COTELLIC Drug Patent Profile

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

Cotellic is a drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and ninety-seven patent family members in forty-four countries.

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

DrugPatentWatch^® Generic Entry Outlook for Cotellic

Cotellic was eligible for patent challenges on November 10, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for COTELLIC

International Patents:	197
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	35
Drug Prices:	Drug price information for COTELLIC
What excipients (inactive ingredients) are in COTELLIC?	COTELLIC excipients list
DailyMed Link:	COTELLIC at DailyMed

See drug prices for COTELLIC

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

NDA:

206192

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 COTELLIC

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

Sponsor	Phase
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	Phase 2/Phase 3
University of Birmingham	Phase 2/Phase 3

See all COTELLIC clinical trials

Pharmacology for COTELLIC

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

US Patents and Regulatory Information for COTELLIC

COTELLIC is protected by seven US patents and four FDA Regulatory Exclusivities.

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
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes					Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes					Y

International Patents for COTELLIC

When does loss-of-exclusivity occur for COTELLIC?

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

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Taiwan

Ukraine

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 COTELLIC around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2017016163
Hong Kong	1206605
Japan	7232284

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	C201630028	Spain		PRODUCT NAME: COBIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1048; DATE OF AUTHORISATION: 20151120; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1048; DATE OF FIRST AUTHORISATION IN EEA: 20151120
1934174	1691019-2	Sweden		PRODUCT NAME: COBIMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE, IN PARTICULAR COBIMETINIB HEMIFUMARATE; EU/1/15/1048 2015-11-24
1934174	2016/022	Ireland		PRODUCT NAME: COBIMETINIB, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES, IN PARTICULAR COBIMETINIB HEMIFUMARATE.; REGISTRATION NO/DATE: EU/1/15/1048/001 20151120

Market Dynamics and Financial Trajectory for Cotellic (Cobimetinib)

Last updated: July 27, 2025

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Introduction

Cotellic (generic name: cobimetinib) is an orally bioavailable MEK inhibitor developed by Genentech and Roche, primarily prescribed for the treatment of BRAF-mutated melanoma. Since receiving FDA approval in 2015, Cotellic has occupied a significant niche within targeted cancer therapies, driven by its mechanism of action and clinical efficacy. This analysis examines the evolving market dynamics and financial prospects surrounding Cotellic, considering competitive landscape, regulatory environment, and emerging treatment paradigms.

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Market Overview: Cotellic and Its Therapeutic Segment

Cotellic functions by inhibiting MEK1 and MEK2, key components in the MAPK/ERK pathway, which is hyperactivated in melanoma with BRAF V600 mutations. The drug is most often combined with BRAF inhibitors such as vemurafenib or encorafenib to improve clinical outcomes. The combination therapy has demonstrated significant survival benefits, establishing Cotellic as a cornerstone in metastatic melanoma management.

The global melanoma therapeutic market was valued at approximately $1.3 billion in 2022 and is projected to grow at a CAGR of roughly 8-10% over the next five years [1]. The integration of targeted therapies like Cotellic has elevated treatment standards, contributing to market expansion.

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Market Dynamics Influencing Cotellic

1. Clinical Efficacy and Label Expansion

Cotellic's approval in combination with BRAF inhibitors has been bolstered by pivotal trials such as the coBRIM study, which reported improved progression-free survival (PFS) and overall response rates (ORR). Ongoing clinical trials are exploring Cotellic's efficacy in other tumors, including colorectal and certain NSCLCs, potentially broadening its indications. Laboratory evidence suggests synergy with immune checkpoint inhibitors, paving the way for combination regimens that could further enhance market penetration.

2. Competitive Landscape

Cotellic faces competition from several agents within the targeted melanoma domain, including:

• Encorafenib (Braftovi): Approved with binimetinib (MEK inhibitor) and also partnered with BRAF inhibitors.
• Dabrafenib (Tafinlar): BRAF inhibitor, often combined with trametinib (MEK inhibitor).
• Other MEK inhibitors: Trametinib (GSK), binimetinib (Braftovo), and recently emerging agents with better tolerability profiles.

The competitive advantage of Cotellic resides in its proven efficacy and manageable adverse events, but market share is sensitive to price, therapy duration, and emerging combination strategies.

3. Regulatory and Patent Considerations

Cotellic's patent exclusivity is expected to extend until 2026-2028, with orphan drug status and supplemental approvals potentially prolonging market dominance. However, biosimilar and generic competition remains a long-term concern, notably after patent expiration.

4. Pricing and Reimbursement Environment

The high cost of targeted therapies constrains market growth in certain regions. Reimbursement negotiations in the US and Europe influence access, while value-based pricing models may impact revenue streams. Price discounts and patient assistance programs are common strategies to optimize uptake.

5. Emerging Treatment Modalities

The advent of immuno-oncology agents, such as anti-PD-1 therapies (nivolumab, pembrolizumab), has transformed melanoma treatment. The potential combination of Cotellic with immunotherapies is under investigation, promising expanded market share but also intensifying competition and clinical development costs.

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Financial Trajectory Projections

Historical Performance

Since its launch, Cotellic's sales have grown steadily, reaching approximately $370 million in 2022 globally, primarily driven by sales in the US, Europe, and Japan. The drug contributes significantly to Roche's oncology portfolio revenue, with primary sales derived from combination therapy regimens.

Forecasting Future Revenue

Factors influencing future financial trajectory include:

• Patent and exclusivity extensions: Protected revenues until at least 2026.
• Pipeline developments: Additional indications might boost sales by 10-20% per annum, especially if approvals in other tumor types materialize.
• Market penetration: Expansion into frontline metastatic melanoma treatment, supported by ongoing Phase III trials, could increase usage.
• Pricing Strategies: Maintaining premium pricing, while balancing reimbursement constraints, is vital; price erosion could impact margins after patent expiry.

Analysts project that Cotellic's global sales could reach $600-800 million over the next five years, assuming successful expansion and continued market penetration, with peak sales potentially exceeding $1 billion if new indications and combination therapies succeed [2].

Impact of Biosimilars/Post-Patent Competition

Post-2026, the entry of biosimilars and generics could dramatically reduce pricing and revenue, necessitating strategic innovation and pipeline diversification to sustain financial health.

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Market Challenges and Opportunities

Challenges	Opportunities
Patent expiry and generic competition	Development of next-generation MEK inhibitors with improved safety profiles
Competition from immunotherapies	Combination regimens with immune checkpoint inhibitors
Pricing pressures and reimbursement hurdles	Tailored, value-based pricing models
Limited indications outside melanoma	Expanded approvals in other BRAF-mutant cancers

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Strategic Outlook for Stakeholders

• Pharmaceutical companies should focus on clinical trials exploring combinatorial regimens, particularly with immune therapies.
• Investors should monitor patent timelines and pipeline developments to evaluate long-term revenues.
• Healthcare payers need to negotiate pricing agreements that balance access with cost containment.
• Regulatory agencies influence market dynamics through approval policies for new indications and biosimilar entry pathways.

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Key Takeaways

• Market Dynamics: Cotellic benefits from a well-established niche within BRAF-mutant melanoma therapy, but faces growing competition and reimbursement challenges. Clinical trials exploring broader indications and combination therapies could expand its market footprint.
• Financial Trajectory: Steady growth to potentially $600-800 million annually over the next five years hinges on expanding indications, clinical trial success, and market access strategies. Patent expiration after 2026 poses a threat, advocating for pipeline diversification.
• Opportunities and Risks: Strategic investments in combination therapies and new indications can sustain revenue streams, but generic entry poses long-term risks.
• Strategic Recommendations: Stakeholders should prioritize clinical innovation, optimize pricing, and prepare for post-patent market shifts to maintain competitive advantage.

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FAQs

1. What is Cotellic primarily approved for?
   Cotellic is approved for use in combination with vemurafenib or encorafenib for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.

2. How does Cotellic compare with other MEK inhibitors?
   Cotellic has demonstrated comparable efficacy and a manageable safety profile to other MEK inhibitors, with its combination regimens showing notable survival benefits.

3. What are the prospects for Cotellic outside melanoma?
   While currently approved for melanoma, ongoing research aims to explore Cotellic in colorectal and non-small cell lung cancers with BRAF mutations, which could diversify its market.

4. When will patent expiration impact Cotellic’s market presence?
   Patent exclusivity is expected to expire around 2026–2028, after which biosimilars and generics could erode its market share and revenue.

5. What strategies can sustain Cotellic’s market relevance post-patent?
   Developing new indications, enhancing combination regimens, and investing in next-generation MEK inhibitors are key strategies to prolong market presence.

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References

[1] Market Research Future, "Global Melanoma Therapeutics Market," 2022.
[2] EvaluatePharma, "Pharmaceutical Sales Forecast 2023–2028."