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NEXAVAR Drug Profile

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Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NEXAVAR is sorafenib tosylate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

Summary for Tradename: NEXAVAR

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: NEXAVAR

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYes8,618,141► subscribe ► subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYes7,351,834► subscribeY ► subscribe
Bayer Hlthcare
NEXAVAR
sorafenib tosylate
TABLET;ORAL021923-001Dec 20, 2005RXYes8,841,330► subscribe ► subscribe
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Paragraph IV activity for: NEXAVAR

Drugname Dosage Strength RLD Submissiondate
sorafenib tosylateTablets200 mgNexavar2/28/2014

Non-Orange Book Patents for Tradename: NEXAVAR

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
7,528,255Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors► subscribe
7,838,541Aryl ureas with angiogenesis inhibiting activity► subscribe
8,242,147Aryl ureas with angiogenisis 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 Tradename: NEXAVAR

Country Document Number Estimated Expiration
Japan2007302687► subscribe
Norway2007002► subscribe
BrazilPI0007487► 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: NEXAVAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
280Luxembourg► subscribe91280, EXPIRES: 20210720
5Finland► subscribe
2006008,C1140840Lithuania► subscribePRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 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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