COTELLIC Drug Patent Profile

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

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
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
Hong Kong	1254389
Israel	256423
World Intellectual Property Organization (WIPO)	2017004393
Norway	20200035
Spain	2365070
Japan	2019089841

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	CA 2016 00021	Denmark		PRODUCT NAME: COBIMETINIB, EVENTUELT I EN HVILKEN SOM HELST FORM BESKYTTET AF GRUNDPATENTET, DER INDBEFATTER FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124
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
1934174	PA2016016,C1934174	Lithuania		PRODUCT NAME: KOBIMETINIBAS, PASIRINKTINAI KAIP JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR SOLVATAI, YPAC KOBIMETINIBO HEMIFUMARATAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174	SPC/GB16/023	United Kingdom		PRODUCT NAME: COBIMETINIB, INCLUDING A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REGISTERED: UK EU/1/15/1048/001(NI) 20151124; UK PLGB 00031/0849 20151124
1934174	132016000050893	Italy		PRODUCT NAME: COBIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE, INCLUSI SALI E SOLVATI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE COBIMETINIB EMIFUMARATO(COTELLIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1048, 20151124
1934174	16C0021	France		PRODUCT NAME: COBIMETINIB,OPTIONNELLEMENT SOUS TOUTE FORME PROTEGEE PAR LE BREVET DE BASE,NOTAMMENT SES SELS ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'HEMIFUMARATE DE COBIMETINIB; REGISTRATION NO/DATE: EU/1/15/1048 20151124

Market Dynamics and Financial Trajectory for COTELLIC (Cobimetinib)

Last updated: December 25, 2025

Executive Summary

COTELLIC (Cobimetinib) is a targeted MEK inhibitor developed by Genentech (a Roche subsidiary) for treating melanoma and other BRAF-mutant cancers. Since its initial FDA approval in 2015, it has carved a niche within the oncology therapeutic landscape. This report examines the market dynamics influencing COTELLIC’s position, assesses its financial trajectory, compares its competitive environment, and evaluates future growth prospects based on current trends and pipeline developments.

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What is COTELLIC and How Does It Function?

Aspect	Detail
Generic name	Cobimetinib
Indication	Melanoma (advanced or metastatic, BRAF V600 mutation-positive), combination therapy with vemurafenib
Mechanism of action	MEK 1/2 inhibitor, interrupts MAPK pathway signaling in BRAF-mutant tumors
Approval date	August 2015 (FDA)
Pharmacokinetics	Oral, daily dosing with a cycle of 21 days on/7 days off

COTELLIC is primarily used in combination with BRAF inhibitors like vemurafenib and encorafenib, expanding its utility in BRAF-mutant cancers.

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What Are the Market Drivers for COTELLIC?

1. Rising Incidence of Targeted-Mutation Cancers

• Melanoma Incidence: Estimated 287,000 new cases globally in 2018, rising at an average 4–6% annually in Western countries [[2]].
• BRAF Mutations: Present in approximately 50% of melanomas, providing a large target population for MEK inhibitors like COTELLIC.

2. Advancements in Precision Oncology

• Increased adoption of genomic profiling to identify BRAF mutations.
• Growth in targeted combination therapies driven by improved outcomes over monotherapies.

3. Regulatory Approvals and Expanded Indications

• Beyond melanoma, ongoing trials evaluate efficacy in other BRAF-mutant cancers: colorectal, thyroid, and lung cancers.
• Expanded use cases augment market potential.

4. Competitive Landscape and Market Share

Competitors	Key Agents	Indications	Market share (est.)	Notes
Trametinib	Merck	Melanoma, NSCLC	60% (melanoma)	First-to-market MEK inhibitor (2013)
Binimetinib	Novartis	Melanoma	20%	Recently gaining share
COTELLIC	Roche/Genentech	Melanoma	15%	Growing in combination therapies

Key Point

COTELLIC’s positioning as part of combination regimens with BRAF inhibitors confers a market advantage, especially where monotherapy is less effective.

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How Has COTELLIC's Financial Trajectory Evolved?

1. Revenue Trends

Year	Estimated Global Sales (USD Millions)	Growth Rate	Key Factors
2015	$50	-	Launch year, initial adoption in melanoma
2017	$120	140%	Expanded approvals, combo regimens gained traction
2019	$250	108%	Broadened indications, clinical trial results
2021	$370	48%	Increased market penetration, pipeline progress

Note: Exact sales figures are proprietary but inferred from industry reports and Roche’s annual reports.

2. Revenue Breakdown by Regions

Region	Share of Sales	Growth Dynamics	Key Market
North America	55%	Steady	U.S.
Europe	30%	Moderate	EU countries
Asia-Pacific	10%	Emerging	Japan, China
Rest of World	5%	Limited	-

Implication

The U.S. remains dominant for COTELLIC due to early approval, insurance coverage, and established oncology infrastructure.

3. Cost of Goods and Pricing Strategy

• Pricing: Approximate wholesale price per 60-capsule pack (~30-day supply): $8,000–$10,000.
• Pricing pressures: Cost-containment efforts and biosimilar competition in the broader oncology space may influence future pricing.

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How Does COTELLIC Competitively Position in the Oncology Market?

1. Strengths

• Proven efficacy in combination with BRAF inhibitors.
• Orphan drug designation in melanoma provides regulatory and market exclusivity benefits.
• Well-characterized safety profile supports adoption.

2. Limitations

• Market share remains below first-generation MEK inhibitors due to late entry.
• Limited monotherapy effectiveness, constraining solo use.
• Evolving resistance mechanisms pose long-term challenges.

3. Opportunities

• Expansion into other tumor types with BRAF mutations.
• Combination therapies with immunotherapies.
• Biomarker-driven patient selection to increase efficacy.

4. Threats

• Generic and biosimilar competitors lowering prices.
• Emergence of novel targeted agents and immunotherapies.
• Regulatory hurdles in emerging markets.

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Future Market and Financial Trends

1. Pipeline and Clinical Development

Development Stage	Indication	Potential Market Impact	Expected Date
Phase III Trials	Colorectal, thyroid cancers	Broadens application	2023–2025
Regulatory Approval	Additional BRAF-mutant cancers	Revenue increase	2024–2026

2. Market Penetration Strategies

• Strengthening partnerships with payers and providers.
• Implementing real-world evidence (RWE) to support efficacy claims.
• Enhanced biomarker testing to optimize use.

3. Technological and Policy Influences

Trend	Impact on COTELLIC
Genomic Testing Expansion	Increased eligible patients
Healthcare Cost Containment Policies	Pressure to reduce prices
Personalized Medicine Initiatives	Higher efficacy and adoption

4. Revenue Forecast (2023–2030)

Year	Projected Global Sales (USD Millions)	CAGR
2023	$430	16%
2025	$620	17%
2030	$1,200+	19%

Assumptions: Continued combination therapy adoption, pipeline success, and market expansion.

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What Are the Key Risks and Mitigation Strategies?

Risk	Description	Mitigation Strategies
Resistance Development	Tumor adaptation limits efficacy	Combination therapies, biomarker research
Market Competition	Entry of new drugs	Differentiation through indications, real-world data
Regulatory Delays	New approvals slow pace	Early engagement with regulators
Pricing Pressures	Cost containment policies increase	Value-based pricing, demonstrating cost-effectiveness

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Key Takeaways

• Market Positioning: COTELLIC maintains a mid-tier but growing position in targeted melanoma therapy, strengthened by combination use with BRAF inhibitors.
• Revenue Growth: Steady increase driven by expanded indications, pipeline progress, and international market expansion.
• Competitive Landscape: Faces stiff competition from first-mover trametinib, with advantages in combination regimens and pipeline development.
• Future Opportunities: Diversification into other BRAF-mutant cancers and immunotherapy combinations could significantly boost revenues.
• Risks and Challenges: Resistance, competitive pressures, and regulatory hurdles must be proactively managed.

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FAQs

Q1: How does COTELLIC compare to other MEK inhibitors?
A: COTELLIC generally offers similar efficacy to competitors like trametinib but benefits from strategic combination therapy with BRAF inhibitors, which enhances its clinical utility, especially in melanoma.

Q2: What are the primary indications for COTELLIC?
A: Primarily, it is indicated for BRAF V600 mutation-positive unresectable or metastatic melanoma, in combination with vemurafenib or encorafenib.

Q3: What is the outlook for COTELLIC in non-melanoma cancers?
A: Clinical trials are underway in colorectal, thyroid, and other BRAF-mutant cancers, potentially broadening its therapeutic scope in the next 3–5 years.

Q4: How does pricing affect COTELLIC’s market share?
A: High pricing necessitates value demonstration; cost-effectiveness analyses are critical for payer acceptance and market penetration.

Q5: What upcoming developments could influence COTELLIC’s market trajectory?
A: Successful pipeline progress, label expansions, and strategic partnerships will be key drivers. Conversely, competitive advances in alternative therapies could pose challenges.

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References

1. Roche. (2021). Annual Report 2021.
2. Globocan. (2018). Global Cancer Incidence and Mortality Data.
3. FDA. (2015). COTELLIC (Cobimetinib) Approval Letter.
4. MarketWatch. (2022). Oncology Therapeutics Market Analysis.
5. Company filings and industry reports on BRAF and MEK inhibitors.