You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Sorafenib tosylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has eighty-nine patent family members in thirty-nine countries.

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

Recent Clinical Trials for sorafenib tosylate

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

SponsorPhase
Maternal and Child Health Hospital of FoshanPhase 2/Phase 3
Guangzhou First People's HospitalPhase 2/Phase 3
Third Affiliated Hospital, Sun Yat-Sen UniversityPhase 2/Phase 3

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 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
Yabao Pharm SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209050-001 Nov 9, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 217095-001 Apr 12, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Dr Reddys SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 216073-001 Jun 7, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209567-001 Nov 12, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 207012-001 Sep 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sorafenib tosylate

Country Patent Number Title Estimated Expiration
Cuba 23821 COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UNA DIFENILUREA SUSTITUIDA CON OMEGA-CARBOXIARILO PARA EL TRATAMIENTO DEL CÁNCER ⤷  Try a Trial
Taiwan 200700093 Pharmaceutical composition for the treatment of cancer ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006094626 ⤷  Try a Trial
Singapore 155996 THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE ⤷  Try a Trial
Peru 20061345 COMPOSICION FARMACEUTICA QUE COMPRENDE SORAFENIB ⤷  Try a Trial
South Korea 20100061869 THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE ⤷  Try a Trial
Ukraine 93673 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ СОДЕРЖИТ ОМЕГА-КАРБОКСИАРИЛЗАМЕЩЕННУЮ ДИФЕНИЛМОЧЕВИНУ, ДЛЯ ЛЕЧЕНИЯ PAKA;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА МІСТИТЬ ОМЕГА-КАРБОКСІАРИЛЗАМІЩЕНУ ДИФЕНІЛСЕЧОВИНУ, ДЛЯ ЛІКУВАННЯ РАКУ (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sorafenib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 35/2006 Austria ⤷  Try a Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SZ 35/2006 Austria ⤷  Try a Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840 06C0034 France ⤷  Try a 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
1140840 PA2006008 Lithuania ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840 122006000059 Germany ⤷  Try a Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 PA2006008,C1140840 Lithuania ⤷  Try a 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

Make Better Decisions: Try a trial or see plans & pricing

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.