MEKINIST Drug Patent Profile

When do Mekinist patents expire, and what generic alternatives are available?

Mekinist is a drug marketed by Novartis and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-nine patent family members in forty-six countries.

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mekinist

Mekinist was eligible for patent challenges on May 29, 2017.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for MEKINIST

International Patents:	169
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	92
Patent Applications:	2,448
Drug Prices:	Drug price information for MEKINIST
What excipients (inactive ingredients) are in MEKINIST?	MEKINIST excipients list
DailyMed Link:	MEKINIST at DailyMed

See drug prices for MEKINIST

Recent Clinical Trials for MEKINIST

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

Sponsor	Phase
Erasca, Inc.	Phase 1
Peter Hosein, MD	Phase 1
University of Miami Sylvester Comprehensive Cancer Center	Phase 1

See all MEKINIST clinical trials

Pharmacology for MEKINIST

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for MEKINIST

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKINIST	Tablets	trametinib dimethyl sulfoxide	0.5 mg and 2 mg	204114	1	2023-09-28

US Patents and Regulatory Information for MEKINIST

MEKINIST is protected by nine US patents and eleven FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	9,155,706*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	9,155,706*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	8,952,018*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes

International Patents for MEKINIST

When does loss-of-exclusivity occur for MEKINIST?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 MEKINIST around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1206642
Japan	5421974
Japan	2014510704
Peru	20121093	COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
South Korea	102134585
Spain	2745479
Taiwan	I505828

Supplementary Protection Certificates for MEKINIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	122014000102	Germany		PRODUCT NAME: TRAMETINIB, GEGEBENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	2014/063	Ireland		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702
1761528	205 5032-2014	Slovakia		PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
1761528	68/2014	Austria		PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528	PA2014039	Lithuania		PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	PA2014039,C1761528	Lithuania		PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	SPC/GB14/081	United Kingdom		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702

Market Dynamics and Financial Trajectory for MEKINIST

Introduction to MEKINIST

MEKINIST, also known as trametinib, is a MEK inhibitor developed by GlaxoSmithKline and later acquired by Novartis. It is a crucial component in the treatment of various cancers, including melanoma, non-small cell lung cancer (NSCLC), and thyroid cancer. Here, we delve into the market dynamics and financial trajectory of MEKINIST.

Market Size and Growth

The global MEK inhibitors market, led by MEKINIST, is experiencing significant growth. As of 2023, the MEK inhibitors market was valued at USD 2.1 billion and is projected to reach USD 6.3 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 12% during the forecast period from 2024 to 2033[1].

Market Share and Dominance

MEKINIST commands a substantial market share within the MEK inhibitors segment. It holds approximately 40% of the market share, making it the dominant force in this therapeutic category. Other MEK inhibitors such as COTELLIC and MEKTOVI also contribute to the market, but MEKINIST remains the top contender[1].

End-User Analysis

Clinics are the primary end-users of MEKINIST, accounting for more than 50% of the market share. This dominance underscores the pivotal role clinics play in the adoption and utilization of MEK inhibitor therapies within the healthcare landscape[1].

Application and Therapeutic Use

MEKINIST is widely used in various therapeutic conditions, including melanoma, NSCLC, and thyroid cancer. It is effective both as a monotherapy and in combination with other treatments. For instance, MEKINIST is used in combination with Tafinlar (dabrafenib) for the treatment of melanoma with BRAF V600 mutations. Its significant utilization rate in combating NSCLC further solidifies its market position[1][3].

Regional Analysis

The MEK inhibitors market, led by MEKINIST, is geographically dominated by North America, which holds a 45% market share. This dominance is driven by extensive research activities, high prevalence of cancer cases, and increasing awareness among the population. Europe and the Asia Pacific also show significant growth potential, particularly in economies like India and China where the prevalence of various types of cancer is increasing[1][3].

Financial Performance

The financial performance of MEKINIST is robust and continues to grow. In the third quarter of 2023, the combined sales of Tafinlar and MEKINIST reached USD 486 million, with a 7% increase in constant currencies, driven mainly by strong performance in the US and emerging markets[5].

