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Vemurafenib - Generic Drug Details
What are the generic sources for vemurafenib and what is the scope of freedom to operate?
Vemurafenib
is the generic ingredient in one branded drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vemurafenib has one hundred and ninety-two patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for vemurafenib
| International Patents: | 192 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 130 |
| Patent Applications: | 242 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | vemurafenib at DailyMed |
Recent Clinical Trials for vemurafenib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Acrotech Biopharma | Phase 1 |
| Novartis | Phase 1 |
| OHSU Knight Cancer Institute | Phase 1 |
Pharmacology for vemurafenib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for vemurafenib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
International Patents for vemurafenib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20120876 | Start Trial |
| Dominican Republic | P2011000291 | Start Trial |
| Japan | 2012522791 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for vemurafenib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1893612 | PA2012010 | Lithuania | Start Trial | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
| 1893612 | 92035 | Luxembourg | Start Trial | 92035, EXPIRES: 20270217 |
| 1893612 | 132012902073472 | Italy | Start Trial | PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120217 |
| >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.
ISSN: 2162-2639
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