Dacomitinib - Generic Drug Details

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

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

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

Two suppliers are listed for this compound.

Summary for dacomitinib

International Patents:	94
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	36
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dacomitinib
What excipients (inactive ingredients) are in dacomitinib?	dacomitinib excipients list
DailyMed Link:	dacomitinib at DailyMed

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.

Recent Clinical Trials for dacomitinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daiichi Sankyo, Inc.	Phase 2
MedSIR	Phase 2
Swedish Lung Cancer Study Group	PHASE3

See all dacomitinib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for dacomitinib

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	211288-002	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	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	211288-002	Sep 27, 2018
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	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
Norway	2019035
Lithuania	PA2019016
Guatemala	200500103	4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Malaysia	143566	4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
European Patent Office	1848414	METHODE DE TRAITEMENT DU CANCER RESISTANT AU GEFITINIB (METHOD FOR TREATING GEFITINIB RESISTANT CANCER)
World Intellectual Property Organization (WIPO)	2006084058

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	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
1746999	PA2019016	Lithuania		PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999	1990044-8	Sweden		PRODUCT NAME: DACOMITINIB OR APHARMACEUTICAL ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/19/1354 20190404
1848414	C 2016 026	Romania		PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202
1746999	122019000080	Germany		PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402

Market Dynamics and Financial Trajectory for DACOMITINIB

Last updated: July 27, 2025

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Introduction

DACOMITINIB, an investigational tyrosine kinase inhibitor (TKI), has garnered significant attention within the oncology landscape, primarily targeting hematologic malignancies such as myelofibrosis and other myeloproliferative disorders. Its market potential, driven by evolving therapeutic needs and competitive drug development, presents a compelling narrative for stakeholders. This analysis delineates the key market dynamics and forecasts the financial trajectory of DACOMITINIB, considering regulatory pathways, competitive positioning, pharmaceutical investment trends, and unmet clinical needs.

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Market Landscape and Therapeutic Context

Unmet Clinical Needs

Myeloproliferative neoplasms (MPNs), notably myelofibrosis, pose treatment challenges with limited curative options. Current therapies, including ruxolitinib and fedratinib, focus on symptom management and spleen size reduction but often fail to modify disease progression significantly. The advent of DACOMITINIB, with potential for enhanced efficacy and a differentiated safety profile, strives to fill this therapeutic gap. The increasing prevalence of MPNs, exacerbated by aging populations, signals an expanding patient base.

Regulatory Environment and Development Stage

DACOMITINIB is at the advanced clinical trial phase, with pivotal Phase III studies underway. Regulatory agencies, notably the FDA and EMA, are prioritizing accelerated pathways for therapies exhibiting substantial benefit over existing standards. Positive trial outcomes could facilitate expedited approval, accelerating market entry—an essential factor influencing the anticipated financial trajectory.

Competitive Dynamics

The TKI segment for MPNs is saturated with first-generation drugs such as ruxolitinib (Incyte), fedratinib (AbbVie), and emerging agents like momelotinib. DACOMITINIB’s introduction could disrupt or complement existing treatment algorithms, especially if it demonstrates superior efficacy, safety, or convenience. Differentiation through biomarkers or enhanced tolerability could confer competitive advantages, influencing market share acquisition.

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Market Drivers Impacting Financial Outcomes

Efficacy and Safety Profile

Clinical trial data indicating improved symptom control, spleen volume reduction, and reduced adverse events will significantly bolster DACOMITINIB’s market appeal. Conversely, safety concerns could hinder adoption, affecting revenue projections.

Pricing and Reimbursement

Pricing strategies will be pivotal; positioning DACOMITINIB as a premium, differentiated therapy may command higher prices, contingent on demonstrated clinical benefits. Reimbursement negotiations, especially within multi-payer systems, will shape access and uptake rates, directly impacting revenue streams.

Market Penetration Strategies

Physician adoption hinges on robust clinical evidence, strategic key opinion leader (KOL) engagement, and comprehensive marketing campaigns. The duration to achieve substantial market share depends on clinical trial success, regulatory approval timers, and competitive responses.

