Vemurafenib - Generic Drug Details
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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-eight patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for vemurafenib
| International Patents: | 198 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 149 |
| Patent Applications: | 7,190 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in vemurafenib? | vemurafenib excipients list |
| DailyMed Link: | vemurafenib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vemurafenib
Generic Entry Date for vemurafenib*:
Constraining patent/regulatory exclusivity:
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 vemurafenib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Birmingham | Phase 2/Phase 3 |
| Cancer Research UK | Phase 2/Phase 3 |
| Royal Marsden NHS Foundation Trust | Phase 2/Phase 3 |
Pharmacology for vemurafenib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for vemurafenib
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Roche Registration GmbH | Zelboraf | vemurafenib | EMEA/H/C/002409 Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma., |
Authorised | no | no | no | 2012-02-17 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for vemurafenib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2006272951 | Pyrrol (2,3-b) pyridine derivatives protein kinase inhibitors | ⤷ Try a Trial |
| Brazil | PI0611863 | composto, bem como composiÇço e kit compreendendo o mesmo, composto intermediÁrio na preparaÇço do mesmo, mÉtodo para tratamento e uso do mesmo | ⤷ Try a Trial |
| Russian Federation | 2418800 | ПИРРОЛО[2, 3-В]ПИРИДИНОВЫЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗ (PYRROLO[2,3-B]PYRIDINE DERIVATIVE AS PROTEIN KINASE INHIBITORS) | ⤷ Try a Trial |
| Mexico | 2011008303 | COMPOSICIONES DEL ACIDO PROPANO-1-SULFONICO {3-[5-(4-CLORO-FENIL)- 1H-PIRROLO [2,3-B]-PIRIDINA-3-CARBONIL]-2,4-DIFLUORO-FENIL}-AMIDA Y EL USO DE LAS MISMAS. (PROPANE- I-SULFONIC ACID {3- [5- (4 -CHLORO-PHENYL) -1H-PYRROLO [2, 3-B] PYRIDINE-3-CARBONYL] -2, 4-DIFLUORO-PHENY L } -AMIDE COMPOSITIONS AND USES THEREOF.) | ⤷ Try a Trial |
| South Korea | 101440257 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vemurafenib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1893612 | CA 2012 00028 | Denmark | ⤷ Try a Trial | |
| 1893612 | 2012/025 | Ireland | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
| 1893612 | C20120016 00059 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ZELBORAF - VEMURAFENIIB;REG NO/DATE: C(2012)1180 FINAL 17.02.2012 |
| 1893612 | PA2012010,C1893612 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
| 1893612 | 132012902073472 | Italy | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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