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Last Updated: April 24, 2024

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 two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine 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. Eight 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
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 2/Phase 3
Maternal and Child Health Hospital of FoshanPhase 2/Phase 3
First Affiliated Hospital of Shantou University Medical CollegePhase 2/Phase 3

See all NEXAVAR clinical trials

Pharmacology for NEXAVAR
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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 four US patents.

Patents protecting NEXAVAR

Thermodynamically stable form of a tosylate salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA.

Pharmaceutical composition for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA

Pharmaceutical composition for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 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 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare NEXAVAR sorafenib tosylate TABLET;ORAL 021923-001 Dec 20, 2005 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

Patent: 06222365
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 82693
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0608840
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 01955
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1132779
Estimated Expiration: ⤷  Try a Trial

Patent: 4688697
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 48
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0100674
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 821
Estimated Expiration: ⤷  Try a Trial

Patent: 070203
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11065
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68579
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 006000057
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68579
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2006017188
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0600096
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 06009702
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 18019
Estimated Expiration: ⤷  Try a Trial

Patent: 09620
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5517
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 04241
Estimated Expiration: ⤷  Try a Trial

Patent: 08531741
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2319
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07010856
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 378
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1178
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3834
Estimated Expiration: ⤷  Try a Trial

Patent: 075042
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 061345
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68579
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68579
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 20283
Estimated Expiration: ⤷  Try a Trial

Patent: 07136896
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 0364
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68579
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0707638
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1335932
Estimated Expiration: ⤷  Try a Trial

Patent: 070111513
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 51612
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 24928
Estimated Expiration: ⤷  Try a Trial

Patent: 0700093
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 07341
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 673
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 410
Estimated Expiration: ⤷  Try a Trial

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
Portugal 1868579 ⤷  Try a Trial
Slovenia 1868579 ⤷  Try a Trial
Peru 20100445 FORMA TERMODINAMICAMENTE ESTABLE DE UNA SAL TOSILATO DE SORAFENIB ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXAVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 SZ 35/2006 Austria ⤷  Try a Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840 PA2006008,C1140840 Lithuania ⤷  Try a Trial PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 35/2006 Austria ⤷  Try a Trial PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.