Sorafenib tosylate - Generic Drug Details
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What are the generic drug 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 |
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 |
---|---|
Second Xiangya Hospital of Central South University | Phase 2/Phase 3 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2/Phase 3 |
Guangzhou First People's Hospital | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
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 | |
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 | |||
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 | |||
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 | |||
>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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sorafenib tosylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Tunisia | SN07341 | PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER | ⤷ Try a Trial |
South Korea | 20090018224 | THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE | ⤷ Try a Trial |
Malaysia | 176929 | THERMODYNAMICALLY STABLE FORM OF A TOSYLATE SALT | ⤷ Try a Trial |
South Africa | 200707638 | Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer | ⤷ Try a Trial |
South Korea | 101335932 | ⤷ 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 | 122006000059 | Germany | ⤷ Try a Trial | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 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 | CA 2007 00002 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SORAFENIB TOSYLAT |
1140840 | PA 2006 008, C 1140840 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; 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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