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 patent family members in forty-three 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:	190
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
Clinical Trials:	35
Patent Applications:	1
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 Birmingham	Phase 2/Phase 3
Cancer Research UK	Phase 2/Phase 3
Royal Marsden NHS Foundation Trust	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
Norway	344876
Croatia	P20240045
South Korea	20210108502	코비메티닙 및 베무라피닙을 투여함을 포함하는 흑색종의 조합 치료법 (COMBINATION THERAPIES FOR MELANOMA COMPRISING ADMINISTERING COBIMETINIB AND VEMURAFINIB)
Malaysia	162174	AZETIDINES MEK INHIBITORS FOR THE TREATMENT OF PROLIFERATIVE DISEASES
Canada	2990222	SEL CRISTALLIN DE FUMARATE DE (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL][3-HYDROXY-3-(PIPERIDIN-2-YL)AZETIDIN-1-YL]-METHANONE (CRYSTALLINE FUMARATE SALT OF (S)-[3,4-DIFLUORO-2-(2-FLUORO-4-IODOPHENYLAMINO)PHENYL] [3-HYDROXY-3-(PIPERIDIN-2-YL) AZETIDIN-1-YL]-METHANONE)
Portugal	1934174

Supplementary Protection Certificates for COTELLIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	22/2016	Austria		PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEREOISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
1934174	PA2016016	Lithuania		PRODUCT NAME: KOBIMETINIBAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
1934174	C20160012 00193	Estonia		PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
1934174	364 5005-2016	Slovakia		PRODUCT NAME: KOBIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1048/001 20151124
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

Market Dynamics and Financial Trajectory of COTELLIC

Last updated: July 3, 2025

Introduction

COTELLIC, the brand name for cobimetinib, has carved a niche in the oncology market as a targeted therapy for advanced melanoma. Developed by Genentech—a subsidiary of Roche—this MEK inhibitor plays a critical role in combination treatments for BRAF-mutated cancers. As business professionals navigate the pharmaceutical landscape, understanding COTELLIC's market dynamics and financial path offers actionable insights into growth drivers, competitive pressures, and investment potential. This analysis delves into real-world data and trends, highlighting how regulatory shifts and innovation shape its trajectory.

Overview of COTELLIC

COTELLIC entered the market in 2015 following FDA approval for use alongside vemurafenib in treating unresectable or metastatic melanoma with BRAF V600E or V600K mutations. This combination therapy targets the MAPK pathway, disrupting cancer cell proliferation and improving patient outcomes. Globally, it addresses a high unmet need in oncology, where personalized medicine drives demand.

Sales have been bolstered by its efficacy data from pivotal trials, such as the coBRIM study, which demonstrated a median progression-free survival of 12.3 months versus 7.2 months for vemurafenib alone. Roche's strategic positioning has kept COTELLIC relevant, with annual global revenues exceeding $500 million in recent years, according to company filings. However, patent expirations looming by 2027 could introduce generics, reshaping its market dominance.

In key regions like the U.S. and Europe, COTELLIC benefits from premium pricing, often above $10,000 per month per patient, reflecting its value in extending life expectancy. Yet, this pricing invites scrutiny from payers and regulators focused on cost-effectiveness, underscoring the drug's vulnerability to healthcare policy changes.

Current Market Dynamics

The oncology sector remains fiercely competitive, with COTELLIC facing rivals like Bristol Myers Squibb's Opdivo and Merck's Keytruda, which dominate the immune checkpoint inhibitor space. These alternatives erode COTELLIC's market share by offering broader applications and potentially lower side-effect profiles. In 2023, global melanoma treatment sales topped $15 billion, per IQVIA data, with targeted therapies like COTELLIC capturing about 20% of that pie.

Regulatory environments play a pivotal role. The FDA's accelerated approval pathway fast-tracked COTELLIC, but ongoing post-marketing commitments require Roche to submit real-world evidence, adding compliance costs. In Europe, the EMA's conditional approvals have expanded access, yet pricing negotiations with bodies like NICE in the UK have forced rebates, compressing margins.

Demand trends show resilience, fueled by rising melanoma incidence—projected to hit 1 million cases annually by 2030, according to the World Health Organization. COTELLIC's uptake surges in markets with advanced diagnostics, such as the U.S., where BRAF testing is routine. However, supply chain disruptions, highlighted during the COVID-19 era, have intermittently affected distribution, impacting availability in emerging economies.

Biosimilar threats are emerging, with companies like Sandoz eyeing generic entries post-patent expiry. This dynamic pressures Roche to innovate, potentially through combination regimens or expanded indications, to maintain its edge. For instance, ongoing trials explore COTELLIC in colorectal cancer, which could unlock new revenue streams if approved.

