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 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.

Two suppliers are listed for this compound.

Summary for dacomitinib

International Patents:	93
US Patents:	3
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

Constraining patent/regulatory exclusivity:

7,772,243

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
Region Skane	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	211288-003	Sep 27, 2018		RX	Yes	Yes	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No	7,772,243		Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes	7,772,243		Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No	7,772,243		Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No	10,596,162

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	8,623,883
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018	10,596,162
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018	10,596,162
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018	8,623,883
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018	10,596,162
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018	10,603,314
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018	10,603,314

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
Slovenia	1746999
Panama	8631901	4-FENILLAMINO-QUINAZOLIN-6-IL-AMIDAS
Cyprus	1111676
Taiwan	200540163	4-Phenylamino-quinazolin-6-yl-amides
Lithuania	PA2019016
Eurasian Patent Organization	200601849	4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ
Hong Kong	1106432

Supplementary Protection Certificates for dacomitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	132019000000119	Italy		PRODUCT NAME: DACOMITINIB E SUOI SALI ED ESTERI(VIZIMPRO ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1354, 20190404
1848414	300824	Netherlands		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
1746999	C20190030 00298	Estonia		PRODUCT NAME: DAKOMITINIIB;REG NO/DATE: EU/1/19/1354 04.04.2019
1848414	122016000056	Germany		PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1746999	C01746999/01	Switzerland		FORMER OWNER: WARNER-LAMBERT COMPANY LLC, US
1746999	2019C/540	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1848414	132016000078445	Italy		PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204

Market Dynamics and Financial Trajectory for Dacomitinib

Last updated: February 13, 2026

Dacomitinib (brand name: Vizura) is an orally administered, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). Approved by the FDA in 2018 for treatment of first-line non-small cell lung carcinoma (NSCLC) with EGFR exon 19 or 21 mutations, its market prospects are shaped by competitive, patent, regulatory, and clinical factors.

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Market Overview

Competitive Landscape

Dacomitinib faces competition primarily from osimertinib (Tagrisso), which has broader approval and a stronger position based on clinical outcomes. Osimertinib's approval in 2018 for first-line NSCLC and its superior efficacy metrics diminish dacomitinib's market share.

• Key competitors:
  • Osimertinib (AstraZeneca)
  • Erlotinib (Tarceva)
  • Gefitinib (Iressa)

Market Size

The global NSCLC therapeutics market was valued at approximately USD 8.2 billion in 2020 and is expected to grow at a CAGR of 8.3%, reaching USD 15 billion by 2027[1]. Dacomitinib's target segment is a subset within this market, primarily within first-line EGFR-mutant NSCLC.

• Prevalence of EGFR mutations: 10-15% in Western populations, up to 40% in Asian populations.
• Market penetration: Limited, due to competition and clinical positioning.

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Regulatory and Patent Landscape

Dacomitinib's patent protection was initially secured through baseline patents expiring around 2025-2027 in the U.S. and Europe, with extensions possibly pending. Post-patent expiration, generic versions could enter the market, significantly reducing revenue.

• Regulatory approvals: FDA (2018), EMA (2019)
• Indication expansion efforts: Clinical trials for other EGFR-driven cancers ongoing but limited success.

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Clinical Efficacy and Adoption Dynamics

Key clinical trials indicate dacomitinib's efficacy is comparable to osimertinib but with higher toxicity, impacting its adoption rate.

• ARCHER 1050 trial results:
  • Median progression-free survival (PFS): 14.7 months vs 9.2 months for gefitinib.
  • Overall survival (OS): 27.5 months vs. 24.3 months.
  • Higher adverse events: rash, diarrhea, dry skin.

Drug adoption is constrained by safety profile, leading oncologists to prefer osimertinib, which has a more favorable side-effect profile.

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Sales and Revenue Trends

Global sales for dacomitinib have been modest to date.

Year	Estimated Sales (USD millions)	Market Share in EGFR Inhibitors
2018	15	2%
2019	20	2.5%
2020	25	3%
2021	30	3.5%

The growth rate remains capped by limited clinical differentiation and competition from more tolerated agents. Future sales may accelerate if new indications gain regulatory approval or if combination therapies improve efficacy.

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Growth Drivers and Challenges

Growth Drivers

• Expansion into second-line and other NSCLC patient subsets.
• Clinical trials exploring combinations with immunotherapies.
• Potential indication expansion into other EGFR-driven cancers.

Challenges

• Competition from osimertinib and other EGFR inhibitors.
• Toxicity profile limiting widespread use.
• Patent expiration risks around 2025-2027.
• Limited marketing reach as a second-line agent in regions where osimertinib is dominant.

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Financial Outlook

Projected revenues hinge on several factors:

• Market penetration: Minimal currently but may scale with new approvals.
• Patent lifecycle: Limited upside beyond 2027 without approval for additional indications.
• Pricing dynamics: Standard EGFR inhibitor pricing (~USD 10,000–USD 15,000 per year in the U.S.).

Assuming modest market share increases and stable pricing, revenue forecasts remain conservative:

Year	Revenue Estimate (USD millions)	Growth Rate
2022	35	16.7%
2023	45	28.6%
2024	55	22.2%
2025	60	9.1%

Post-patent expiry, revenue decline is expected unless brand extensions or indications are approved.

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Key Takeaways

• Dacomitinib is a late entrant with limited market penetration compared to established competitors, primarily osimertinib.
• Its clinical efficacy is comparable but toxicity limits uptake.
• Revenue growth remains limited, with a peak around 2025, before patent expiration risks materialize.
• Future market expansion relies on additional indications, improved formulations, or combination therapies.
• The patent horizon and competitive landscape heavily influence financial projections.

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FAQs

1. What are the primary factors limiting dacomitinib's market share?
Clinical toxicity, competition from osimertinib, and limited indication expansion restrict market share.

2. When is patent expiration expected, and how will it affect revenues?
Patents are expected to expire between 2025 and 2027, leading to generic entry and a sharp revenue decline.

3. Can dacomitinib be used in other cancers?
Research is ongoing, but current approvals are limited to EGFR-mutant NSCLC; expansion prospects are uncertain.

4. How does dacomitinib compare to osimertinib clinically?
Dacomitinib has similar efficacy but higher toxicity, making it less favored in clinical practice.

5. What are the growth prospects beyond 2025?
Growth assumes successful indication expansion, combination therapies, or market niche positioning; otherwise, revenue decline is expected.

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References

1. Grand View Research. "NSCLC Therapeutics Market Size & Trends," 2021.
2. U.S. FDA. "Dacomitinib Approval Announcement," 2018.
3. ClinicalTrials.gov. "Dacomitinib Trials," 2022.
4. IQVIA. "Pharmaceutical Market Data," 2021.