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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Summary for NEXAVAR
| International Patents: | 89 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 152 |
| Clinical Trials: | 300 |
| Patent Applications: | 1,728 |
| 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 |
Recent Clinical Trials for NEXAVAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Maternal and Child Health Hospital of Foshan | Phase 2/Phase 3 |
| First Affiliated Hospital of Shantou University Medical College | Phase 2/Phase 3 |
| Third Affiliated Hospital, Sun Yat-Sen University | Phase 2/Phase 3 |
Pharmacology for NEXAVAR
| Drug Class | Kinase 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 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 |
| 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 |
|---|---|---|---|
| Slovakia | 9882001 | OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006094626 | ⤷ Sign Up | |
| European Patent Office | 1379507 | UREES HETEROARYLES CONTENANT DES HETERO-ATOMES D'AZOTE COMME INHIBITEURS DE KINASE P38 (HETEROARYL UREAS CONTAINING NITROGEN HETERO-ATOMS AS p38 KINASE INHIBITORS) | ⤷ Sign Up |
| Argentina | 077485 | DIFENILUREAS SUBSTITUIDAS CON CARBOXIARILO COMO INHIBIDORES DE RAF QUINASA | ⤷ Sign Up |
| Hong Kong | 1209620 | 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) | ⤷ 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 | PA2006008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 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 | PA2006008,C1140840 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 1140840 | CA 2007 00002 | Denmark | ⤷ Sign Up | PRODUCT NAME: SORAFENIB TOSYLAT |
| 1140840 | SPC 031/2006 | Ireland | ⤷ Sign Up | SPC 031/2006: 20070528, EXPIRES: 20210718 |
| >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.
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