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
Jiangxi Province Children's Hospital	Phase 2/Phase 3
The First Affiliated Hospital of Nanchang University	Phase 2/Phase 3
First Affiliated Hospital of Shantou University Medical College	Phase 2/Phase 3

See all sorafenib tosylate clinical trials

Pharmacology for sorafenib tosylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sorafenib tosylate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Yabao Pharm	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209050-001	Nov 9, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Torrent	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	217095-001	Apr 12, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209567-001	Nov 12, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mylan	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	207012-001	Sep 10, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	216073-001	Jun 7, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Morocco	29378	COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHENYLUREE SUBSTITUEE PAR UN OMEGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER	⤷ Sign Up
Norway	20071508		⤷ Sign Up
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)	⤷ Sign Up
China	101132779	Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer	⤷ Sign Up
Peru	20060699	FORMA TERMODINAMICAMENTE ESTABLE DE UNA SAL TOSILATO	⤷ Sign Up
Norway	343834		⤷ Sign Up
South Korea	20090018224	THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE	⤷ Sign Up
>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	35/2006	Austria	⤷ Sign Up	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	PA2006008	Lithuania	⤷ Sign Up	PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; 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
1140840	CA 2007 00002	Denmark	⤷ Sign Up	PRODUCT NAME: SORAFENIB TOSYLAT
1140840	SZ 35/2006	Austria	⤷ Sign Up	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840	122006000059	Germany	⤷ Sign Up	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	06C0034	France	⤷ Sign Up	PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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