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BRAFTOVI Drug Profile
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Which patents cover Braftovi, and what generic alternatives are available?
Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this drug.
This drug has one hundred and eighty-one patent family members in fifty-one countries.
The generic ingredient in BRAFTOVI is encorafenib. One supplier is listed for this compound. Additional details are available on the encorafenib profile page.
US ANDA Litigation and Generic Entry Outlook for Braftovi
Braftovi will be eligible for patent challenges on June 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 5, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BRAFTOVI
| International Patents: | 181 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 7 |
| Patent Applications: | 54 |
| Drug Prices: | Drug price information for BRAFTOVI |
| DailyMed Link: | BRAFTOVI at DailyMed |
Generic Entry Opportunity Date for BRAFTOVI
Generic Entry Date for BRAFTOVI*:
Constraining patent/regulatory exclusivity:
NDA:
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 BRAFTOVI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Academic and Community Cancer Research United | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| EADO - European Association of Dermato Oncology | Phase 2 |
US Patents and Regulatory Information for BRAFTOVI
| 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 | 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 | Y | Start Trial | ||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| 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 | Start Trial | ||||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | 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 BRAFTOVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | 2882440 | Start Trial |
| South Korea | 20140095500 | Start Trial |
| Hungary | E032847 | Start Trial |
| Hong Kong | 1197024 | Start Trial |
| Hong Kong | 1167390 | Start Trial |
| Eurasian Patent Organization | 019722 | Start Trial |
| Japan | 2014098022 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRAFTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | PA2019005,C2470526 | Lithuania | Start Trial | PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
| 2470526 | C20190011 00282 | Estonia | Start Trial | PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018 |
| 2727918 | PA2019006 | Lithuania | Start Trial | 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 |
| 2470526 | C201930019 | Spain | Start Trial | PRODUCT NAME: ENCORAFENIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1314; DATE OF FIRST AUTHORISATION IN EEA: 20180920 |
| 2470526 | LUC00101 | Luxembourg | Start 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 |
| 2470526 | 19C1013 | France | Start Trial | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 2727918 | 300975 | Netherlands | Start 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 |