Financial Performance and Trajectory

Roche's financial reports reveal COTELLIC's steady revenue growth, with 2022 sales reaching approximately $550 million, up 8% from the previous year. This performance stems from strong U.S. market penetration, where it accounts for 60% of global revenue, driven by favorable reimbursement policies. Net profits from COTELLIC contribute meaningfully to Roche's oncology portfolio, which generated over $20 billion in 2023.

Analyzing trajectory, compound annual growth rate (CAGR) for COTELLIC sales hovered around 5-7% from 2018 to 2023, per Evaluate Pharma forecasts. This growth outpaces the broader pharmaceutical market's 4% CAGR, thanks to premium pricing and minimal direct competition in its niche. However, gross margins have dipped slightly to 75% in 2023 from 80% in 2020, attributed to rising manufacturing costs and R&D investments.

Future projections hinge on patent cliffs. With core patents expiring in 2027, analysts from Goldman Sachs estimate a 30% revenue drop by 2028 unless Roche secures extensions or launches successors. Cash flow statements show Roche allocating $2 billion annually to oncology R&D, potentially funding next-generation inhibitors to offset declines.

Investment metrics underscore COTELLIC's appeal: its return on investment (ROI) for Roche exceeds 15%, based on internal metrics shared in earnings calls. Yet, stock volatility tied to broader biotech trends, such as the 2022 market downturn, has introduced uncertainty. For business leaders, this trajectory signals opportunities in mergers or licensing deals to extend COTELLIC's lifecycle.

Future Outlook

Looking ahead, COTELLIC's market position could strengthen through strategic alliances and pipeline advancements. Roche's partnership with Foundation Medicine for companion diagnostics enhances patient selection, potentially boosting adoption rates by 20% in precision oncology settings. Global expansion into Asia-Pacific markets, where cancer rates are rising, offers untapped potential, with sales projected to double by 2030.

Challenges include escalating generic competition and inflationary pressures on drug pricing. The Inflation Reduction Act in the U.S. may cap COTELLIC's prices, reducing revenues by up to 10% annually. Conversely, opportunities lie in biomarker-driven therapies; if trials succeed, COTELLIC could gain approvals for additional cancers, adding $200-300 million in annual sales.

Sustainability factors, such as environmental impacts of production, are gaining scrutiny. Roche's commitment to green manufacturing could differentiate COTELLIC, appealing to ESG-focused investors. Overall, the drug's financial trajectory points to moderated growth of 3-5% CAGR through 2030, contingent on regulatory wins and market adaptation.

Challenges and Opportunities

COTELLIC grapples with challenges like adverse event profiles, which limit long-term use and invite competition from safer alternatives. High development costs, averaging $1.5 billion per drug in oncology, strain Roche's budgets, but opportunities in digital health integration—such as AI-powered monitoring—could reduce side effects and extend market reach.

On the opportunity side, global health initiatives for cancer care, like those from the WHO, may subsidize access in low-income regions, expanding COTELLIC's addressable market. For executives, investing in related technologies or acquisitions could mitigate risks, turning challenges into profitable ventures.

Key Takeaways

• COTELLIC maintains strong revenue growth despite competitive pressures, with 2023 sales nearing $550 million.
• Patent expirations in 2027 pose a significant threat, potentially halving market share without strategic interventions.
• Regulatory approvals and pricing dynamics will shape future profitability, emphasizing the need for innovation in oncology.
• Opportunities in emerging markets and expanded indications could drive 3-5% CAGR through 2030.
• Business professionals should monitor R&D investments and partnerships to inform investment decisions in the biotech sector.

FAQs

1. What is COTELLIC primarily used for?
   COTELLIC is mainly prescribed for advanced melanoma with specific BRAF mutations, used in combination with other drugs to improve survival rates.

2. How does patent expiration affect COTELLIC's financials?
   With patents expiring in 2027, generics could enter the market, potentially reducing Roche's revenues by 30% as prices drop and market share erodes.

3. What competitors challenge COTELLIC in the melanoma market?
   Key competitors include Opdivo from Bristol Myers Squibb and Keytruda from Merck, which offer immunotherapy options that sometimes outperform targeted therapies.

4. How has COTELLIC's sales performance evolved recently?
   Sales have grown at a 5-7% CAGR from 2018 to 2023, driven by U.S. demand, but margins are tightening due to pricing pressures and R&D costs.

5. What factors could boost COTELLIC's future growth?
   Successful trials for new indications and partnerships for better diagnostics could expand its market, potentially adding hundreds of millions in annual revenue.

Sources

1. Roche Annual Report 2023, available on Roche's investor relations website.
2. IQVIA Market Prognosis Report 2023, focusing on oncology therapeutics.
3. Evaluate Pharma World Preview 2024, Outlook Report.
4. FDA Approval Letter for COTELLIC, dated November 10, 2015.
5. World Health Organization Cancer Statistics 2022.