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BRAFTOVI Drug Profile
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» See Plans and PricingWhich 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 thirty-one patent family members in forty-nine 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 November 21, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BRAFTOVI
| International Patents: | 131 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 37 |
| Clinical Trials: | 6 |
| Patent Applications: | 52 |
| 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 |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| University of California, San Francisco | Phase 1/Phase 2 |
| EADO - European Association of Dermato Oncology | 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 | 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 | |||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-001 | Jun 27, 2018 | DISCN | Yes | No | 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 BRAFTOVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Dominican Republic | P2012000051 | Start Trial |
| Poland | 2324008 | Start Trial |
| Japan | 5475888 | Start Trial |
| Montenegro | 02684 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRAFTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | 2019C/508 | Belgium | Start Trial | PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924 |
| 2470526 | 1990012-5 | Sweden | Start Trial | PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924 |
| 2470526 | 122019000021 | Germany | Start Trial | PRODUCT NAME: ENCORAFENIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
| 2470526 | CA 2019 00012 | Denmark | Start Trial | PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
