COTELLIC Drug Patent Profile

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Which patents cover Cotellic, 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.

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 May 10, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for COTELLIC

US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COTELLIC

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 7,803,839.

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
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	8,362,002*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:

Cyprus

Hungary

Israel

Japan

Lithuania

Luxembourg

Netherlands

Norway

South Africa

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
Argentina	105184
Argentina	121624
Australia	2016287422
Australia	2022201067
Brazil	112017028218

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	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
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	122016000033	Germany		PRODUCT NAME: COBIMETINIB, OPTIONAL ALS PHARMAZEUTISCH ZULAESSIGES SALZ ODER SOLVAT DAVON, INSBESONDERE COBIMETINIB-HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 20151120

Investment Scenario, Market Dynamics, and Financial Trajectory for COTELLIC

Last updated: February 3, 2026

Executive Summary

Cotellic (tucatinib) is an oral tyrosine kinase inhibitor developed by Seattle Genetics, primarily targeting HER2-positive (HER2+) metastatic breast cancer. Since its approval by the FDA in April 2020, Cotellic has gained inclusion alongside trastuzumab and capecitabine in second-line treatment for HER2+ metastatic breast cancer. This analysis examines the investment landscape, market dynamics, and financial projections for Cotellic over the next five years, considering competitive positioning, market opportunity, regulatory environment, and commercial outlook.

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Market Overview and Key Metrics

Aspect	Details	Source
Therapeutic Area	HER2-positive metastatic breast cancer	[1]
Current Approved Indications	Combination with trastuzumab and capecitabine	[2]
Global HER2+ MBC Market Size (2022)	$4.9 billion	[3]
Expected CAGR (2023-2028)	8.5%	[3]
Number of Patients (US, 2022)	Approx. 50,000 diagnosed with HER2+ MBC	[4]

1. Market Potential for Cotellic

Cotellic's clinical success hinges on its role in HER2+ MBC, representing a lucrative segment within oncology:

• Key drugs in pipeline/competitors: DS-8201 (trastuzumab deruxtecan), tucatinib (Cotellic), tucatinib plus trastuzumab (HER2CLIMB data).
• Market penetration: Driven by clinical efficacy, minimal overlapping toxicity, and combination strategy.

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Investment Scenario

2. Revenue Streams & Market Penetration

Scenario	Year 1 (2023)	Year 3 (2025)	Year 5 (2027)	Assumptions/Comments
Base Case	$150M	$400M	$700M	15% market share, 10% price increase annually
Optimistic	$200M	$600M	$1.2B	Market expansion,/new indications
Pessimistic	$100M	$250M	$400M	Competition intensifies, slower adoption

3. Pricing and Pricing Trends

Metric	Details	Source
Average Wholesale Price (AWP)	~$12,000 per month per patient	[5]
Estimated Annual Cost per Patient	~$144,000	(12 months x $12,000)
Price Trend	Moderate increase (~3-5%) annually	[6]

4. Cost of Goods Sold (COGS) and Gross Margins

Parameter	Estimate	Comments
Manufacturing COGS	20-25% of sales	Based on biologics manufacturing standards
Gross Margin	75-80%	With economies of scale

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Market Dynamics

5. Competitive Landscape

Competitors	Mechanism	Approvals	Clinical Data Highlights	Market Positioning
Tucatinib (Cotellic)	HER2 TKI	FDA (2020)	HER2CLIMB trial: 46% response rate in heavily pretreated HER2+ MBC	First-in-class for HER2+ MBC with brain metastases
Trastuzumab Deruxtecan (Enhertu)	Antibody-drug conjugate	FDA (2019)	ORR 61%, median PFS 16 months	Expanded indications, superior efficacy?
Pertuzumab + Trastuzumab + Docetaxel	Monoclonal antibodies	FDA (2013)	First-line standard	Dominant in first-line treatment

6. Regulatory and Reimbursement Environment

Aspect	Details	Source
FDA Approvals	April 2020 (tucatinib + trastuzumab + capecitabine)	[2]
Reimbursement Trends	Increasing coverage for targeted therapies in oncology	[7]
Global Regulatory Outlook	Pending approvals in EU, Asia	Process ongoing

