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Last Updated: October 26, 2021

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NEXAVAR Drug Patent Profile


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Which patents cover Nexavar, and when can generic versions of Nexavar launch?

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

This drug has one hundred and two patent family members in thirty-nine countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Nexavar

Nexavar was eligible for patent challenges on December 20, 2009.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for NEXAVAR
Drug Prices for NEXAVAR

See drug prices for NEXAVAR

Recent Clinical Trials for NEXAVAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mina Alpha LimitedPhase 2
China Medical University HospitalPhase 4
First Affiliated Hospital of Zhejiang UniversityPhase 3

See all NEXAVAR clinical trials

Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for NEXAVAR
Tradename Dosage Ingredient NDA Submissiondate
NEXAVAR TABLET;ORAL sorafenib tosylate 021923 2014-02-28

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NEXAVAR

Supplementary Protection Certificates for NEXAVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 122006000059 Germany ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SZ 35/2006 Austria ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840 PA2006008 Lithuania ⤷  Free Forever Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 CA 2007 00002 Denmark ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB TOSYLAT
1140840 295 Finland ⤷  Free Forever Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
Merck
Colorcon

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