DrugPatentWatch Database Preview
NEXAVAR Drug Profile
» See Plans and Pricing
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 eight patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and fifteen patent family members in fifty-six countries.
The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.
US ANDA Litigation and Generic Entry Outlook for Nexavar
Nexavar was eligible for patent challenges on December 20, 2009.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 10, 2028. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for NEXAVAR
| International Patents: | 215 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 120 |
| Clinical Trials: | 287 |
| Patent Applications: | 1,984 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NEXAVAR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEXAVAR |
| DailyMed Link: | NEXAVAR at DailyMed |
Generic Entry Opportunity Date for NEXAVAR
Generic Entry Date for NEXAVAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for NEXAVAR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| First Affiliated Hospital of Zhejiang University | Phase 3 |
| Yiviva Inc. | Phase 2 |
| Institut du Cancer de Montpellier - Val d'Aurelle | Phase 3 |
Pharmacology for NEXAVAR
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for NEXAVAR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NEXAVAR | TABLET;ORAL | sorafenib tosylate | 021923 | 2014-02-28 |
US Patents and Regulatory Information for NEXAVAR
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | Start Trial | Start Trial |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | Start Trial | Start Trial |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | Start Trial | Start Trial |
| Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NEXAVAR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Malaysia | 138897 | Start Trial |
| Spain | 2255971 | Start Trial |
| European Patent Office | 1690853 | Start Trial |
| Norway | 20055863 | Start Trial |
| Japan | 4359817 | Start Trial |
| Mexico | 2007010856 | Start Trial |
| Australia | 2002238042 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEXAVAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1140840 | C01140840/01 | Switzerland | Start Trial | FORMER OWNER: BAYER HEALTHCARE LLC, US |
| 1140840 | SPC/GB07/004 | United Kingdom | Start Trial | PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721 |
| 1140840 | 91280 | Luxembourg | Start Trial | 91280, EXPIRES: 20210720 |
| 1140840 | PA 2006 008, C 1140840 | Lithuania | Start Trial | PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| 1140840 | 06C0034 | France | Start Trial | 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 |
| 1140840 | 295 | Finland | Start Trial | |
| 1140840 | PA2006008,C1140840 | Lithuania | Start Trial | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
