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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Teva
Fish and Richardson
McKinsey
Citi
McKesson
Johnson and Johnson
Julphar
Harvard Business School
AstraZeneca

Generated: December 14, 2017

DrugPatentWatch Database Preview

Regorafenib - Generic Drug Details

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What are the generic drug sources for regorafenib and what is the scope of regorafenib patent protection?

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

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

There are two drug master file entries for regorafenib. One supplier is listed for this compound.

Pharmacology for regorafenib

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► SubscribeY► 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► 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► SubscribeYY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: regorafenib

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 Ingredient: regorafenib

Country Document Number Estimated Expiration
Chile2012002840► Subscribe
New Zealand602997► Subscribe
New Zealand580384► Subscribe
Denmark1663978► Subscribe
Denmark1140840► Subscribe
Ukraine110613► Subscribe
Ukraine84156► Subscribe
Germany122006000059► Subscribe
South Korea20130061670► Subscribe
Spain2255971► 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: REGORAFENIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00620Netherlands► SubscribePRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
9 13-2013Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/13/858, 20130826
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)
90050-1Sweden► SubscribePRODUCT NAME: REGORAFENIB
0242Netherlands► 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
2013 00056Denmark► SubscribePRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
1140840/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
/2013Austria► SubscribePRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
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Serving leading biopharmaceutical companies globally:

AstraZeneca
US Army
Merck
Argus Health
Queensland Health
McKinsey
Julphar
Farmers Insurance
Fish and Richardson
Federal Trade Commission

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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