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 ninety-nine patent family members in forty-seven 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 have been five 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.

Indicators of Generic Entry

Summary for MEKINIST

International Patents:	199
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	92
Patent Applications:	3,919
Drug Prices:	Drug price information for MEKINIST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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					Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes					Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes
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					Y

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

Finland

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

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
European Patent Office	4159205	NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION)
Lithuania	4159217
Poland	2298768
Mexico	2012004413	COMBINACION. (COMBINATION.)
Hungary	E046139
Poland	4159205

Supplementary Protection Certificates for MEKINIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	1490063-3	Sweden		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
1761528	PA2014039	Lithuania		PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	300701	Netherlands		PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528	CA 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
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	CR 2014 00055	Denmark		PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140702

Market Dynamics and Financial Trajectory for MEKINIST (Trametinib)

Last updated: August 30, 2025

Introduction

MEKINIST (trametinib) is a targeted cancer therapy developed by Pfizer, primarily indicated for the treatment of BRAF V600E or V600K mutation-positive melanoma. Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, MEKINIST has become a cornerstone in the evolving landscape of targeted oncology treatments. Its market trajectory is influenced by a confluence of clinical innovation, regulatory shifts, competitive positioning, and broader trends in personalized medicine. This report offers a comprehensive analysis of MEKINIST's market dynamics and financial outlook, essential for stakeholders seeking strategic insight within the oncology therapeutics sector.

Market Overview and Therapeutic Landscape

Targeted Oncology Market Growth

The global oncology market has experienced exponential growth, driven by advances in molecular diagnostics and personalized therapy development. According to IQVIA, the oncology market is projected to reach approximately $231 billion by 2027, with targeted therapies accounting for a significant share. The demand for BRAF and MEK inhibitors like MEKINIST reflects the shift towards precise, mutation-driven treatments for melanoma and other cancers.

Indications and Expansion Potentials

Initial approval for MEKINIST targeted metastatic melanoma with BRAF V600 mutations. Subsequently, its indications expanded to include adjuvant therapy in combination with BRAF inhibitors (e.g., TAFINLAR/TAFIMILIS) and treatment of non-small cell lung cancer (NSCLC) with BRAF V600E mutations[1]. This expansion underscores a broader market opportunity, especially as testing for BRAF mutations becomes more routine.

Competitive Positioning

MEKINIST faces competition from several MEK inhibitors such as Cobimetinib (COTELLIC), Binimetinib (MEKTOVI), and emerging pipeline agents. The combination therapies, notably with BRAF inhibitors like TAFINLAR, have demonstrated superior efficacy over monotherapies, solidifying MEKINIST’s role within combination regimens. However, competition remains intense, necessitating continuous innovation and real-world evidence generation.

Market Drivers

Personalized Medicine and Biomarker Testing

The increasing adoption of genomic profiling for melanoma and other cancers augments the marketability of MEKINIST. As comprehensive mutation testing becomes standard, tailored prescriptions enhance treatment efficacy and patient outcomes. This trend favors drugs like MEKINIST, which are efficacious specifically for BRAF-mutated cancers.

Regulatory Advances and Approvals

Expedited pathways, including Fast Track and Breakthrough Therapy designations, have facilitated quicker access to MEKINIST for eligible patients. The FDA's recent approvals for combination treatments have further validated its therapeutic value and expanded its potential market.

Oncology Treatment Paradigm Shift

The paradigm shift towards targeted therapy over conventional chemotherapies enhances demand for molecularly targeted agents. MEKINIST benefits from the trend as clinicians prefer precision treatments with improved survival and reduced toxicity profiles.

Pipeline and Combination Strategies

Pfizer’s ongoing clinical trials explore MEKINIST in combination with immunotherapies or other targeted agents, potentially expanding its indications. Success in these trials could yield additional revenue streams and market penetration.

Market Challenges

Pricing and Reimbursement Pressures

As with many targeted therapies, MEKINIST faces scrutiny over high treatment costs. Payer negotiations, formulary placements, and value-based pricing models could impact revenues. Marrying cost-effectiveness with clinical benefits remains critical.

