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NEXAVAR Drug Patent Profile

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Which patents cover Nexavar, and when can generic versions of Nexavar launch?

Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in thirty-nine countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nexavar

Nexavar was eligible for patent challenges on December 20, 2009.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEXAVAR

International Patents:	102
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	289
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXAVAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXAVAR
What excipients (inactive ingredients) are in NEXAVAR?	NEXAVAR excipients list
DailyMed Link:	NEXAVAR at DailyMed

See drug prices for NEXAVAR

Recent Clinical Trials for NEXAVAR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mina Alpha Limited	Phase 2
China Medical University Hospital	Phase 4
First Affiliated Hospital of Zhejiang University	Phase 3

See all NEXAVAR clinical trials

Pharmacology for NEXAVAR

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NEXAVAR

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

Paragraph IV (Patent) Challenges for NEXAVAR

Tradename	Dosage	Ingredient	NDA	Submissiondate
NEXAVAR	TABLET;ORAL	sorafenib tosylate	021923	2014-02-28

US Patents and Regulatory Information for NEXAVAR

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		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes			Y	Y
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005		RX	Yes	Yes			Y

Expired US Patents for NEXAVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005

International Patents for NEXAVAR

Country	Patent Number	Estimated Expiration
Peru	20060699
Ecuador	SP077356
Canada	2601955
Peru	20061345
Hong Kong	1209620

Supplementary Protection Certificates for NEXAVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	122006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	SZ 35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840	PA2006008	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1140840	295	Finland