Sales and Revenue

MEKINIST, along with Tafinlar, has consistently shown strong sales growth. For example, in 2018, the combined sales of Tafinlar and MEKINIST were USD 291 million, with a 33% increase in constant currencies[2].

Operating Income and Net Sales

The overall financial health of Novartis, the company behind MEKINIST, reflects the drug's contribution. In 2023, Novartis reported net sales of USD 45.4 billion, driven by volume growth and partly offset by price erosion and generic competition. The core operating income grew by 18% in constant currencies, with a significant contribution from oncology products like MEKINIST[5].

Driving Factors

Increasing Prevalence of Cancer

The rising incidence of cancer globally is a significant driver for the MEK inhibitors market. Cancer cases are expected to reach over 27 million new cases annually by 2040, highlighting the urgent need for effective treatments like MEKINIST[1].

Research and Development

Increasing investments in research and development by major key players such as Pfizer, CStone Therapeutics, Bristol Myers Squibb, Roche, and Novartis are propelling the growth of the MEK inhibitors market. These investments include clinical trials and the development of new combinational therapies to overcome resistance to MEK inhibitors[3][4].

Strategic Collaborations

Companies are adopting strategies such as agreements, collaborations, production launches, and mergers and acquisitions to stay at the forefront of the market. These strategies lead to newer products, technological advancements, and regulatory support, ultimately driving customer satisfaction and market growth[3][4].

Challenges and Limitations

High Cost of Therapy

One of the significant barriers to the growth of the MEK inhibitors market is the high cost of therapy, which increases the financial burden on patients and makes it unaffordable for a large population[3][4].

Development of Resistance

The development of resistance to MEK inhibitors is another challenge. To address this, researchers are evaluating several combinational therapies that are expected to gain approval during the forecast period[3][4].

Future Outlook

The global MEK inhibitors market, led by MEKINIST, is poised for significant growth. The market is expected to surpass USD 3 billion by 2026, driven by increasing cancer incidence, robust pipeline development, and strategic collaborations among key players[3][4].

Key Takeaways

• Market Dominance: MEKINIST holds a 40% market share in the MEK inhibitors segment.
• Financial Growth: Combined sales of Tafinlar and MEKINIST show consistent growth, contributing to Novartis's overall financial health.
• Therapeutic Use: MEKINIST is widely used in treating melanoma, NSCLC, and thyroid cancer.
• Regional Dominance: North America leads the market, with significant growth potential in Europe and the Asia Pacific.
• Driving Factors: Increasing cancer prevalence, R&D investments, and strategic collaborations drive market growth.
• Challenges: High therapy costs and resistance development are key challenges.

FAQs

Q: What is the current market value of the MEK inhibitors market?

The MEK inhibitors market was valued at USD 2.1 billion in 2023 and is expected to reach USD 6.3 billion by 2033[1].

Q: Which region dominates the MEK inhibitors market?

North America dominates the MEK inhibitors market with a 45% share, driven by extensive research activities and high cancer prevalence[1].

Q: What are the primary therapeutic uses of MEKINIST?

MEKINIST is used in treating melanoma, non-small cell lung cancer (NSCLC), and thyroid cancer, both as a monotherapy and in combination with other treatments[1][3].

Q: What are the key challenges facing the MEK inhibitors market?

The high cost of therapy and the development of resistance to MEK inhibitors are significant challenges to market growth[3][4].

Q: Which companies are key players in the MEK inhibitors market?

Key players include Pfizer, CStone Therapeutics, NFlection, Bristol Myers Squibb, Roche, and Novartis[3][4].

Sources

1. MarketResearch.biz: MEK Inhibitors Market Size, Share, Growth | CAGR of 12.0%[1].
2. Novartis: Novartis delivered strong growth and innovation during the third quarter[2].
3. Biospace: MEK Inhibitors Market Size Drugs Sales Forecast Clinical Trials Research Companies Report 2026[3].
4. GlobeNewswire: MEK Inhibitors Market Size Drugs Sales Forecast Clinical Trials Research Companies Report 2026[4].
5. Novartis: Novartis Financial Results Q4 2023 – English[5].