VEMURAFENIB - Generic Drug Details
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What are the generic drug 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 |
Anatomical Therapeutic Chemical (ATC) Classes for VEMURAFENIB
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Hoffmann La Roche | ZELBORAF | vemurafenib | TABLET;ORAL | 202429-001 | Aug 17, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 |
---|---|---|---|
European Patent Office | 1893612 | DERIVES DE PYRROLO [2, 3-B]PYRIDINE UTILISES COMME INHIBITEURS DE PROTEINES KINASES (PYRROLO [2, 3-B]PYRIDINE DERIVATIVES AS PROTEIN KINASE INHIBITORS) | ⤷ Sign Up |
Spain | 2552386 | ⤷ Sign Up | |
Eurasian Patent Organization | 201591240 | КОМПОЗИЦИИ {3-[5-(4-ХЛОРФЕНИЛ)-1H-ПИРРОЛО[2,3-B]ПИРИДИН-3-КАРБОНИЛ]-2,4-ДИФТОРФЕНИЛ}АМИДА ПРОПАН-1-СУЛЬФОНОВОЙ КИСЛОТЫ И ИХ ПРИМЕНЕНИЕ | ⤷ Sign Up |
South Korea | 20130128488 | PROCESS FOR THE MANUFACTURE OF INTERMEDIATES FOR PREPARING PHARMACEUTICALLY ACTIVE COMPOUNDS | ⤷ Sign Up |
New Zealand | 594398 | Propane-1-sulfonic acid (3-[5-(4-chloro-phenyl)-1h-pyrrol [2, 3-b] pyridine-3-carbonyl]-2,4-difluoro-phenyl} -amide compositions and uses thereof | ⤷ Sign Up |
Israel | 238337 | תהליך להכנת תרכובות פעילות פרמצבטית (Process for the manufacture of pharmaceutically active compounds) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEMURAFENIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1893612 | PA2012010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
1893612 | C01893612/01 | Switzerland | ⤷ Sign Up | VERTRETERLOESCHUNG |
1893612 | 132012902073472 | Italy | ⤷ Sign Up | PRODUCT NAME: VEMURAFENIB(ZELBORAF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/751/001, 20120221 |
1893612 | 122, 5012-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217 |
1893612 | 92035 | Luxembourg | ⤷ Sign Up | 92035, EXPIRES: 20270217 |
1893612 | C 2012 020 | Romania | ⤷ Sign Up | PRODUCT NAME: VEMURAFENIB SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20120217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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