Mektovi is a drug owned by Array Biopharma Inc. It is protected by 11 US drug patents filed in 2018. Out of these, 8 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 18, 2033. Details of Mektovi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US8178693 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2023
(1 year, 4 months ago) |
Expired
|
| US7777050 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2025
(7 months from now) | Active |
| US9562016 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(9 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8193229 | Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2023
(1 year, 4 months ago) |
Expired
|
| US8513293 | Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal |
Mar, 2023
(1 year, 4 months ago) |
Expired
|
| US9593100 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(6 years from now) | Active |
| US10005761 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(6 years from now) | Active |
| US9850229 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(6 years from now) | Active |
| US9314464 | Compounds and compositions as protein kinase inhibitors |
Jul, 2031
(6 years from now) | Active |
| US9980944 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(9 years from now) | Active |
| US9598376 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Mektovi's patents.
Latest Legal Activities on Mektovi's Patents
Given below is the list of recent legal activities going on the following patents of Mektovi.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jul, 2024 | US9562016 |
| Expire Patent | 08 Jul, 2024 | US8193229 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed | 24 Jun, 2024 | US8178693 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 21 Jun, 2024 | US9593100 |
| Withdrawal of Application for PTE | 21 Jun, 2024 | US9314464 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 21 Jun, 2024 | US9314464 |
| Expire Patent | 17 Jun, 2024 | US8178693 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US8178693 |
| Withdrawal of Application for PTE | 25 Jan, 2024 | US8178693 |
| Interim Patent Term Extension Granted | 22 Jan, 2024 | US7777050 |
FDA has granted several exclusivities to Mektovi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mektovi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Mektovi.
Exclusivity Information
Mektovi holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Mektovi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 27, 2023 |
| Orphan Drug Exclusivity(ODE-194) | Jun 27, 2025 |
| New Indication(I-928) | Oct 11, 2026 |
Several oppositions have been filed on Mektovi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Mektovi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Mektovi patents.
Mektovi's oppositions filed in EPO
Mektovi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 19, 2018, by Generics [Uk] Limited (Trading As Mylan). This opposition was filed on patent number EP15177189A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15177189A | Apr, 2018 | Generics [UK] Limited (trading as Mylan) | Revoked |
US patents provide insights into the exclusivity only within the United States, but Mektovi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Mektovi's family patents as well as insights into ongoing legal events on those patents.
Mektovi's family patents
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Generic Launch
Generic Release Date:
Mektovi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 18, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mektovi Generics:
There are no approved generic versions for Mektovi as of now.
How can I launch a generic of Mektovi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Mektovi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Mektovi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Mektovi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg | 27 Jun, 2022 | 3 | 18 Oct, 2033 |
About Mektovi
Mektovi is a drug owned by Array Biopharma Inc. It is used for treating melanoma and non-small cell lung cancer in combination with encorafenib for patients with a BRAF mutation. Mektovi uses Binimetinib as an active ingredient. Mektovi was launched by Array Biopharma Inc in 2018.
Market Authorisation Date:
Mektovi was approved by FDA for market use on 27 June, 2018.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Mektovi is 27 June, 2018, its NCE-1 date is estimated to be 27 June, 2022
Active Ingredient:
Mektovi uses Binimetinib as the active ingredient. Check out other Drugs and Companies using Binimetinib ingredient
Treatment:
Mektovi is used for treating melanoma and non-small cell lung cancer in combination with encorafenib for patients with a BRAF mutation.
Dosage:
Mektovi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET | Prescription | ORAL |