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Regorafenib - Generic Drug Details

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

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.

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

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

Summary for Generic Name: regorafenib

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list71
Clinical Trials: see list50
Patent Applications: see list49
Drug Prices:see low prices
DailyMed Link:regorafenib at DailyMed

Pharmacology for Ingredient: regorafenib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes8,637,553► SubscribeYY ► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes7,351,834► SubscribeY ► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes8,680,124► Subscribe ► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► 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
8,841,330Omega-carboxyaryl substituted diphenyl ureas 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
7,528,255Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors► 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
MexicoPA03009649► Subscribe
Chile2004001834► Subscribe
Spain2297490► Subscribe
World Intellectual Property Organization (WIPO)2008089389► Subscribe
Spain2384160► 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
2006008,C1140840Lithuania► SubscribePRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
13/050Ireland► SubscribePRODUCT NAME: REGORAFENIB AND ITS SALTS; REGISTRATION NO/DATE: EU/1/13/858 20130826
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
300Luxembourg► SubscribePRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
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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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