cobimetinib fumarate - Profile

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What are the generic sources for cobimetinib fumarate and what is the scope of freedom to operate?

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.

Summary for cobimetinib fumarate

International Patents:	207
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobimetinib fumarate

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

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.

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

Expired US Patents for cobimetinib fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015

International Patents for cobimetinib fumarate

Country	Patent Number	Title	Estimated Expiration
Argentina	105184
Argentina	121624
Australia	2016287422

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	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	C01934174/01	Switzerland		PRODUCT NAME: COBIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65620 24.08.2015

Investment Scenario and Fundamentals Analysis for Cobimetinib Fumarate

Last updated: February 21, 2026

What is Cobimetinib Fumarate?

Cobimetinib fumarate is an oral MEK (mitogen-activated protein kinase kinase) inhibitor used primarily in combination with other oncology agents. It targets the MAPK pathway, which is often dysregulated in cancers such as melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer. Approved by the FDA in 2015 for BRAF V600 mutation-positive melanoma, it is marketed by Genentech/Roche.

Market Position and Commercial Status

• Approved Indications: Melanoma (combination with vemurafenib), ongoing trials expanding to other cancers.
• Estimated Market Size (2022): USD 1.2 billion globally, with expansion potential due to pipeline developments.
• Pricing: Approximate wholesale price (per 50 mg tablet): USD 12–15, depending on the market.

Key Components of Investment Analysis

Market Penetration and Growth Forecast

• Current Penetration: Limited predominantly to melanoma, with off-label exploratory use in NSCLC and colorectal cancer.
• Expansion Potential: High, if additional approvals are granted based on ongoing trials.
• Projected CAGR (2023–2028): 8%, driven by broader indications and increasing adoption in combination therapies.

Development Pipeline and Clinical Trials

• Ongoing Phase II/III Trials:
  • Combination with anti-PD-1 therapies.
  • Use in colorectal and NSCLC.
• Potential New Indications: Limited data but promising early results suggest expansion into other cancers with MAPK pathway dysregulation.
• Key Trials (as of Q1 2023):
  • NCT04562285 (colorectal cancer).
  • NCT03190889 (NSCLC).

Competitive Landscape

Competitor	Mechanism	Indications	Market Share (est.)	Status
Selumetinib	MEK inhibitor	Melanoma, NSCLC	15%	Approved, marketed
Binimetinib	MEK inhibitor	Melanoma, colorectal	10%	Approved, competition
Trametinib	MEK inhibitor	Melanoma, NSCLC	20%	Approved, dominant

Cobimetinib’s differentiation involves its combination efficacy with vemurafenib and potentially fewer side effects.

Intellectual Property Position

• Patent Protection: Patents extend into the late 2020s, with orphan drug exclusivity in certain territories.
• Patent Challenges: Some patent challenges are underway in certain jurisdictions, but overall strength remains intact.

Regulatory and Policy Environment

• FDA Status: Approved for melanoma; additional indications under trial.
• EMA Status: Approved similarly in Europe.
• Reimbursement Landscape: Favorable in developed markets; reimbursement uncertainty exists in emerging markets.

Financial Fundamentals

Revenue and Cost Structure

• Revenue (2022): Approximately USD 550 million; primarily from melanoma indications.
• Cost of Goods Sold (COGS): Estimated at 20–25% of revenue.
• R&D Spending: USD 350 million annually; focuses on expanding indications.
• Profitability: Margins around 25-30%, subject to patent expirations and competition.

Investment Risks

• Patent Expiry: Not until late 2020s, but biosimilar threats may emerge.
• Pipeline Risks: Early-stage trials may not result in approvals.
• Market Competition: Dominant from other MEK inhibitors, especially trametinib.
• Pricing Pressure: Potential in price-sensitive markets could impact margins.

Valuation Metrics and Investment Outlook

Metric	2022 Data	Outlook	Caveats
Revenue	USD 550 million	CAGR 8%	Growth driven by pipeline approval and expanded indications
EBITDA Margin	28%	Stable	Cost containment and patent protections support margins
R&D Spend	USD 350 million	Slight increase	Necessary for pipeline expansion
Market Cap	USD 8 billion	Potential to grow	Based on pipeline and market expansion

Investment Thesis Summary

Cobimetinib fumarate exhibits moderate growth prospects within oncology, benefiting from approved combination regimens and ongoing trials exploring additional indications. The key investment opportunities depend on pipeline success, market expansion, and competitive positioning. Risks include patent challenges and market competition.

Key Takeaways

• Cobimetinib fumarate's primary revenue driver is its approved use in melanoma, with potential growth from new indications.
• The product’s market size is expanding with ongoing clinical trials, especially in NSCLC and colorectal cancers.
• Competition from other MEK inhibitors remains intense but cobimetinib’s combination efficacy provides differentiation.
• The patent estate is robust into the late 2020s, with some uncertainties regarding biosimilar entry.
• The financial outlook is positive, with growth driven by indications expansion and sustained R&D investment.

FAQs

1. What are the main risks of investing in cobimetinib fumarate? Patent expiration, pipeline failure, competitive pressure, and pricing regulations.
2. How does cobimetinib compare to other MEK inhibitors? It has comparable efficacy but benefits from combination strategies with BRAF inhibitors, with a competitive edge in specific indications.
3. What is the potential for broader indications? Significant, as early trial results for colorectal and NSCLC show promise.
4. When might patent expiration affect sales? Late 2020s; biosimilar entry could pressure pricing earlier.
5. How does pricing impact profitability? High prices support margins but are susceptible to pricing pressure in emerging markets and healthcare reforms.

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References

[1] FDA. (2022). Drug Approvals and Safety Notifications. U.S. Food & Drug Administration.
[2] marketwatch.com. (2023). Global Oncology Market Size and Growth.
[3] ClinicalTrials.gov. (2023). Ongoing trials involving cobimetinib.
[4] IQVIA. (2022). Pharmaceutical market data.
[5] Roche. (2022). Annual report.