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Serving leading biopharmaceutical companies globally:

Accenture
Covington
Farmers Insurance
Fuji
QuintilesIMS
McKinsey
Healthtrust
Medtronic
Queensland Health
Colorcon

Generated: February 24, 2018

DrugPatentWatch Database Preview

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.

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
International Patents:227
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 80
Clinical Trials: 43
Patent Applications: 63
Drug Prices:see details
DailyMed Link:STIVARGA at DailyMed
Drug patent expirations by year for STIVARGA
Pharmacology for STIVARGA

US Patents and Regulatory Information for STIVARGA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare STIVARGA regorafenib TABLET;ORAL 203085-001 Sep 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for STIVARGA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 40 mg ➤ Subscribe 9/27/2016

Non-Orange Book US Patents for 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
7,528,255 Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors ➤ Try a Free Trial
8,124,630 .omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors ➤ Try a Free Trial
8,841,330 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors ➤ Try a Free Trial
8,748,622 Process 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 ➤ Try a Free Trial
7,897,623 .omega.-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors ➤ Try a Free Trial
7,928,239 Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for STIVARGA

Supplementary Protection Certificates for STIVARGA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0060 France ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB ET SES SELS; REGISTRATION NO/DATE: EU/1/13/858/001-002 20130826
5 Finland ➤ Try a Free Trial
C 031/2006 Ireland ➤ Try a Free Trial SPC 031/2006: 20070528, EXPIRES: 20210718
90050-1 Sweden ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB
C/GB07/004 United Kingdom ➤ Try a Free Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
2006008 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
0130034 00099 Estonia ➤ Try a Free Trial PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
1140840/01 Switzerland ➤ Try a Free Trial FORMER REPRESENTATIVE: BOHEST AG, CH
2006008,C1140840 Lithuania ➤ Try a Free Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
/2013 Austria ➤ Try a Free Trial PRODUCT NAME: REGORAFENIB UND SEINE SALZE; REGISTRATION NO/DATE: EU/1/13/858 (MITTEILUNG) 20130829
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Citi
Johnson and Johnson
Fish and Richardson
Cerilliant
Federal Trade Commission
Express Scripts
Medtronic
Harvard Business School

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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