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Last Updated: January 27, 2023

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 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 10th, 2020.

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Drug patent expirations by year for NEXAVAR
Drug Prices for NEXAVAR

See drug prices for NEXAVAR

Recent Clinical Trials for NEXAVAR

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

SponsorPhase
Jiangxi Province Children's HospitalPhase 2/Phase 3
The First Affiliated Hospital of Nanchang UniversityPhase 2/Phase 3
Second Xiangya Hospital of Central South UniversityPhase 2/Phase 3

See all NEXAVAR clinical trials

Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors
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

Aryl ureas with angiogenesis inhibiting activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

Thermodynamically stable form of a tosylate salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA.

Pharmaceutical composition for the treatment of cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA REFRACTORY TO RADIOACTIVE IODINE TREATMENT

Pharmaceutical composition for the treatment of cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

Pharmaceutical composition for the treatment of cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 4234
Estimated Expiration: See Plans and Pricing

Australia

Patent: 06222365
Estimated Expiration: See Plans and Pricing

Austria

Patent: 2693
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0608840
Estimated Expiration: See Plans and Pricing

Canada

Patent: 01955
Estimated Expiration: See Plans and Pricing

China

Patent: 1132779
Estimated Expiration: See Plans and Pricing

Patent: 4688697
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 48
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0100674
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 821
Estimated Expiration: See Plans and Pricing

Patent: 070203
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11065
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68579
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 006000057
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68579
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2006017188
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0600096
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 06009702
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 18019
Estimated Expiration: See Plans and Pricing

Patent: 09620
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5517
Estimated Expiration: See Plans and Pricing

Japan

Patent: 04241
Estimated Expiration: See Plans and Pricing

Patent: 08531741
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2319
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07010856
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 378
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1178
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3834
Estimated Expiration: See Plans and Pricing

Patent: 075042
Estimated Expiration: See Plans and Pricing

Peru

Patent: 061345
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68579
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68579
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 20283
Estimated Expiration: See Plans and Pricing

Patent: 07136896
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0364
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68579
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0707638
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1335932
Estimated Expiration: See Plans and Pricing

Patent: 070111513
Estimated Expiration: See Plans and Pricing

Spain

Patent: 51612
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 24928
Estimated Expiration: See Plans and Pricing

Patent: 0700093
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 07341
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 673
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
Taiwan I382016 See Plans and Pricing
Austria 482693 See Plans and Pricing
China 1341098 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXAVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 122006000059 Germany See Plans and Pricing PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 SPC 031/2006 Ireland See Plans and Pricing SPC 031/2006: 20070528, EXPIRES: 20210718
1140840 PA2006008 Lithuania See Plans and Pricing PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 06C0034 France See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
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Merck
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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.