Intellectual Property and Patent Protection

Patent life extends the window for exclusive sales, typically 10–15 years upon approval, during which revenue streams remain protected. Patent challenges or biosimilar entry, once viability is established, could compress profit margins.

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Financial Trajectory Forecast

Revenue Projections

Assuming successful clinical outcomes and expedited regulatory approval within 2–3 years, initial launch revenues could range from $200 million to $500 million annually by Year 3, depending on market penetration and pricing. As uptake accelerates, revenues may reach $1 billion+, especially if the drug demonstrates a compelling advantage over competitors.

Cost Structure and Investment

Development costs, inclusive of clinical trials (anticipated to total $300–$500 million), regulatory filing expenses, and commercialization investments, will weigh on margins initially. Post-approval, manufacturing, sales, and marketing expenses will constitute ongoing operational costs.

Profitability Timeline

Break-even may occur by Year 4–5, contingent on sales volume, reimbursement success, and manufacturing efficiencies. Peak profitability could materialize in Years 6–8, aligning with market saturation and optimization of commercial strategies.

Long-Term Outlook

If DACOMITINIB secures a strong foothold, the drug could generate cumulative revenues exceeding $5 billion over a decade. Portfolio expansion, including combination therapies or line extensions, could further inflate the financial trajectory.

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Market Risks and Opportunities

Risks

• Regulatory setbacks impeding approval timelines.
• Clinical trial failures resulting in diminished confidence.
• Competitive pressure from established or emerging therapies.
• Pricing and reimbursement constraints reducing market access.
• Patent challenges affecting exclusivity.

Opportunities

• Rapid approval pathways due to unmet need.
• Combination therapy positioning enhancing efficacy.
• Expansion into other indications like solid tumors or related hematologic disorders.
• Partnerships with biotech and payers to facilitate adoption.
• Real-world evidence strengthening market confidence.

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Key Takeaways

• DACOMITINIB’s commercial success hinges on demonstrating significant clinical benefits over existing therapies, alongside strategic regulatory management.
• Early engagement with health authorities can expedite approval, crucial for capturing market share.
• Competitive positioning, particularly through differentiation and pricing strategies, will influence revenue trajectory.
• Infrastructure investments in manufacturing and marketing are essential to maximize market penetration.
• The drug’s long-term revenue potential depends on sustaining patent protection, exploring indication expansion, and adapting to evolving market dynamics.

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Frequently Asked Questions

1. When is DACOMITINIB expected to receive regulatory approval?
Pending positive trial results and submission timelines, regulatory agencies may grant approval within 12–24 months post-application, assuming no significant issues arise.

2. How does DACOMITINIB compare to existing TKIs in efficacy?
Preliminary phase 2 data suggest improved symptom control and tolerability, but definitive comparisons await Phase III trial outcomes.

3. What factors could impede DACOMITINIB’s market entry?
Regulatory hurdles, unfavorable trial results, patent disputes, or an inability to secure reimbursement could delay or limit market access.

4. What is the potential for DACOMITINIB in indications beyond myelofibrosis?
Exploration in related hematologic malignancies and solid tumors may expand its market, contingent on favorable early-phase trial results.

5. How can pharmaceutical companies position DACOMITINIB for maximum market impact?
Investing in clinical evidence, early engagement with payers, differentiated pricing, and education campaigns targeting clinicians will be critical.

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Sources

1. [1] GlobalData. “Pipeline Analysis of Tyrosine Kinase Inhibitors for Hematologic Malignancies.” 2022.
2. [2] FDA. “Fast Track Designation for Emerging Oncology Drugs.” 2023.
3. [3] Oncology Market Reports. “Myelofibrosis Therapeutics: Market Trends and Forecasts.” 2022.
4. [4] ClinicalTrials.gov. “DACOMITINIB Clinical Trials Database.” 2023.
5. [5] IQVIA. “Pharmaceutical Sales and Market Access Trends.” 2022.

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