ENCORAFENIB - Generic Drug Details
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What are the generic drug sources for encorafenib and what is the scope of freedom to operate?
Encorafenib
is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Encorafenib has one hundred and ninety-four patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for ENCORAFENIB
International Patents: | 194 |
US Patents: | 13 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 62 |
Patent Applications: | 1,637 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENCORAFENIB |
What excipients (inactive ingredients) are in ENCORAFENIB? | ENCORAFENIB excipients list |
DailyMed Link: | ENCORAFENIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ENCORAFENIB
Generic Entry Date for ENCORAFENIB*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 ENCORAFENIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc | Phase 1/Phase 2 |
National Cancer Institute (NCI) | Phase 2/Phase 3 |
Alliance for Clinical Trials in Oncology | Phase 2/Phase 3 |
Paragraph IV (Patent) Challenges for ENCORAFENIB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BRAFTOVI | Capsules | encorafenib | 75 mg | 210496 | 3 | 2022-06-27 |
US Patents and Regulatory Information for ENCORAFENIB
EU/EMA Drug Approvals for ENCORAFENIB
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Pierre Fabre Medicament | Braftovi | encorafenib | EMEA/H/C/004580 Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy |
Authorised | no | no | no | 2018-09-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ENCORAFENIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2470526 | COMPOSÉS ET COMPOSITIONS EN TANT QU'INHIBITEURS DE PROTÉINE KINASE (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS) | ⤷ Try a Trial |
Cyprus | 1121421 | ⤷ Try a Trial | |
Croatia | P20170005 | ⤷ Try a Trial | |
European Patent Office | 2727918 | Composés et compositions en tant qu'inhibiteurs de protéine kinase (Compounds and Compositions as Protein Kinase Inhibitors) | ⤷ Try a Trial |
New Zealand | 703940 | Pharmaceutical combinations comprising a b-raf inhibitor, an egfr inhibitor and optionally a pi3k-alpha inhibitor | ⤷ Try a Trial |
Uruguay | 32860 | COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENCORAFENIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2470526 | 2019C/508 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
2470526 | 1990012-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924 |
2470526 | C02470526/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019 |
2470526 | 122019000021 | Germany | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
2727918 | 122019000023 | Germany | ⤷ Try a Trial | |
2470526 | 2019/012 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |