NEXAVAR Drug Patent Profile

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 three 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. Six suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexavar

A generic version of NEXAVAR was approved as sorafenib tosylate by MYLAN on September 10^th, 2020.

Summary for NEXAVAR

International Patents:	103
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	153
Clinical Trials:	300
Patent Applications:	4,320
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
Jiangxi Province Children's Hospital	Phase 2/Phase 3
The First Affiliated Hospital of Nanchang University	Phase 2/Phase 3
Second Xiangya Hospital of Central South University	Phase 2/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	Strength	NDA	ANDAs Submitted	Submissiondate
NEXAVAR	Tablets	sorafenib tosylate	200 mg	021923	1	2014-02-28

US Patents and Regulatory Information for NEXAVAR

NEXAVAR is protected by five US patents.

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

International Patents for NEXAVAR

When does loss-of-exclusivity occur for NEXAVAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

European Patent Office

Germany

Guatemala

Honduras

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NEXAVAR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2008531741
Taiwan	I382016
Austria	482693
China	1341098

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	SPC 031/2006	Ireland		SPC 031/2006: 20070528, EXPIRES: 20210718
1140840	PA2006008	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	06C0034	France		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