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Encorafenib - Generic Drug Details
» See Plans and Pricing
What are the generic 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-two patent family members in fifty-one countries.
One supplier is listed for this compound.
Summary for encorafenib
| International Patents: | 182 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,253 |
| DailyMed Link: | encorafenib at DailyMed |
Recent Clinical Trials for encorafenib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ono Pharmaceutical Co. Ltd | Phase 3 |
| Pfizer | Phase 3 |
| Merck KGaA, Darmstadt, Germany | Phase 3 |
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 | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for encorafenib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2470526 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011025927 | Start Trial |
| Morocco | 35716 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for encorafenib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2727918 | 2019C/509 | Belgium | Start Trial | PRODUCT NAME: COMBINAISON DE BINIMETINIB ET D'ENCORAFENIB, CHACUN SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 ET EU/1/18/1314 20180924 |
| 2470526 | CR 2019 00012 | Denmark | Start Trial | PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924 |
| 2470526 | 300973 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
