MEKTOVI Drug Patent Profile

When do Mektovi patents expire, and when can generic versions of Mektovi launch?

Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Mektovi

Mektovi was eligible for patent challenges on June 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (binimetinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MEKTOVI

US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEKTOVI

Paragraph IV (Patent) Challenges for MEKTOVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKTOVI	Tablets	binimetinib	45 mg	210498	1	2025-06-26
MEKTOVI	Tablets	binimetinib	15 mg	210498	3	2022-06-27

US Patents and Regulatory Information for MEKTOVI

MEKTOVI is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,562,016.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,980,944
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,850,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	7,777,050		Y	Y

International Patents for MEKTOVI

When does loss-of-exclusivity occur for MEKTOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Jordan

Poland

Portugal

Russian Federation

Slovenia

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MEKTOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	077975
Australia	2010286569
Brazil	112012004453

Supplementary Protection Certificates for MEKTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	648	Finland
2727918	201940012	Slovenia		PRODUCT NAME: COMBINATION OF BINIMETINIB AND ENCORAFENIB, EACH OF WHICH IS OPTIONAL IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314/001-002, EU/1/18/1315/001; DATE OF NATIONAL AUTHORISATION: 20180920; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2727918	2019C/509	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE

Mektovi (mektovi = relatlimab?) Investment Scenario and Patent/Market Fundamentals Analysis (US exclusivity, generic risk, and value-at-stake)

Last updated: July 9, 2026

Mektovi’s investment profile is defined by (1) FDA approval and labeling scope in metastatic melanoma, (2) how long the company holds enforceable US IP (patents and any regulatory exclusivities), and (3) whether competitors can enter via generic or biologic pathways during the protection window. The core commercial question is timing: when exclusivity ends and what remaining patent barriers prevent a low-cost “drop-in” alternative. The core legal question is breadth: how many distinct patent families cover the drug substance, specific compositions/formulations, and methods of use, and how consistently those families are expected to withstand generic or biosimilar-style challenges.

No reliable, complete dataset is available here to map Mektovi to its active ingredient, construct an Orange Book or Purple Book status view, identify all asserted/expired US patents, or tie that to FDA milestones and revenue exposure. Without those facts, producing a complete and accurate investment-and-IP fundamentals analysis would risk generating incorrect expiration dates, litigation conclusions, or generic entry scenarios.

What is Mektovi and what are the core investment drivers for sales growth in metastatic melanoma?

Featured snippet: Investment drivers for an oncology immunotherapy like Mektovi are label expansion in line-of-therapy, durability of clinical benefit versus standard-of-care, payer coverage and uptake, and the remaining duration of regulatory and patent exclusivity that protects pricing.

Which indication and line-of-therapy does Mektovi target?

• Investment relevance: market size and competitive intensity differ sharply by line (first-line vs later-line), biomarkers, and combination strategy.
• Signal to track: label language (overall survival or progression-free survival endpoints), allowable patient subgroups, and whether combinations are listed.

What pricing and access dynamics shape near-term revenue?

• Track: average sales price trajectory, payer formulary placement, and use of patient assistance programs.
• Competitive access risk: if a rival regimen is priced lower or wins formulary access, volume growth can slow even if clinical outcomes remain strong.

What is the competitive set for Mektovi in melanoma?

• Track: overlap with PD-1 inhibitors, CTLA-4 inhibitors, and combination regimens in metastatic melanoma.
• Track: “sequencing” decisions by oncology practices, which can shift share even with comparable efficacy.

What patents protect Mektovi in the US, and how strong is the patent estate?

Featured snippet: The strength of a patent estate is determined by the number of independent families (drug substance, formulations, and methods of use), how many have later expiration, and whether they are likely to be asserted and sustained in litigation.

How many patent families cover Mektovi’s key value elements?

Investment-grade mapping requires:

• Drug substance (active ingredient) composition of matter families.
• Formulation or dosage-form patents (if applicable).
• Method-of-use patents tied to the approved clinical regimen.
• Any manufacturing or process patents that can constrain “non-infringing” design-arounds.

What is the earliest likely US patent expiration date for Mektovi?

• Critical for investors: earliest date for potential generic “first filing” leverage and for any settlement leverage points.

What is the probability that each patent is litigated or challenged?

• High-value assessment depends on whether competitors commonly file at the edge of the window and whether patents are known to be vulnerable (e.g., predictable obviousness issues, claim scope overlap, or enablement disputes).

When does Mektovi lose exclusivity in the US: patents vs regulatory exclusivities?

Featured snippet: For an FDA-approved drug, exclusivity is usually a combination of patent expiration and any regulatory exclusivities (new chemical entity, new therapeutic biologic exclusivity, pediatric exclusivity, and orphan exclusivity if applicable).

Do any regulatory exclusivities apply to Mektovi?

To assess timing, you need the label’s exclusivity category:

• Small molecule exclusivity concepts do not map 1:1 to biologics.
• For biologics, the exclusivity framework depends on reference product determination and 351(k) pathway timing.

What is the exclusivity timeline investors should model?

A defensible model splits into:

• “Hard” IP expiry (patent expiration).
• “Procedural” entry timing (first possible application or challenge window).
• “Settlement” risk points (frequent in brand-generic negotiations).

What generic entry risks exist for Mektovi, and what would a “low-cost entry” scenario look like?

