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Last Updated: June 20, 2024

Details for New Drug Application (NDA): 210498


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NDA 210498 describes MEKTOVI, which is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the MEKTOVI profile page.

The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.
Summary for 210498
Tradename:MEKTOVI
Applicant:Array Biopharma Inc
Ingredient:binimetinib
Patents:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210498
Generic Entry Date for 210498*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

Suppliers and Packaging for NDA: 210498
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEKTOVI binimetinib TABLET;ORAL 210498 NDA Array BioPharma Inc. 70255-010 70255-010-02 1 BOTTLE in 1 CARTON (70255-010-02) / 180 TABLET, FILM COATED in 1 BOTTLE
MEKTOVI binimetinib TABLET;ORAL 210498 NDA Array BioPharma Inc. 70255-010 70255-010-03 90 TABLET, FILM COATED in 1 BOTTLE (70255-010-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Jun 27, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 11, 2026
Regulatory Exclusivity Use:ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Jun 27, 2025
Regulatory Exclusivity Use:ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Patent:⤷  Sign UpPatent Expiration:Aug 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

Expired US Patents for NDA 210498

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.