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

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	NDA	Submissiondate
NEXAVAR	TABLET;ORAL	sorafenib tosylate	021923	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	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

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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	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

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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

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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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