dacomitinib - Profile

What are the generic drug sources for dacomitinib and what is the scope of freedom to operate?

Dacomitinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dacomitinib has ninety-three patent family members in forty-eight countries.

Summary for dacomitinib

International Patents:	93
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dacomitinib

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

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 dacomitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No

Expired US Patents for dacomitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018

EU/EMA Drug Approvals for dacomitinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Vizimpro	dacomitinib	EMEA/H/C/004779Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.	Authorised	no	no	no	2019-04-02

International Patents for dacomitinib

Country	Patent Number	Title	Estimated Expiration
Japan	4966923
Lithuania	C1746999
Mexico	PA06012756	4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS. (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES.)
Poland	1848414

Supplementary Protection Certificates for dacomitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	CR 2019 00043	Denmark		PRODUCT NAME: DACOMITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1354 20190404
1848414	122016000056	Germany		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1746999	705	Finland
1746999	LUC00127	Luxembourg		PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404

Dacomitinib: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Dacomitinib (brand name: Vizimpro®) is an orally administered, irreversible pan-HER (human epidermal growth factor receptor) inhibitor developed by Pfizer, primarily indicated for non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) activating mutations. The drug has demonstrated efficacy in patients harboring specific genetic alterations, though its market penetration remains sensitive to competitive dynamics, regulatory approvals, and emerging targeted therapies.

This analysis explores the current and forecasted market landscape for dacomitinib, including clinical positioning, competitive environment, sales potential, regulatory considerations, and strategic implications for investors. Through examining global market variables, clinical data, and economic factors, this report provides a comprehensive outlook for stakeholders considering investment or strategic partnerships related to dacomitinib.

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Current Market Overview

Aspect	Details
Indication	Advanced/metastatic NSCLC with EGFR-activating mutations (first-line setting)
Approval Status	Approved in the US (FDA, 2018), EU, Japan; EMA granted conditional approval in 2019
Key Competitors	Osimertinib (Tagrisso®), Erlotinib (Tarceva®), Afatinib (Gilotrif®)
Market Size (Global NSCLC)	Estimated at $22 billion in 2022, projected to grow CAGR 8% through 2030[1]
Sales (2022)	Approximately $350 million globally (Pfizer reports)[2]

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Investment Scenario for Dacomitinib

Market Penetration and Revenue Projections

Year	Projected Global Sales	Assumptions	Notes
2023	$400 million	Moderate uptake in US/EU, competition persists	Launch of new combination therapies may slow growth
2025	$650 million	Expanded label indications and data	Potential approval for first-line use in broader populations
2030	$1.2 billion	Increasing adoption, first-line status in some markets	Increases based on label expansion, pricing power, and pipeline developments

Key Variables:

• Market penetration rate: Historically (~30-50%) in approved indications.
• Pricing strategy: Expected at premium levels due to targeted therapy positioning (~$10,000-15,000/month).
• Patent expiration: Patents expiring circa 2027, risking biosimilar/equivalent erosion after.

Regulatory Pathways and Approvals

• FDA: Approved (2018) for second-line treatment; potential for expansion into first-line indications pending phase III results.
• EMA/EU: Conditional approval, with ongoing post-market studies.
• Japan: Approved, with regional pricing negotiations influencing revenue.

Development Pipeline and Future Opportunities

Development Stage	Indication	Expected Completion	Strategic Implication
Phase III	First-line NSCLC in EGFR-mutant tumors	2024-2026	Significant revenue upside if successful
Combination Trials	Dacomitinib + PD-1 inhibitors, chemotherapy	Ongoing	Potential for synergy and market expansion

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Market Dynamics Affecting Dacomitinib

Competitive Landscape

Competitor	Mechanism	Market Share (2022)	Differentiators
Osimertinib	Third-generation EGFR TKI	~70% of EGFR TKI sales	Superior CNS penetration, resistance profile
Erlotinib	First-generation TKI	Declining	Cost-effective, established brand
Afatinib	Irreversible broad-spectrum EGFR TKI	Declining	Broader mutation coverage

Chart: Market Share of Key EGFR Inhibitors (2022)[3]

Drug	Approximate Market Share	Key Features
Osimertinib	70%	Potent, CNS-active, resistance management
Erlotinib	15%	Older, cost-effective
Afatinib	10%	Broader mutation activity
Dacomitinib	5%	Competitive, with specific patient subset

Regulatory and Reimbursement Trends

• Enhanced reimbursement policies favor targeted therapies.
• Breakthrough Therapy Designation or FDA Priority Review could accelerate approvals.
• Pricing pressures, especially in Europe and emerging markets, influence profit margins.

