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Binimetinib - Generic Drug Details
What are the generic drug sources for binimetinib and what is the scope of freedom to operate?
Binimetinib
is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Binimetinib has two hundred and eight patent family members in fifty-two countries.
One supplier is listed for this compound.
Summary for binimetinib
| International Patents: | 208 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 68 |
| Clinical Trials: | 40 |
| Patent Applications: | 193 |
| DailyMed Link: | binimetinib at DailyMed |
Recent Clinical Trials for binimetinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| InxMed (Shanghai) Co., Ltd. | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
Synonyms for binimetinib
| 181R97MR71 |
| 5-((4-bromo-2-fluorophenyl)amino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzo[d]imidazole-6-carboxamide |
| 5-(4-Bromo-2-fluoroanilino)-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide |
| 5-[(4-Bromo-2-Fluorophenyl)Amino]-4-Fluoro-N-(2-Hydroxyethoxy)-1-Methyl-1H-Benzimidazole-6-Carboxami |
| 5-[(4-Bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide |
| 6-(4-bromo-2-fluoroanilino)-7-fluoro-N-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamide |
| 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide |
| 6-(4-bromo-2-fluorophenylamino)-7-fluoro-N-(2-hydroxyethoxy)-3-methyl-3H-benzo[d]imidazole-5-carboxamide |
| 6-[(4-bromo-2-fluorophenyl)amino]-7-fluoro-N-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamide |
| 606143-89-9 |
| A11493 |
| AB0095018 |
| AC-29023 |
| ACWZRVQXLIRSDF-UHFFFAOYSA-N |
| AK175886 |
| AKOS026750517 |
| AOB2072 |
| ARRY 162 |
| ARRY 438162 |
| ARRY-162 |
| ARRY-162,MEK-162 |
| ARRY-162; ARRY-438162; MEK 162; ARRY 162; ARRY 438162 |
| ARRY-438162 |
| AS-16706 |
| BC600594 |
| BCP06780 |
| Binimetinib (JAN/USAN) |
| Binimetinib (MEK162, ARRY-162, ARRY-438162) |
| Binimetinib [USAN:INN] |
| Binimetinib;MEK-162; ARRY-162;ARRY-438162 |
| C17H15BrF2N4O3 |
| cas:606143-89-9;MEK162 |
| CHEMBL3187723 |
| CS-0627 |
| D10604 |
| DB11967 |
| DTXSID70209422 |
| EX-A1024 |
| FT-0697088 |
| GTPL7921 |
| HMS3652J14 |
| HY-15202 |
| J-516581 |
| KS-0000062X |
| MEK-162 |
| MEK162 |
| MEK162 (ARRY-162, ARRY-438162) |
| MEK162 (Arry-162) |
| MEK162(Binimetinib) |
| Mektovi |
| MFCD22124525 |
| MLS006011180 |
| NCGC00345804-01 |
| NCGC00345804-10 |
| NVP-MEK162 |
| QCR-138 |
| RL04283 |
| s7007 |
| SB16501 |
| SCHEMBL570088 |
| SMR004702949 |
| SW219910-1 |
| UNII-181R97MR71 |
| W-5894 |
| Y1468 |
| ZINC38460704 |
US Patents and Regulatory Information for binimetinib
| 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 | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | 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 binimetinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1167390 | Start Trial |
| Taiwan | 201427956 | Start Trial |
| Japan | 5498546 | Start Trial |
| Taiwan | I343377 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for binimetinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1482932 | 14/2019 | Austria | Start Trial | PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924 |
| 1482932 | 2019C/510 | Belgium | Start Trial | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924 |
| 2470526 | C20190011 00282 | Estonia | Start Trial | PRODUCT NAME: ENKORAFENIIB;REG NO/DATE: EU/1/18/1314 24.09.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
