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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Healthtrust
McKesson
Covington
Fuji
Queensland Health
US Army
Baxter
Moodys

Generated: December 11, 2017

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STIVARGA Drug Profile

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Which patents cover Stivarga, and what generic alternatives are available?

Stivarga is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-seven patent family members in fifty-eight countries and twenty-five supplementary protection certificates in fourteen countries.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Summary for STIVARGA

Drug patent expirations by year for STIVARGA

Pharmacology for STIVARGA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareSTIVARGAregorafenibTABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for STIVARGA

Drugname Dosage Strength RLD Submissiondate
regorafenibTablets40 mgStivarga9/27/2016

Non-Orange Book Patents for Tradename: STIVARGA

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
8,748,622Process for the preparation of 4-{4[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]-3-fluor- ophenoxy}-N-methylpyridine-2-carboxamide, its salts and monohydrate► Subscribe
8,124,630.omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors► Subscribe
8,841,330Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors► Subscribe
7,928,239Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas► Subscribe
7,897,623.omega.-carboxyl aryl substituted diphenyl ureas as p38 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 Tradename: STIVARGA

Country Document Number Estimated Expiration
South Korea20130061670► Subscribe
China102947271► Subscribe
New Zealand556598► Subscribe
Japan2010516693► Subscribe
Malaysia142799► Subscribe
Spain2297490► Subscribe
Austria520663► Subscribe
Russian Federation2581585► Subscribe
Morocco27946► Subscribe
Denmark1140840► 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: STIVARGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90050-1Sweden► SubscribePRODUCT NAME: REGORAFENIB
9 13-2013Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
280Luxembourg► Subscribe91280, EXPIRES: 20210720
5Finland► Subscribe
5Finland► Subscribe
13/050Ireland► SubscribePRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
300Luxembourg► SubscribePRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
C0060France► SubscribePRODUCT NAME: REGORAFENIB ET SES SELS; REGISTRATION NO/DATE: EU/1/13/858/001-002 20130826
2013 00056Denmark► SubscribePRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
2006008,C1140840Lithuania► SubscribePRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
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Serving leading biopharmaceutical companies globally:

Baxter
Chubb
Accenture
Express Scripts
US Army
Covington
Farmers Insurance
Julphar
AstraZeneca
Johnson and Johnson

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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