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Last Updated: March 8, 2021

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Sorafenib tosylate - Generic Drug Details

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What are the generic sources for sorafenib tosylate and what is the scope of freedom to operate?

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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has two hundred and fifteen patent family members in fifty-six 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
Memorial Sloan Kettering Cancer CenterPhase 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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Usa Inc SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209567-001 Nov 12, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Mylan SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 207012-001 Sep 10, 2020 DISCN No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005   Start Trial   Start Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for sorafenib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 PA 2006 008, C 1140840 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SPC 031/2006 Ireland   Start Trial SPC 031/2006: 20070528, EXPIRES: 20210718
1140840 CA 2007 00002 Denmark   Start Trial PRODUCT NAME: SORAFENIB TOSYLAT
1140840 PA2006008,C1140840 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SZ 35/2006 Austria   Start Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840 C01140840/01 Switzerland   Start Trial FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840 PA2006008 Lithuania   Start Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Mallinckrodt
Colorcon
McKesson

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