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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
Cipla
Chinese Patent Office
Novartis
Dow
Accenture
Baxter
McKesson
AstraZeneca

Generated: January 19, 2018

DrugPatentWatch Database Preview

NEXAVAR Drug Profile

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When do Nexavar patents expire, and what generic alternatives are available?

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

This drug has two hundred and eleven patent family members in fifty-six countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Drug patent expirations by year for NEXAVAR
Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for NEXAVAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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 NEXAVAR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 200 mg ➤ Subscribe 2/28/2014

Non-Orange Book US Patents for NEXAVAR

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 ➤ Subscribe
8,242,147 Aryl ureas with angiogenisis inhibiting activity ➤ Subscribe
7,928,239 Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas ➤ Subscribe
7,838,541 Aryl ureas with angiogenesis inhibiting activity ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for NEXAVAR

Supplementary Protection Certificates for NEXAVAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
35/2006 Austria ➤ Subscribe PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
C0034 France ➤ Subscribe PRODUCT 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
2006008 Lithuania ➤ Subscribe PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
C 031/2006 Ireland ➤ Subscribe SPC 031/2006: 20070528, EXPIRES: 20210718
2007 00002 Denmark ➤ Subscribe PRODUCT NAME: SORAFENIB TOSYLAT
1140840/01 Switzerland ➤ Subscribe FORMER REPRESENTANTIVE: A. BRAUN, BRAUN, HERITIER, ESCHMANN AG PATENTANWAELTE, CH
2006000059 Germany ➤ Subscribe PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
5 Finland ➤ Subscribe
2006 008, C 1140840 Lithuania ➤ Subscribe PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
280 Luxembourg ➤ Subscribe 91280, EXPIRES: 20210720
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Accenture
Teva
Cipla
McKinsey
Farmers Insurance
Merck
Cantor Fitzgerald
UBS

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