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Last Updated: June 29, 2022

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 eighty-eight patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib
International Patents:188
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 52
Patent Applications: 1,641
What excipients (inactive ingredients) are in encorafenib?encorafenib excipients list
DailyMed Link:encorafenib at DailyMed
Recent Clinical Trials for encorafenib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr. Ronnie ShapiraPhase 2
European Organisation for Research and Treatment of Cancer - EORTCPhase 3
Eli Lilly and CompanyPhase 2

See all encorafenib clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
World Intellectual Property Organization (WIPO) 2010010154 See Plans and Pricing
Serbia 53489 JEDINJENJA I PREPARATI PROTEIN KINAZNIH INHIBITORA (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Spain 2695099 See Plans and Pricing
South Korea 20140095500 PHARMACEUTICAL FORMULATIONS See Plans and Pricing
Mexico 2014006278 FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.) See Plans and Pricing
Jordan 3493 صيغ صيدلانية (PHARMACEUTICAL FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for encorafenib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 7-2019 Slovakia See Plans and Pricing PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 C02470526/01 Switzerland See Plans and Pricing PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
2470526 2019012 Norway See Plans and Pricing PRODUCT NAME: ENKORAFENIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT DERAV; REG. NO/DATE: EU/1/18/1314 20180925
2470526 132019000000047 Italy See Plans and Pricing 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 2019/012 Ireland See Plans and Pricing PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 C20190011 00282 Estonia See Plans and Pricing PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Dow
Baxter
Colorcon
Moodys

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