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. Eight 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: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 164 |
Patent Applications: | 8 |
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 |
---|---|
First Affiliated Hospital of Shantou University Medical College | Phase 2/Phase 3 |
The First Affiliated Hospital of Guangzhou Medical University | Phase 2/Phase 3 |
Maternal and Child Health Hospital of Foshan | Phase 2/Phase 3 |
Pharmacology for sorafenib tosylate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for sorafenib tosylate
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 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sorafenib tosylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Guatemala | 200600096 | COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER | ⤷ Sign Up |
Norway | 344272 | ⤷ Sign Up | |
China | 101132779 | Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer | ⤷ Sign Up |
European Patent Office | 1797038 | FORME THERMODYNAMIQUEMENT STABLE DE TOSYLATE DE BAY 43-9006 (THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE) | ⤷ Sign Up |
Norway | 343834 | ⤷ Sign Up | |
Peru | 20061345 | COMPOSICION FARMACEUTICA QUE COMPRENDE SORAFENIB | ⤷ Sign Up |
South Africa | 200707638 | Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sorafenib tosylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1140840 | PA2006008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
1140840 | 122006000059 | Germany | ⤷ Sign Up | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
1140840 | SZ 35/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON |
1140840 | SPC/GB07/004 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721 |
1140840 | CA 2007 00002 | Denmark | ⤷ Sign Up | PRODUCT NAME: SORAFENIB TOSYLAT |
1140840 | 35/2006 | Austria | ⤷ Sign Up | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
1140840 | PA2006008,C1140840 | Lithuania | ⤷ Sign Up | 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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