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, 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.
Summary for sorafenib tosylate
International Patents: | 89 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 164 |
Patent Applications: | 8 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sorafenib tosylate |
DailyMed Link: | sorafenib tosylate at DailyMed |
Recent Clinical Trials for sorafenib tosylate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Maternal and Child Health Hospital of Foshan | Phase 2/Phase 3 |
Guangzhou First People's Hospital | Phase 2/Phase 3 |
Third Affiliated Hospital, Sun Yat-Sen University | Phase 2/Phase 3 |
Pharmacology for sorafenib tosylate
Drug Class | Kinase 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
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 |
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