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Last Updated: April 26, 2024

SORAFENIB TOSYLATE - Generic Drug Details

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What are the generic drug sources for sorafenib tosylate and what is the scope of patent protection?

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
Guangzhou First People's Hospital	Phase 2/Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2/Phase 3

See all SORAFENIB TOSYLATE clinical trials

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

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Glossary

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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	⤷ 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
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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SORAFENIB TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Denmark	1868579		⤷ Try a Trial
Austria	E482693		⤷ Try a Trial
Hong Kong	1118019	用於治療癌症的包含ω-羧芳基取代的二苯基脲的藥物組合物 (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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.