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. Mektovi's patents have been open to challenges since 27 June, 2022. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9562016 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(7 years from now) | Active |
| US7777050 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2027
(5 months from now) | Active |
| US8178693 | N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2023
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9980944 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(7 years from now) | Active |
| US9598376 | Preparation of and formulation comprising a MEK inhibitor |
Oct, 2033
(7 years from now) | Active |
| US9314464 | Compounds and compositions as protein kinase inhibitors |
Jul, 2031
(4 years from now) | Active |
| US10005761 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(3 years from now) | Active |
| US9593100 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(3 years from now) | Active |
| US9850229 | Compounds and compositions as protein kinase inhibitors |
Aug, 2030
(3 years from now) | Active |
| US8513293 | Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal |
Mar, 2023
(3 years ago) |
Expired
|
| US8193229 | Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors |
Mar, 2023
(3 years ago) |
Expired
|
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.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| PTE Interim Patent Extension filed | 20 Dec, 2025 | US7777050 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Nov, 2025 | US10005761 |
| Withdrawal of Application for PTE | 03 Nov, 2025 | US8178693 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Oct, 2025 | US9980944 |
| Expire Patent | 22 Sep, 2025 | US8513293 |
| Notice of Final Determination -Election Required | 20 May, 2025 | US8178693 |
| Maintenance Fee Reminder Mailed | 07 Apr, 2025 | US8513293 |
| Interim Patent Term Extension Granted | 24 Feb, 2025 | US8178693 |
| Interim Patent Term Extension Granted | 24 Feb, 2025 | US7777050 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2025 | US9850229 |
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 2 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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Mektovi:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 26 Jun, 2025 | 18 Oct, 2033 | Less | |||
| 27 Jun, 2022 | 18 Oct, 2033 | Moderate |
Alternative Brands for Mektovi
Mektovi which is used for treating melanoma and non-small cell lung cancer in combination with encorafenib for patients with a BRAF mutation., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Array Biopharma Inc |
| |||
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 in 2018.
Approval Date:
Mektovi was approved by FDA for market use on 27 June, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |