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Generated: July 21, 2017
What is the patent landscape for Nexavar, and what generic Nexavar alternatives are available?
Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.| Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 84 |
| Clinical Trials: see list | 275 |
| Patent Applications: see list | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | NEXAVAR at DailyMed |
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
| 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 | 7,351,834 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | 8,618,141 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | 8,841,330 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Bayer Hlthcare | NEXAVAR | sorafenib tosylate | TABLET;ORAL | 021923-001 | Dec 20, 2005 | RX | Yes | Yes | 7,897,623 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sorafenib tosylate | Tablets | 200 mg | Nexavar | 2/28/2014 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,528,255 | Hydroxy, .omega.-carboxyaryl substituted diphenyl ureas and dirivatives thereof as raf kinase inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,838,541 | Aryl ureas with angiogenesis inhibiting activity | ► Subscribe | |||||||||||||||||||||||||||
| 7,928,239 | Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas | ► Subscribe | |||||||||||||||||||||||||||
| 8,242,147 | Aryl ureas with angiogenisis inhibiting activity | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Czech Republic | 302846 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 1797038 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 4636486 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 077485 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101381454 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2006008 | Lithuania | ► Subscribe | PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 | ||||||||||||||||||||||||||
| 2006000059 | Germany | ► Subscribe | PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719 | ||||||||||||||||||||||||||
| 1140840/01 | Switzerland | ► Subscribe | FORMER REPRESENTANTIVE: A. BRAUN, BRAUN, HERITIER, ESCHMANN AG PATENTANWAELTE, CH | ||||||||||||||||||||||||||
| C 031/2006 | Ireland | ► Subscribe | SPC 031/2006: 20070528, EXPIRES: 20210718 | ||||||||||||||||||||||||||
| 280 | Luxembourg | ► Subscribe | 91280, EXPIRES: 20210720 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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