Resistance Mechanisms and Treatment Duration

Emerging evidence suggests eventual resistance to MEK inhibitors, necessitating combination regimens or novel agents. This may influence long-term treatment patterns and necessitate ongoing R&D investments.

Competition Landscape

With newer agents entering the market and combination regimens becoming standard, MEKINIST must adapt proactively. Patent expirations or biosimilar entries could further pressure pricing strategies.

Financial Trajectory Analysis

Revenue Outlook

Pfizer reported significant sales of MEKINIST, with global revenues exceeding $600 million in 2022[2]. Growth is driven by increased adoption in both European and Asian markets, as well as expanding indications. As insurance reimbursements improve and clinical guidelines endorse combination therapies, revenues are expected to remain robust.

Market Penetration and Geographic Expansion

Growth potential exists in emerging markets where molecular testing infrastructure investments are ongoing. Additionally, broader approval across Asia-Pacific regions and non-melanoma indications can catalyze revenue expansion.

Research and Development Investment Impact

Continued R&D efforts, especially in combination therapies and novel indications, require substantial investment but can translate into future market share gains. Pfizer’s strategic collaborations and licensing agreements bolster pipeline prospects.

Profitability and Cost Management

While patent protections sustain high margins, erosion due to generic competition and payer negotiations forecast a gradual decline in profitability over the next decade without innovative pipeline extensions.

Future Outlook and Strategic Considerations

Pipeline and Next-Generation Therapies

Investments in next-generation MEK inhibitors with improved efficacy and safety profiles are underway. Additionally, combination regimens with immunotherapies such as checkpoint inhibitors could redefine treatment algorithms.

Regulatory and Market Developments

Ongoing regulatory reviews for new indications, companion diagnostics approvals, and health policy shifts toward value-based care will shape MEKINIST's financial path.

Potential Market Expansion

Further exploration into rare cancers harboring BRAF mutations opens new therapies avenues. Strategic collaborations with diagnostic companies can accelerate precision medicine adoption, boosting market share.

Key Takeaways

• The global targeting of BRAF-mutated cancers sustains robust demand for MEKINIST, with growth driven by broader indications and molecular testing uptake.
• Competition from other MEK inhibitors and emerging therapies necessitates Pfizer’s focus on innovation, combination strategies, and market differentiation.
• Reimbursement landscapes and pricing pressures remain core considerations in maintaining profitability and market penetration.
• The integration of MEKINIST into combination regimens with immunotherapies offers significant upside potential, contingent on successful clinical trial outcomes.
• Geographic expansion, particularly in emerging markets, and pipeline development remain critical to securing long-term revenue growth.

FAQs

1. What are the primary indications for MEKINIST?
MEKINIST is approved for treating BRAF V600E or V600K mutation-positive melanoma, either alone or in combination with BRAF inhibitors; additionally, it has FDA approval for BRAF-mutant non-small cell lung cancer and has potential in other BRAF-driven tumors.

2. How does MEKINIST compare to its competitors?
While efficacious, MEKINIST’s market share faces competition from other MEK inhibitors like COTELLIC and MEKTOVI. Its combination regimens with BRAF inhibitors often demonstrate superior efficacy, positioning it favorably within combination therapies.

3. What factors could impact MEKINIST’s revenue in the future?
Patent expirations, generic competition, payer pressure, emerging resistance mechanisms, and regulatory changes can affect its financial performance.

4. Are there ongoing clinical trials that could expand MEKINIST’s uses?
Yes, Pfizer is exploring MEKINIST in combination with immunotherapies and in other BRAF-mutant cancers, which may lead to new approvals and market expansion.

5. What strategies can Pfizer implement to maximize MEKINIST’s market potential?
Strategic focus on pipeline innovation, expanding indications, enhancing diagnostic integration, and managing cost-effectiveness will be key to sustaining growth.

References

1. Pfizer. (2022). MEKINIST (trametinib) prescribing information.
2. IQVIA. (2022). Global Oncology Market Report, 2022-2027.