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Last Updated: November 27, 2022

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, Dr Reddys, Mylan, and Teva Pharms Usa Inc, and is included in four 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 three patent family members in thirty-nine countries.

There are twelve drug master file entries for sorafenib tosylate. Three suppliers are listed for this compound.

Recent Clinical Trials for sorafenib tosylate

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

SponsorPhase
Southern Medical University, ChinaPhase 2/Phase 3
Jiangxi Province Children's HospitalPhase 2/Phase 3
The First Affiliated Hospital of Nanchang UniversityPhase 2/Phase 3

See all sorafenib tosylate clinical trials

Pharmacology for sorafenib tosylate
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors
Paragraph IV (Patent) Challenges for SORAFENIB TOSYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEXAVAR Tablets sorafenib tosylate 200 mg 021923 1 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
Mylan SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 207012-001 Sep 10, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa Inc SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209567-001 Nov 12, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 216073-001 Jun 7, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sorafenib tosylate

Country Patent Number Title Estimated Expiration
Ukraine 91520 ТЕРМОДИНАМІЧНО СТАБІЛЬНА ФОРМА ТОЗИЛАТУ[ТЕРМОДИНАМИЧЕСКИ СТАБИЛЬНАЯ ФОРМА ТОЗИЛАТА (THERMODYNAMICALLY STABLE FORM OF TOSYLATE) See Plans and Pricing
Taiwan 200700093 Pharmaceutical composition for the treatment of cancer See Plans and Pricing
New Zealand 561178 Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer See Plans and Pricing
South Africa 200702510 Thermodynamically stable form of bay 43-9006 tosylate See Plans and Pricing
Cyprus 1113598 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sorafenib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 122006000059 Germany See Plans and Pricing PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 35/2006 Austria See Plans and Pricing PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SPC/GB07/004 United Kingdom See Plans and Pricing PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 PA2006008,C1140840 Lithuania See Plans and Pricing PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SZ 35/2006 Austria See Plans and Pricing PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.