectual Property Organization (WIPO)03068228► Subscribe
Norway2007002► Subscribe
Peru20422014► Subscribe
China1341098► 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: SORAFENIB TOSYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840/01Switzerland► SubscribeFORMER REPRESENTANTIVE: A. BRAUN, BRAUN, HERITIER, ESCHMANN AG PATENTANWAELTE, CH
280Luxembourg► Subscribe91280, EXPIRES: 20210720
C/GB07/004United Kingdom► SubscribeSPC/GB07/004: 20061227
5Finland► Subscribe
C0034France► SubscribePRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
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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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