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STIVARGA Drug Profile

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

This drug has two hundred and six patent family members in fifty-eight 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 Tradename: STIVARGA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: STIVARGA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYes8,680,124► subscribe ► subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYes► subscribe► subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYes8,637,553► subscribeYY ► subscribe
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Paragraph IV activity 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
8,841,330Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors► subscribe
8,124,630.omega.-carboxyaryl substituted diphenyl ureas as raf 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
New Zealand556598► subscribe
Poland215029► subscribe
TaiwanI539951► 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
2013 00056Denmark► subscribePRODUCT NAME: REGORAFENIB OG SALTE DERAF; REG. NO/DATE: EU/1/13/858 20130826
9 13-2013Slovakia► subscribePRODUCT NAME: REGORAFENIB; REGISTRATION NO/DATE: EU/1/13/858 20130826
1663978/01Switzerland► subscribePRODUCT NAME: REGORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62808 27.02.2013
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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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