MEKTOVI Drug Patent Profile

Which patents cover Mektovi, and what generic alternatives are available?

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

This drug has two hundred and thirty-one patent family members in fifty-five countries.

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 three 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

International Patents:	231
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	35
Patent Applications:	1,226
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEKTOVI
What excipients (inactive ingredients) are in MEKTOVI?	MEKTOVI excipients list
DailyMed Link:	MEKTOVI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MEKTOVI

Constraining patent/regulatory exclusivity:

9,562,016

NDA:

210498

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.

Recent Clinical Trials for MEKTOVI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 2
Merck Sharpe & Dohme LLC	Phase 2
National Cancer Institute, France	Phase 3

See all MEKTOVI clinical trials

Paragraph IV (Patent) Challenges for MEKTOVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 two FDA Regulatory Exclusivities.

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
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	10,005,761

Expired US Patents for MEKTOVI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	7,777,050
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,178,693
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,513,293
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,193,229

EU/EMA Drug Approvals for MEKTOVI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Mektovi	binimetinib	EMEA/H/C/004579 Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	Authorised	no	no	no	2018-09-20

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
Australia	2010286569	Compounds and compositions as protein kinase inhibitors
Cuba	24110	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA
Guatemala	201200053	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA
Hungary	E032847

Supplementary Protection Certificates for MEKTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	14/2019	Austria		PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924
2727918	16/2019	Austria		PRODUCT NAME: KOMBINATION AUS BINIMETINIB UND ENCORAFENIB, JEWEILS IN ALLEN FORMEN EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/18/1314 EU/1/18/1315 (MITTEILUNG) 20180924
1482932	648	Finland
1482932	CA 2019 00011	Denmark		PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924

Market Dynamics and Financial Trajectory for Mektovi

Introduction to Mektovi

Mektovi, also known as binimetinib, is a MEK inhibitor that has recently entered the market and has shown promising results in the treatment of various types of cancer. Here, we will delve into the market dynamics and financial trajectory of Mektovi, highlighting its current status, future prospects, and the factors influencing its market performance.

Approval and Indications

Mektovi was approved by the FDA in 2018 for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with the BRAF inhibitor encorafenib (Braftovi)[1][3][4].

Market Performance

Current Market Share

Mektovi, along with other MEK inhibitors like Mekinist (trametinib), Cotellic (cobimetinib), and Koselugo (selumetinib), has contributed significantly to the MEK inhibitors market. The global MEK inhibitors market is projected to grow substantially, with Mektovi playing a crucial role due to its high response rates among patients[1][3].

Revenue and Sales

The MEK inhibitors market, including Mektovi, is expected to reach over USD 3 billion by 2026. Mektovi's sales have been robust, particularly when used in combination with other targeted therapies. The drug's performance is part of the broader trend where MEK inhibitors are gaining traction as standard treatments for advanced-stage cancers[1][4].

Clinical Trials and Future Prospects

Ongoing Clinical Trials

Mektovi is currently involved in several clinical trials evaluating its efficacy in treating various types of cancer, including ovarian cancer, myeloma, biliary tract cancer, and other solid tumors. For instance, Mektovi is in phase-III clinical trials for ovarian cancer, which is expected to expand its indications and boost market growth[1].

Combination Therapies

The use of Mektovi in combination with other chemotherapeutic agents and immune checkpoint inhibitors is a significant area of research. These combination therapies are expected to enhance the drug's efficacy against the multifactorial nature of cancer, thereby driving its market growth[1].

Key Drivers of Market Growth

Increased Spending on Cancer Research

The global MEK inhibitors market, including Mektovi, is benefiting from increased spending on cancer research and drug development. Governments and private entities are investing heavily in cancer-related research, which has led to significant advancements in targeted therapies like MEK inhibitors[3].

Use of Protein Biomarkers

The use of protein biomarkers, particularly in the diagnosis and treatment of non-small-cell lung carcinoma (NSCLC), has been a key driver for the MEK inhibitors market. Mektovi's high target affinity and specificity make it an attractive option for treating NSCLC and other cancers[4].

Collaborations and Partnerships

Companies like Array BioPharma, which developed Mektovi, have been involved in strategic acquisitions and partnerships. For example, Pfizer's acquisition of Array BioPharma in 2019 has provided additional resources and expertise to further develop and market Mektovi[5].

Challenges and Limitations

Development of Resistance

One of the major challenges facing Mektovi and other MEK inhibitors is the development of resistance to these drugs after 1-2 years of therapy. This resistance limits the long-term efficacy of the treatment. However, researchers are working on next-generation MEK inhibitors that aim to overcome this resistance[1].

Regional Market Dynamics

North America

North America, particularly the US, has been the leading contributor to the MEK inhibitors market, including Mektovi. The region's well-developed technology, large patient base, and significant investments in the healthcare sector have fueled the growth of MEK inhibitors[1].

Europe

Europe also accounts for a significant share of the MEK inhibitors market, driven by high cancer prevalence, increased healthcare expenditure, and rising government initiatives in cancer research[1].

Financial Trajectory

Revenue Growth

The revenue from Mektovi is expected to grow significantly over the forecast period, driven by its expanding indications and the increasing adoption of MEK inhibitors in cancer treatment. The global MEK inhibitors market is projected to grow at a CAGR of over 8% during the forecast period[1][4].

Impact of Acquisitions

Pfizer's acquisition of Array BioPharma has provided a financial boost to the development and marketing of Mektovi. The transaction, valued at approximately $11.4 billion, is expected to be accretive to Pfizer’s earnings beginning in 2022, with additional growth anticipated thereafter[5].

Key Takeaways

• Market Growth: Mektovi is part of a growing MEK inhibitors market, expected to reach over USD 3 billion by 2026.
• Clinical Trials: Ongoing clinical trials are evaluating Mektovi's efficacy in various cancers, including ovarian cancer.
• Combination Therapies: Mektovi's use in combination with other therapies is expected to enhance its efficacy.
• Challenges: Development of resistance is a major challenge, but next-generation MEK inhibitors are being developed to address this.
• Regional Dynamics: North America and Europe are key regions driving the market growth.

FAQs

1. What is Mektovi used for? Mektovi (binimetinib) is used for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with the BRAF inhibitor encorafenib (Braftovi).

2. What are the current clinical trials for Mektovi? Mektovi is currently in phase-III clinical trials for ovarian cancer and is being evaluated for other cancers such as myeloma, biliary tract cancer, and other solid tumors.

3. How does Mektovi work? Mektovi acts as a MEK inhibitor, directly hindering the activity of the MEK enzyme and helping to decrease tumor growth.

4. What are the challenges facing Mektovi? One of the major challenges is the development of resistance to the drug after 1-2 years of therapy, but researchers are working on next-generation MEK inhibitors to overcome this.

5. Who acquired Array BioPharma, the developer of Mektovi? Pfizer acquired Array BioPharma in 2019 for approximately $11.4 billion.

Sources

1. BioSpace - MEK Inhibitors Clinical Trials Market Approval Insight 2026
2. Pfizer Reports First-Quarter 2023 Results
3. BioSpace - MEK Inhibitors Market Demand and Growth Opportunity
4. GlobeNewswire - MEK Inhibitors: Worldwide Markets to 2023
5. Pfizer - Pfizer to Acquire Array BioPharma