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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.
Summary for sorafenib tosylate
International Patents: | 215 |
US Patents: | 8 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 13 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 101 |
Clinical Trials: | 158 |
Patent Applications: | 6 |
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 |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
University of Washington | Phase 1/Phase 2 |
Memorial Sloan Kettering Cancer Center | Phase 1 |
Pharmacology for sorafenib tosylate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein 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 |
International Patents for sorafenib tosylate
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1113598 | Start Trial |
Canada | 2581843 | Start Trial |
Czech Republic | 299125 | Start Trial |
Spain | 2351612 | Start Trial |
South Korea | 20090018224 | Start Trial |
Colombia | 5170439 | Start Trial |
Bulgaria | 105763 | Start Trial |
>Country | >Patent Number | >Estimated 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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