You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 31, 2024

NEXAVAR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Nexavar patents expire, 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.

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for NEXAVAR?
  • What are the global sales for NEXAVAR?
  • What is Average Wholesale Price for NEXAVAR?
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
Second Xiangya Hospital of Central South UniversityPhase 2/Phase 3
Guangzhou First People's HospitalPhase 2/Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA, OR DIFFERENTIATED THYROID CARCINOMA.

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

Pharmaceutical composition for the treatment of cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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
>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 ⤷  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 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
Patent: COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 06222365
Patent: Pharmaceutical composition comprising an omega- carboxyaryl substituted diphenyl urea for the treatment of cancer
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 82693
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0608840
Patent: composição farmacêutica compreendendo uma difenil uréia substituìda por Èmega - carboxiarila para o tratamento de cáncer
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 01955
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHENYLUREE SUBSTITUEE PAR UN OMEGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1132779
Patent: Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer
Estimated Expiration: ⤷  Sign Up

Patent: 4688697
Patent: PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 48
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UNA DIFENILUREA SUSTITUIDA CON OMEGA-CARBOXIARILO PARA EL TRATAMIENTO DEL CANCER
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0100674
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 821
Patent: COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UNA DIFENILUREA SUSTITUIDA CON OMEGA-CARBOXIARILO PARA EL TRATAMIENTO DEL CÁNCER
Estimated Expiration: ⤷  Sign Up

Patent: 070203
Patent: COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UNA DIFENILUREA SUSTITUIDA CON OMEGA-CARBOXIARILO PARA EL TRATAMIENTO DEL CÁNCER
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 11065
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 68579
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 006000057
Patent: COMPOSICIÓN FARMACEÚTICA PARA EL TRATAMIENTO DEL CÁNCER
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 68579
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHÉNYLURÉE SUBSTITUÉE PAR UN OMÉGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2006017188
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 0600096
Patent: COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 06009702
Patent: COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 18019
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 09620
Patent: 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 (A PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 5517
Patent: תכשיר רוקחות המכיל דיפניל אוריאה המותמר בקרבוקסיל בעמדה אומגה לטיפול בסרטן (Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 04241
Estimated Expiration: ⤷  Sign Up

Patent: 08531741
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2319
Patent: PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07010856
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UNA DIFENILUREA SUSTITUIDA CON OMEGA-CARBOXIARILO PARA EL TRATAMIENTO DEL CANCER. (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA- CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 378
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHENYLUREE SUBSTITUEE PAR UN OMEGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 1178
Patent: Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 3834
Estimated Expiration: ⤷  Sign Up

Patent: 075042
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 061345
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE SORAFENIB
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 68579
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 68579
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 20283
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОМЕГАКАРБОКСИАРИЛЗАМЕЩЕННУЮ ДИФЕНИЛМОЧЕВИНУ, ДЛЯ ЛЕЧЕНИЯ РАКА (PHARMACEUTIC COMPOSITION CONTAINING OMAGACARBOXYARYL-SUBSTITUTED DIPHENYL UREA FOR CANCER TREATMENT)
Estimated Expiration: ⤷  Sign Up

Patent: 07136896
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОМЕГАКАРБОКСИАРИЛЗАМЕЩЕННУЮ ДИФЕНИЛМОЧЕВИНУ, ДЛЯ ЛЕЧЕНИЯ РАКА
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 0364
Patent: PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 68579
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0707638
Patent: Pharmaceutical composition comprising an omega-carboxyaryl substituted diphenyl urea for the treatment of cancer
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1335932
Estimated Expiration: ⤷  Sign Up

Patent: 070111513
Patent: PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 51612
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 24928
Estimated Expiration: ⤷  Sign Up

Patent: 0700093
Patent: Pharmaceutical composition for the treatment of cancer
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 07341
Patent: PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 673
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ СОДЕРЖИТ ОМЕГА-КАРБОКСИАРИЛЗАМЕЩЕННУЮ ДИФЕНИЛМОЧЕВИНУ, ДЛЯ ЛЕЧЕНИЯ PAKA;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА МІСТИТЬ ОМЕГА-КАРБОКСІАРИЛЗАМІЩЕНУ ДИФЕНІЛСЕЧОВИНУ, ДЛЯ ЛІКУВАННЯ РАКУ (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 410
Patent: COMPOSICIONES FARMACÉUTICAS EN BASE A METILAMIDAS DEL ÁCIDO 4-(4-/-3(-4-CLORO-3-TRIFLUOROMETIFENIL)UREIDO)FENOXI)PIRIDIN-2-CARBOXÍLICO, PROCEDIMIENTO DE PREPARACIÓN Y APLICACIONES.
Estimated Expiration: ⤷  Sign Up

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
New Zealand 556598 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors ⤷  Sign Up
Bulgaria 105763 ⤷  Sign Up
Peru 20142042 FORMA TERMODINAMICAMENTE ESTABLE DE UNA SAL TOSILATO DE SORAFENIB ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXAVAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140840 PA 2006 008, C 1140840 Lithuania ⤷  Sign Up PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 122006000059 Germany ⤷  Sign Up PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840 91280 Luxembourg ⤷  Sign Up 91280, EXPIRES: 20210720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.