ZELBORAF Drug Patent Profile
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Which patents cover Zelboraf, and when can generic versions of Zelboraf launch?
Zelboraf is a drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and ninety-seven patent family members in forty-six countries.
The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
DrugPatentWatch® Generic Entry Outlook for Zelboraf
Zelboraf was eligible for patent challenges on August 17, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 6, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ZELBORAF
International Patents: | 197 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 53 |
Patent Applications: | 3,419 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZELBORAF |
What excipients (inactive ingredients) are in ZELBORAF? | ZELBORAF excipients list |
DailyMed Link: | ZELBORAF at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZELBORAF
Generic Entry Date for ZELBORAF*:
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 ZELBORAF
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Royal Marsden NHS Foundation Trust | Phase 2/Phase 3 |
University of Manchester | Phase 2/Phase 3 |
Hoffmann-La Roche | Phase 2/Phase 3 |
Pharmacology for ZELBORAF
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZELBORAF
US Patents and Regulatory Information for ZELBORAF
ZELBORAF is protected by seven US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZELBORAF is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZELBORAF
Compounds and methods for development of Ret modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and methods for kinase modulation, and indications therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and methods for kinase modulation, and indications therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and methods for kinase modulation, and indications therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ZELBORAF IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Compounds and methods for kinase modulation, and indications therefor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E MUTATION AS DETECTED BY AN FDA APPROVED TEST
Process for the manufacture of pharmaceutically active compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting ZELBORAF
TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Exclusivity Expiration: ⤷ Try a Trial
EU/EMA Drug Approvals for ZELBORAF
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 ZELBORAF
When does loss-of-exclusivity occur for ZELBORAF?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8033
Estimated Expiration: ⤷ Try a Trial
Patent: 1037
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 10232670
Estimated Expiration: ⤷ Try a Trial
Patent: 10318049
Estimated Expiration: ⤷ Try a Trial
Patent: 15238857
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1008709
Estimated Expiration: ⤷ Try a Trial
Patent: 2012009609
Estimated Expiration: ⤷ Try a Trial
Patent: 2020005420
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 38573
Estimated Expiration: ⤷ Try a Trial
Patent: 78693
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1761378
Estimated Expiration: ⤷ Try a Trial
Patent: 2361870
Estimated Expiration: ⤷ Try a Trial
Patent: 2596953
Estimated Expiration: ⤷ Try a Trial
Patent: 5237530
Estimated Expiration: ⤷ Try a Trial
Patent: 0269838
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 10296
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 110420
Estimated Expiration: ⤷ Try a Trial
Patent: 170089
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0151156
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 16983
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 14356
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 011000291
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 11011282
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 11004004
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2924
Estimated Expiration: ⤷ Try a Trial
Patent: 1116
Estimated Expiration: ⤷ Try a Trial
Patent: 1190098
Estimated Expiration: ⤷ Try a Trial
Patent: 1591240
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 99559
Estimated Expiration: ⤷ Try a Trial
Patent: 14356
Estimated Expiration: ⤷ Try a Trial
Patent: 99138
Estimated Expiration: ⤷ Try a Trial
Patent: 55180
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2008061829
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 11002147
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 68590
Estimated Expiration: ⤷ Try a Trial
Patent: 17195
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 27598
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4328
Estimated Expiration: ⤷ Try a Trial
Patent: 1336
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 11942
Estimated Expiration: ⤷ Try a Trial
Patent: 12522791
Estimated Expiration: ⤷ Try a Trial
Patent: 13510813
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 56
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 0737
Estimated Expiration: ⤷ Try a Trial
Patent: 2424
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 9923
Estimated Expiration: ⤷ Try a Trial
Patent: 11008303
Estimated Expiration: ⤷ Try a Trial
Patent: 12005224
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 028
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4398
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1100161
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 120876
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 14356
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 14356
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 12123958
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01500302
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3178
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 14356
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1202937
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1739994
Estimated Expiration: ⤷ Try a Trial
Patent: 120006006
Estimated Expiration: ⤷ Try a Trial
Patent: 120101439
Estimated Expiration: ⤷ Try a Trial
Patent: 170058465
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 52386
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 04719
Estimated Expiration: ⤷ Try a Trial
Patent: 1040179
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 11000436
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 8842
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 540
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZELBORAF around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 108842 | ТВЕРДА ДИСПЕРСІЯ, СПОСІБ ЇЇ ОДЕРЖАННЯ, А ТАКОЖ КОМПОЗИЦІЯ І ЛІКАРСЬКА ФОРМА, ЩО ЇЇ МІСТЯТЬ | ⤷ Try a Trial |
Hungary | E027370 | ⤷ 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 | 340572 | PROCESO PARA LA FABRICACION DE COMPUESTOS FARMACEUTICAMENTE ACTIVOS. (PROCESS FOR THE MANUFACTURE OF PHARMACEUTICALLY ACTIVE COMPOUNDS.) | ⤷ Try a Trial |
South Africa | 201202025 | INTERMEDIATES USEFUL IN THE PREPARATION OF PYRROLO[2,3-b] PYRIDINE DERIVATIVES | ⤷ Try a Trial |
Slovenia | 2395004 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2011015522 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZELBORAF
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1893612 | 1290026-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217 |
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 | PA2012010,C1893612 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
1893612 | C01893612/01 | Switzerland | ⤷ Try a Trial | VERTRETERLOESCHUNG |
1893612 | PA2012010 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217 |
1893612 | C 2012 020 | Romania | ⤷ Try a Trial | 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 |
1893612 | 2012C/028 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |