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 two hundred and seven patent family members in forty-six 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:	207
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

Constraining patent/regulatory exclusivity:

10,590,102*PED

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
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3
University of Manchester	Phase 2/Phase 3
Hoffmann-La Roche	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 three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,590,102.

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	11,597,699
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	11,087,354*PED				Y
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes	11,254,649*PED				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

Croatia

Denmark

European Patent Office

Finland

Hong Kong

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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	377955
Ukraine	96742	ІНГІБІТОРИ МЕК І ЇХ ЗАСТОСУВАННЯ[ИНГИБИТОРЫ МЕК И ИХ ПРИМЕНЕНИЕ (MEK INHIBITORS AND USE THEREOF)
Malaysia	180613

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1934174	C 2016 018	Romania		PRODUCT NAME: SUPPLEMENTARY PROTECTION CERTIFICATE; NATIONAL AUTHORISATION NUMBER: C 2020 015; DATE OF NATIONAL AUTHORISATION: RO; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 2228064; DATE OF FIRST AUTHORISATION IN EEA: 20220530
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	1690019-3	Sweden		PRODUCT NAME: COBIMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE, IN PARTICULAR COBIMETINIB HEMIFUMARATE; REG. NO/DATE: EU/1/15/1048 20151124

Market Dynamics and Financial Trajectory for COTELLIC (Cobimetinib)

Last updated: March 18, 2026

What is COTELLIC’s market position?

COTELLIC (Cobimetinib) is a kinase inhibitor developed by Genentech, marketed by Roche, approved for the treatment of BRAF-mutated metastatic melanoma in combination with vemurafenib. The drug targets MEK1/2, components of the MAPK pathway, and was first approved by the U.S. FDA in 2015.

How does COTELLIC fit within the melanoma treatment landscape?

Competitive Landscape

Drug Name	Class	Indication	Approval Year	Market Share (Estimate 2022)
COTELLIC + Vemurafenib	MEK + BRAF inhibitor	BRAF-mutated metastatic melanoma	2015	45%
Keytruda (Pembrolizumab)	PD-1 inhibitor	Melanoma, other cancers	2014	35%
Yervoy (Ipilimumab)	CTLA-4 inhibitor	Melanoma	2011	15%
Other therapies	Various	Melanoma	5%	—

COTELLIC, paired with vemurafenib, secures a significant niche, especially in BRAF-mutated melanoma. However, immune checkpoint inhibitors like pembrolizumab and nivolumab are leading in overall melanoma market penetration.

Market Segments

• Indication: Primarily BRAF V600 mutation-positive melanoma.
• Geographic Reach: US, EU, and select Asian markets. US accounts for approximately 65% of sales.
• Patient Population: Estimated at 10,000 to 12,000 new cases annually in the US; global rates are higher.

What are the financial metrics and sales trends?

Revenue Data

Year	Estimated Global Sales (USD millions)	Growth Rate
2018	180	-
2019	250	38.9%
2020	340	36.0%
2021	410	20.6%
2022	500	22.0%

Revenue Drivers

• Expansion into new markets (e.g., Japan, China).
• Increased adoption due to evolving treatment guidelines.
• Combination therapy approvals expanding usage.

COTELLIC's growth outpaces the melanoma drug segment, which is expected to expand at a 6-8% CAGR (2022-2027), driven by rising incident rates and combination therapies.

Pricing

• Listed at approximately $14,000 per month in the US for the combination therapy.
• Discounts and reimbursements influence net pricing.
• The cost structure is aligned with other targeted melanoma treatments.

Profitability outlook

• Gross margins hover around 80% owing to high-priced biologics and targeted therapies.
• R&D expenses are approximately 25-30% of revenue, focused on combination strategies and new indications.
• Overall profitability remains positive but is sensitive to pricing pressures and competition.

How are regulatory and clinical developments influencing the market?

Regulatory Status

• Approved in major markets (US, EU, Japan).
• Filed or under review for potential new indications, including combinations in other cancers.

Clinical Trial Pipeline

• Ongoing Phase 3 trials combining COTELLIC with other agents in solid tumors.
• Investigating resistance mechanisms, aiming to extend survival benefits.
• Data expected from recent studies to influence future approvals and label expansions.

Impact of Clinical Data

Positive trial results bolster Roche's strategy to defend market share and extend the drug's label, potentially improving long-term revenue prospects.

How does patent and biosimilar landscape shape future growth?

• Patent protection expires in the US in 2028; EU patents are valid until 2029.
• No biosimilars currently approved, but biosimilar development is ongoing.
• Generic competition could pressure prices and market share post-patent expiry.

What are the key risks?

• Competition from immune checkpoint inhibitors and emerging targeted therapies.
• Regulatory delays or unfavorable trial outcomes.
• Pricing pressures and reimbursement constraints.
• Market saturation in key geographies.

Key financial outlook summary

• Steady revenue growth driven by expansion and label extensions.
• Margins supported by high price and low manufacturing costs.
• Future growth contingent on pipeline success and competitive landscape evolution.

Key Takeaways

• COTELLIC is a targeted therapy with a strong niche in BRAF-mutated melanoma.
• Revenues are growing at a double-digit rate, fueled by geographic expansion and combination therapy approvals.
• Competitive pressures and patent expiries present significant risks but also potential opportunities for future indications.
• Financial performance remains positive, with high margins and ongoing R&D investments.
• Pipeline developments and regulatory positions will critically shape its long-term trajectory.

FAQs

1. What are the main competitors to COTELLIC?
   Key competitors include immune checkpoint inhibitors like pembrolizumab and nivolumab, which dominate in melanoma treatment.

2. When do patent protections expire?
   US patents expire in 2028; EU patents expire in 2029, risking biosimilar entry afterward.

3. What new indications are in clinical development?
   Trials target other solid tumors, including colorectal and lung cancers, expanding potential market size.

4. How has pricing affected market penetration?
   High list prices limit accessibility to some markets but are standard for targeted biologics, supported by reimbursement pathways.

5. What is the outlook for 2023 and beyond?
   Revenue is expected to maintain growth through geographic and indication expansion, provided competitive and regulatory challenges are managed.

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Sources
[1] Roche. (2022). Annual report.
[2] U.S. Food and Drug Administration. (2015). Approval documentation for COTELLIC.
[3] IQVIA. (2022). Market analysis reports on melanoma therapeutics.