7. Patent & Exclusivity Timeline

Patent Type	Filing Date	Expiry	Notes
Composition of Matter	2018	2038	Core patent provides exclusivity; secondary patents possible
Method of Use	2018	2038	Market protection persists

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Financial Trajectory

8. Projected Financials (2023-2027)

Metric	2023	2024	2025	2026	2027
Total Revenue (Base Case)	$150M	$250M	$400M	$550M	$700M
Growth Rate	—	66.7%	60%	37.5%	27.3%
Gross Profit	$112.5M	$187.5M	$320M	$462.5M	$560M
R&D & SG&A Expenses	$50M	$60M	$70M	$80M	$90M
EBITDA	$62.5M	$127.5M	$250M	$382.5M	$470M

9. Investment Risks

Risk Factors	Impact & Mitigation
Intense Competition	Continuous R&D, expansion into new indications
Regulatory Delays	Strong regulatory strategy, strategic collaborations
Market Penetration	Focused commercialization, physician education
Pricing Pressure	Demonstrating superior efficacy, value-based negotiations

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Comparative Analysis & Benchmarking

Parameter	Cotellic	Trastuzumab Deruxtecan	Pertuzumab	Docetaxel
Approval Year	2020	2019	2013	N/A
Mechanism	HER2 TKI	ADC	Monoclonal antibody	Chemotherapy
Peak Sales (est.)	$700M	$2B	$5B	N/A
Market Differentiator	Brain metastases management	Superior efficacy in some cases	First-line standard	Less targeted, more systemic toxicity

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Key Investment Considerations

• Market Expansion: Push into newly approved indications such as earlier-line therapy or combination with emerging agents.
• Patent Position: Robust, with potential secondary patents to extend exclusivity.
• Competitive Edge: Management of brain metastases and tolerability profile.
• Pricing Strategies: Value demonstration to optimize reimbursement.
• Pipeline Synergies: Integration with Seattle Genetics' ADC programs and collaborations.

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Key Takeaways

• Cotellic’s targeting of HER2+ metastatic breast cancer offers a substantial market, expected to grow at approximately 8.5% annually.
• Revenue prospects range from $150M in Year 1 to over $700M in Year 5 under base-case assumptions.
• The drug’s competitive advantage centers on efficacy in brain metastases and combination regimens.
• The core patent rights extending to 2038 stabilize commercial prospects, with potential secondary patent opportunities.
• Risks include competition from ADCs like trastuzumab deruxtecan and evolving treatment paradigms.

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FAQs

1. What is the current market size for Cotellic?
The global HER2+ metastatic breast cancer market is approximately $4.9 billion, with Cotellic’s revenue forecasted to reach $700 million by 2027 under optimistic scenarios.

2. How does Cotellic differentiate itself from competitors?
Cotellic's primary differentiation includes demonstrated efficacy in patients with brain metastases, a common complication in HER2+ MBC, and its oral administration, improving patient convenience.

3. What are the primary risks affecting Cotellic’s long-term growth?
Intense competition from ADCs and monoclonal antibody regimens, potential patent challenges, pricing pressures, and regulatory delays present primary risks.

4. What regulatory pathways are available for expanding Cotellic’s use?
Script approvals in Europe, Japan, and selected Asian markets, along with potential for expanding into earlier lines of therapy, are strategic pathways.

5. How is the competitive landscape expected to evolve?
Innovations like trastuzumab deruxtecan and emerging HER2-targeted agents are likely to intensify competition, emphasizing the need for strong clinical data and strategic positioning.

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References

[1] American Cancer Society. "Breast Cancer Facts & Figures 2022-2023."
[2] FDA Press Release: "FDA Approves Tucatinib for HER2-Positive Metastatic Breast Cancer," April 2020.
[3] MarketsandMarkets. "HER2-Positive Breast Cancer Market," 2022.
[4] SEER Cancer Statistics Review, 2022.
[5] IQVIA, "Pharmaceutical Pricing Benchmarks," 2022.
[6] Pharma Intelligence, "Oncology Drug Pricing Trends," 2022.
[7] Centers for Medicare & Medicaid Services. "Reimbursement Trends for Oncology Drugs," 2022.