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BRAFTOVI Drug Profile
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 eleven patents protecting this drug.
This drug has one hundred and twenty-six patent family members in forty-eight countries.
The generic ingredient in BRAFTOVI is encorafenib. One supplier is listed for this compound. Additional details are available on the encorafenib profile page.
Summary for BRAFTOVI
| International Patents: | 126 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 5 |
| Patent Applications: | 50 |
| 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 |
|---|---|
| University of California, San Francisco | Phase 1/Phase 2 |
| EADO - European Association of Dermato Oncology | Phase 2 |
| Array BioPharma | Phase 1/Phase 2 |
Synonyms for BRAFTOVI
| 1269440-17-6 |
| 8L7891MRB6 |
| A13226 |
| AC-30230 |
| AS-35201 |
| BCP08458 |
| BDBM221688 |
| Braftovi (TN) |
| Carbamic acid, N-[(1S)-2-[[4-[3-[5-chloro-2-fluoro-3-[(methylsulfonyl)amino]phenyl]-1-(1-methylethyl)-1H-pyrazol-4-yl]-2-pyrimidinyl]amino]-1-methylethyl]-, methyl ester |
| CHEMBL3301612 |
| CMJCXYNUCSMDBY-ZDUSSCGKSA-N |
| CS-2289 |
| D11053 |
| DB11718 |
| DTXSID00155347 |
| Encorafenib |
| Encorafenib (JAN/USAN/INN) |
| Encorafenib (LGX818) |
| Encorafenib [USAN:INN] |
| EX-A1587 |
| GTPL7908 |
| HY-15605 |
| LGX 818 |
| LGX-818 |
| LGX-818(Encorafenib) |
| LGX818 |
| Methyl N-[(2S)-1-({4-[3-(5-chloro-2-fluoro-3-methanesulfonamidophenyl)-1-(propan-2-yl)-1H-pyrazol-4-yl]pyrimidin-2-yl}amino)propan-2-yl]carbamate |
| methyl N-[(2S)-1-[[4-[3-[5-chloro-2-fluoro-3-(methanesulfonamido)phenyl]-1-propan-2-ylpyrazol-4-yl]pyrimidin-2-yl]amino]propan-2-yl]carbamate |
| MFCD25976758 |
| NCGC00378599-03 |
| NVP-LGX818 |
| NVP-LGX818-NXA |
| s7108 |
| SB16926 |
| SCHEMBL8228295 |
| UNII-8L7891MRB6 |
| US9314464, 9 |
| ZINC68249103 |
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 | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | See Pricing | See Pricing | See Pricing | ||||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | See Pricing | See Pricing | Y | Y | See Pricing | ||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| >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 |
|---|---|---|
| Serbia | 55568 | See Pricing |
| Philippines | 12014501157 | See Pricing |
| Tunisia | 2012000081 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRAFTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2727918 | 300975 | Netherlands | See Pricing | PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 2470526 | PA2019005 | Lithuania | See Pricing | PRODUCT NAME: ENKORAFENIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
| 2470526 | LUC00101 | Luxembourg | See Pricing | PRODUCT NAME: BRAFTOVI - ENCORAFENIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
