Cobimetinib fumarate - Generic Drug Details

What are the generic sources for cobimetinib fumarate and what is the scope of patent protection?

Cobimetinib fumarate is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobimetinib fumarate has two hundred and seven patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for cobimetinib fumarate

International Patents:	207
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	10
DailyMed Link:	cobimetinib fumarate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,590,102*PED

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.

Pharmacology for cobimetinib fumarate

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cobimetinib fumarate

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for cobimetinib fumarate

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	11,597,699
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes

International Patents for cobimetinib fumarate

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 cobimetinib fumarate

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 COBIMETINIB FUMARATE

Last updated: March 4, 2026

What is the current market position for COBIMETINIB FUMARATE?

COBIMETINIB FUMARATE is a BRAF and MEK inhibitor approved initially for melanoma. Its development and commercialization primarily involve Roche, which licensed it from Array BioPharma. As a targeted therapy, it is positioned in the precision oncology segment, focusing on BRAF-mutant cancers.

The drug's market entry was marked by FDA approval in 2017 for unresectable or metastatic melanoma with BRAF V600E/K mutations. It has expanded into other indications, including non-small cell lung cancer (NSCLC) and certain other BRAF-mutant tumors. Revenue from COBIMETINIB FUMARATE has been growing steadily, with complex dynamics influenced by competition, regulatory approvals, and pipeline developments.

Current sales: Roche reported approximately CHF 760 million (roughly $810 million) in sales for VEMURAFENIB and COBAFENIB across all indications in 2022, which includes COBIMETINIB FUMARATE as a combined product in some markets. Exact figures for COBIMETINIB alone are not publicly disclosed but are part of the broader BRAF/MEK inhibitor portfolio.

What are the key factors influencing the drug's market dynamics?

1. Therapeutic competition

Cobimetinib competes primarily with other BRAF inhibitors (Vemurafenib, Dabrafenib) and MEK inhibitors (Trametinib, Encorafenib). This landscape is crowded, with multiple drugs approved for BRAF-mutant melanoma and other cancers.

2. Regulatory approvals and indications

Expansion into NSCLC and other tumors broadens potential revenue streams. Pending approvals or recent clearances in additional markets can significantly influence market share.

3. Cost and reimbursement landscape

Pricing strategies vary across regions. High costs limit access in certain markets, impacting volume sales. Reimbursement policies, especially in the US and Europe, play critical roles.

4. Pipeline and combination therapies

Development of combination treatments with immunotherapies and next-generation targeted agents threaten or complement COBIMETINIB FUMARATE's market position. Failures or delays in pipeline projects can alter future revenues.

5. Patent life and biosimilar entry

Patent expiration for existing formulations could lead to biosimilar or generic entries, pressuring prices and market share.

What is the financial trajectory projected for COBIMETINIB FUMARATE?

Historical revenue

From 2017 through 2022, combined sales of reported BRAF/MEK inhibitors, including COBIMETINIB, grew at a compound annual growth rate (CAGR) of approximately 10%. Specific data for COBIMETINIB is unavailable; thus, estimates are based on the overall portfolio.

Future revenue estimates

Year	Estimated Revenue (USD millions)	Assumptions
2023	$850 - $950	Slight growth driven by continued approvals, expanded indications, and market penetration.
2024	$1.0 - $1.2 billion	Launch in additional indications, increased adoption in combination regimens.
2025	$1.3 - $1.5 billion	Potential patent expiry threats, increased competition.

Key revenue drivers

• Expansion into new indications such as NSCLC.
• Adoption rates in combination therapies.
• Competitive pricing and reimbursement policies.
• Regulatory approvals in emerging markets.

Risks to financial outlook

• Delays in new indications or approvals.
• Entry of biosimilars and generics post patent expiry.
• Market share erosion due to competitors' advancements.
• Regulatory changes affecting pricing policies.

What are the strategic considerations?

Manufacturers plan to bolster pipeline offerings, develop combination regimens, and explore biomarkers for improved patient targeting. Investment in companion diagnostics can drive market penetration. Competition from emerging therapies, including immunotherapies and next-generation targeted agents, requires ongoing innovation.

Summary of key indicators

Indicator	Value/Trend	Comments
Market share (melanoma)	Approximately 20-30%	In melanoma, COBIMETINIB holds a significant share but faces competition.
Patent expiration	Estimated 2025-2027	Patent protections for core formulations are near expiry, risking generics entry.
R&D pipeline	Multiple ongoing studies	Includes combinations with PD-1 inhibitors and novel agents.

Key Takeaways

• COBIMETINIB FUMARATE is a targeted oncology drug with a market share primarily in melanoma.
• Growth is driven by indications expansion, combination therapies, and geographic penetration.
• Competition from other BRAF/MEK inhibitors limits pricing power; biosimilar threats loom after patent expiry.
• Future revenues depend on regulatory success, pipeline progress, and market dynamics.
• Risks include patent expiry, biosimilar entry, and shifts toward immunotherapies.

FAQs

1. What barriers exist for COBIMETINIB FUMARATE's market growth?
Competition from similar targeted therapies and impending patent expiry constrain revenue growth.

2. Which indications are driving future sales?
Non-melanoma BRAF-mutant cancers such as NSCLC and colorectal cancers are primary expansion areas.

3. How does the pipeline impact financial prospects?
Successful development of combination therapies and new indications can significantly boost revenues; delays or failures pose risks.

4. What regional factors influence sales?
Pricing policies, reimbursement frameworks, and approval processes in the US, Europe, and Asia impact market penetration.

5. How vulnerable is COBIMETINIB FUMARATE to biosimilar competition?
Post patent expiry, biosimilars could access markets, reducing prices and market share, unless differentiation strategies are implemented.

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References

1. Roche (2022). Annual Report 2022.
2. U.S. Food & Drug Administration (2017). Approval documents for Cobimetinib.
3. Evaluate Pharma (2022). Oncology Market Report.
4. European Medicines Agency (2019). Summary of Product Characteristics for Cobimetinib.
5. IQVIA (2022). Global Oncology Insights.