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Last Updated: October 16, 2021

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SORAFENIB TOSYLATE - Generic Drug Details

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What are the generic drug sources for sorafenib tosylate and what is the scope of patent protection?

Sorafenib tosylate is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Mylan, and Teva Pharms Usa Inc, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has one hundred and two patent family members in thirty-nine countries.

There are thirteen drug master file entries for sorafenib tosylate. One supplier is listed for this compound.

Recent Clinical Trials for SORAFENIB TOSYLATE

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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
University of WashingtonPhase 1/Phase 2
Dana-Farber Cancer InstitutePhase 1

See all SORAFENIB TOSYLATE clinical trials

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

US Patents and Regulatory Information for SORAFENIB TOSYLATE

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 ⤷  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
Teva Pharms Usa Inc SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209567-001 Nov 12, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 207012-001 Sep 10, 2020 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  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 SORAFENIB TOSYLATE

International Patents for SORAFENIB TOSYLATE

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2006034797 ⤷  Free Forever Trial
Croatia P20100674 ⤷  Free Forever Trial
South Africa 200702510 ⤷  Free Forever Trial
Canada 2601955 ⤷  Free Forever Trial
Denmark 1797038 ⤷  Free Forever Trial
Japan 2013100302 ⤷  Free Forever Trial
Hong Kong 1209620 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for SORAFENIB TOSYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 PA2006008,C1140840 Lithuania ⤷  Free Forever Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
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 SPC/GB07/004 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 SZ 35/2006 Austria ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840 35/2006 Austria ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 CA 2007 00002 Denmark ⤷  Free Forever Trial PRODUCT NAME: SORAFENIB TOSYLAT
1140840 06C0034 France ⤷  Free Forever Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Baxter
Mallinckrodt
McKesson
McKinsey
Colorcon

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