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-two patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for encorafenib
International Patents: | 192 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for encorafenib
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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 |
---|---|---|---|
Eurasian Patent Organization | 028420 | ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ, СОДЕРЖАЩИЕ ИНГИБИТОР B-RAF, ИНГИБИТОР EGFR И, НЕОБЯЗАТЕЛЬНО, ИНГИБИТОР PI3K-АЛЬФА (PHARMACEUTICAL COMBINATIONS COMPRISING A B-Raf INHIBITOR, AN EGFR INHIBITOR AND OPTIONALLY A PI3K-ALPHA INHIBITOR) | ⤷ Try a Trial |
India | 2469DEN2012 | ⤷ Try a Trial | |
Spain | 2717911 | ⤷ Try a Trial | |
Denmark | 2727918 | ⤷ Try a Trial | |
Cuba | 24110 | 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 | 132019000000047 | Italy | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(BRAFTOVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1314, 20180924 |
2470526 | PA2019005,C2470526 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
2470526 | C20190011 00282 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018 |
2470526 | LUC00101 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924 |
2727918 | 300975 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |