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.
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 |


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 |
Pharmacology for NEXAVAR
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NEXAVAR
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 |