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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 eleven patents protecting this drug.
This drug has one hundred and thirty 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.
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.
Summary for BRAFTOVI
| International Patents: | 130 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 37 |
| Clinical Trials: | 5 |
| 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 |
|---|---|
| UNICANCER | Phase 2 |
| Bristol-Myers Squibb (BMS) | Phase 1/Phase 2 |
| University of California, San Francisco | 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 | 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 BRAFTOVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 2470526 | Start Trial |
| Israel | 232305 | Start Trial |
| Taiwan | 201328722 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRAFTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2727918 | 122019000023 | Germany | Start Trial | |
| 2470526 | LUC00101 | Luxembourg | Start Trial | PRODUCT NAME: BRAFTOVI - ENCORAFENIB; AUTHORISATION NUMBER AND 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 |
