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-five patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for ENCORAFENIB
| International Patents: | 195 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 67 |
| 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
*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 |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| University of Utah | Phase 1/Phase 2 |
| Verastem, Inc. | Phase 1/Phase 2 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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 | 3449911 | FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS) | ⤷ Sign Up |
| South Korea | 20120062839 | COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS | ⤷ Sign Up |
| Mexico | 353446 | FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.) | ⤷ Sign Up |
| Argentina | 092045 | COMBINACIONES FARMACEUTICAS | ⤷ Sign Up |
| Taiwan | 201328722 | Pharmaceutical formulations | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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 | 19C1013 | France | ⤷ Sign Up | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 2470526 | LUC00101 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924 |
| 2470526 | C02470526/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019 |
| 2727918 | PA2019006 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BINIMETINIBO IR ENKORAFENIBO, KIEKVIENO BET KURIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA, DERINYS; REGISTRATION NO/DATE: EU/1/18/1314, EU/1/18/1835 20190920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