Featured snippet: Generic entry risk is driven by whether Mektovi is a small molecule or a biologic, the number of blocking patents, and how early challengers can file and then launch post-expiration.

If Mektovi is a small molecule: what Paragraph IV scenarios matter?

• Paragraph IV filing eligibility depends on Orange Book listings for the active ingredient and dosage forms.
• The most common risk scenario is earlier-than-expected erosion driven by narrow patent coverage or weak method-of-use blocking.

If Mektovi is a biologic: what biosimilar risk matters?

• Biosimilar risk is driven by:
  • the existence of biologic product-specific patents,
  • whether the product is protected under patents that cover structure, formulation, and functional claims,
  • and whether litigation settlements enable earlier launches.

What is the Orange Book status of Mektovi, and which listed patents block generic approval?

Featured snippet: Orange Book status determines what a generic applicant must address via certification (often Paragraph IV) to overcome listed patents.

What dosage forms are listed, and which patents tie to each?

Key investment relevance:

• If multiple strengths/dosage forms are listed with distinct patents, generic launch timing can stagger.
• If patents are tied to a single dosage form, competitors can choose the most profitable strength to launch first.

Which patents are likely to be asserted first?

Investors should focus on:

• The most recent patents with the latest expiration that are commonly asserted.
• Patents that are product-defining versus broad and potentially design-aroundable.

How do Mektovi patent protections compare with competing melanoma therapies?

Featured snippet: Relative IP strength often predicts relative pricing power and durability of revenue. The comparison is between (1) time-to-expiration, (2) number of blocking patents, and (3) likelihood of successful launch challenges.

Brand-to-brand comparison axes

• Label overlap (same regimen/line/patient subgroup).
• IP overlap breadth (compositions vs methods of use).
• Litigation intensity in the category (historical behavior by competitors).

What patent litigation affects Mektovi, including settlements and court outcomes?

Featured snippet: Patent litigation impacts the investment timeline by shifting the effective launch date through injunctions, stays, and settlements.

What court venues and decisions drive entry timing?

• Federal district court decisions can block launch pending appeals.
• Settlement agreements can create fixed launch dates or “carve-outs” based on patent scope.

How do settlements typically work in this category?

Common patterns include:

• Reverse payment-style settlements (historically common in small molecule generic disputes).
• Biologic settlements based on stipulated launch dates and non-infringement positions.

What FDA regulatory status milestones define the remaining Mektovi runway?

Featured snippet: The FDA status determines whether there is additional exclusivity runway via supplements or label expansions and whether a competitor can route through the 505(b)(2) or biosimilar frameworks.

Key milestones to map (investor checklist)

• Original approval date.
• Major label supplement dates.
• Pediatric or other regulatory exclusivity events (if any).
• Reference product designation milestones (if biologic).

What formulations are protected for Mektovi, and how do formulation patents change generic design-around risk?

Featured snippet: Formulation and dosage-form patents can extend protection even when core composition-of-matter is weaker or expires earlier.

What dosage forms matter to competition?

• If only one dosage form is critical commercially, “strength-specific” patent listings can determine which generic/biosimilar can enter first.

What design-around options exist?

• Formulation patents can still be bypassed if claims are narrow or if competitors can demonstrate bioequivalence under different manufacturing/formulation approaches.

Which companies are positioned to challenge Mektovi, and what is their launch track record?

Featured snippet: The probability of a fast erosion depends on challengers’ historical filing behavior, litigation posture, and capability to execute manufacturing at scale.

Challengers to monitor by behavior

• Companies that repeatedly file at the edge of exclusivity are often early-launch candidates.
• Companies with strong biosimilar development pipelines are high-impact for biologics.

How big is the revenue exposure from Mektovi in the next 3 to 7 years, and what drives upside/downside?

Featured snippet: Revenue exposure is a function of (1) label size and durability of clinical benefit, (2) competitive penetration, and (3) IP and regulatory timelines that determine cost-down entry.

What drives downside?

• Faster-than-expected erosion due to successful entry challenges.
• Slower uptake from payer restrictions or competitor share gain.
• Adverse safety signals or loss of guideline position.

What drives upside?

• Expanded label indication and combination approvals.
• Stronger-than-expected patient retention and line-of-therapy capture.
• Durable pricing power through sustained IP blocks.

Key Takeaways

• Mektovi’s investment case hinges on enforceable US IP duration (patents plus any regulatory exclusivities) and the number of independent blocking families covering drug substance, formulations, and methods of use.
• Generic/biosimilar risk is timeline-driven: investors should model earliest challenge/filing leverage points, then the effective launch date after litigation stays or settlements.
• Competitive share is driven by label scope and sequencing, not only efficacy headlines; payer access and formulary placement determine whether clinical differentiation translates into durable revenue.
• Litigation and settlements in the category can shift effective exclusivity and materially change revenue timing.

FAQs

1. What is Mektovi’s active ingredient and is it a small molecule or a biologic for exclusivity modeling?
2. How do I map Mektovi’s US patent estate to Orange Book or Purple Book listings by dosage form?
3. What is the earliest date a challenger could file (or re-file) to target Mektovi exclusivity?
4. Which types of patents most commonly block generic or biosimilar entry for oncology products like Mektovi?
5. How should investors model revenue impact under a “delayed entry vs early entry” scenario for Mektovi?

References

(No sources cited because Mektovi-specific patent, FDA exclusivity, Orange Book/Purple Book, litigation, and corporate commercial data were not provided in the prompt.)