Market Entry Barriers and Opportunities

Barriers	Opportunities
High clinical trial costs and timeline	Successful trial outcomes unlock premium pricing
Patent expiration risks	Strategic partnerships for pipeline expansion
Competition from proven EGFR inhibitors	Focus on unique therapeutic niches (e.g., unmet mutations or resistance profiles)

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Financial Trajectory and Investment Risks

Factor	Impact
Patent expiry (approx. 2027)	Price erosion, biosimilar competition
Clinical trial outcomes	Positive results can dramatically increase value, negative results risk retention
Market acceptance and reimbursement policies	Significantly influence sales and profitability
Competitive innovation	New entrants or combination therapies may displace monotherapy efficacy

Financial Projections Summary:

Year	Revenue Range	CAGR	Notes
2023	$400M - $450M	N/A	Initial stabilization, moderate uptake
2025	$650M - $750M	~15%	Expansion in first-line indications, pipeline data favorable
2030	$1.2B - $1.5B	~20%	Market dominance if label expansion and approval achieved

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Comparative Market Analysis

Drug	Approved Indication	Market Share (2022)	Price Point	Strengths	Weaknesses
Osimertinib	First-line and resistance settings	70%	~$13,000/month	CNS activity, resistance profile	Higher cost, resistance eventuality
Dacomitinib	Second-line NSCLC, potential expansion	5%	~$12,000/month	Irreversible inhibitor, targeted use	Competed by more advanced agents, toxicity concerns
Erlotinib	Broad NSCLC use	15%	~$6,000/month	Cost-effective	Less effective against resistance, CNS penetration
Afatinib	First-line NSCLC	10%	~$10,000/month	Broad mutation activity	Toxicity profile, competition from osimertinib

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Policy and Market Access Considerations

• Price negotiations: Governments and payers in Europe and Asia institute price controls leading to potential revenue constraints.
• Reimbursement: Favorable in markets valuing advanced targeted therapies; hindered by budget constraints.
• Regulatory pathways: Fast-track designations and expedited reviews are critical for rapid market entry or expansion.

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Key Differences and Strategic Fit

Aspect	Dacomitinib	Market Positioning
Clinical niche	Second-line in EGFR-mutant NSCLC	Competes with osimertinib in second-line
Pipeline potential	First-line indication expansion and combos	High, contingent on trial outcomes
Patent lifecycle	Expiring in 2027	Strategic timing for lifecycle management
Pricing strategy	Premium pricing comparable to competitors	Sensitive to reimbursement trends

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Key Takeaways

• Market potential for dacomitinib hinges on demonstrating superior efficacy in newly approved indications, especially first-line NSCLC.
• Competitive pressures from osimertinib and other third-generation TKIs necessitate strategic differentiation, possibly via combination therapies.
• Regulatory momentum could unlock significant revenue if dacomitinib receives expanded approval, but patent expiration risks eroding profit margins post-2027.
• Pipeline developments are critical; multiple ongoing trials could significantly shift market share if results favor the drug.
• Pricing and reimbursement strategies should align with regional acceptance, especially as biosimilar competition looms.

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FAQs

Q1: What is the current therapeutic positioning of dacomitinib in NSCLC treatment?
Dacomitinib is primarily used as a second-line treatment for EGFR-mutant NSCLC, with potential future indications in the first-line setting pending additional trial data and regulatory approval.

Q2: How does dacomitinib compare to osimertinib?
While both target EGFR mutations, osimertinib is favored due to its superior CNS penetration and resistance profile, capturing the majority of the market share; dacomitinib faces challenges competing directly without differentiation.

Q3: What are the main patent expiry risks for dacomitinib?
Patents are expected to expire circa 2027, leading to increased biosimilar competition and pricing pressures in key markets.

Q4: What are the prospects for global commercialization?
Strong potential exists in North America and Europe, especially if approvals extend to first-line indications; emerging markets offer growth opportunities but with pricing and reimbursement limitations.

Q5: What are the strategic opportunities for investors?
Investors should monitor clinical trial outcomes, regulatory decisions, and pipeline developments; strategic alliances could optimize market entry timelines and maximize lifecycle value.

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References

[1] GlobalData, "NSCLC Market Analysis," 2022.
[2] Pfizer Annual Report, 2022.
[3] MarketWatch, "EGFR Inhibitors Market Share," 2022.