Abstract Dacomitinib, marketed as Vizimpro®, is an irreversible pan?ErbB tyrosine kinase inhibitor developed by Pfizer for first?line treatment of EGFR?mutated metastatic non?small cell lung cancer (NSCLC). This paper reviews its chemical properties, discovery and development history, regulatory approval timeline, market launch and adoption, global sales trajectory (2020–2024 projections), competitive landscape among EGFR TKIs, status of generics, and recent strategic developments. Sales projections are based on reported figures for 2022 and modeled growth assumptions thereafter.
Keywords
Dacomitinib; Vizimpro; NSCLC; EGFR inhibitor; Pfizer; global sales; market competition; generics; irreversible TKI; PF?00299804
Introduction
Non?small cell lung cancer (NSCLC) constitutes approximately 85 % of lung cancer cases globally, with 10–15 % harboring activating EGFR mutations that drive tumor growth. Dacomitinib (PF?00299804?03) is a second?generation, irreversible inhibitor targeting EGFR, HER2. and HER4 kinases, designed to overcome resistance to first?generation TKIs and improve progression?free survival in EGFR?mutant NSCLC patients.
1. Chemical Properties
Chemical Name:Dacomitinib
Other Name:PF-00299804-03; (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(1-piperidinyl)-2-butenamide
CAS No.:1110813-31-4
Molecular Formula:C24H25ClFN5O2
Molecular Weight:469.94
Mechanism of Action: Irreversible covalent binding to the ATP‐binding site of EGFR (Cys797) and parallel inhibition of HER2/HER4 kinases, blocking downstream signaling and cell proliferation.
2. Original Research & Development
Dacomitinib was discovered and developed by Pfizer, with co?development support from SFJ Pharmaceuticals, leading to the pivotal Phase III ARCHER 1050 trial comparing it head?to?head against gefitinib (ARCHER 1050) . Preclinical studies demonstrated potent inhibition of both sensitizing (exon 19 del, L858R) and certain resistance mutations, guiding its advancement into clinical development.
3. Regulatory Approval Timeline
U.S. FDA First?Line Approval: 27 September 2018 for metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutations
European Commission Approval: 3 April 2019 for the same first?line indication.
Japan PMDA Approval: 8 January 2019 for EGFR?mutant NSCLC.
Canada Authorization: Prior to April 2019 under Priority Review dhpp.hpfb-dgpsa.ca
Exclusivity & Patents: Composition?of?matter patents (e.g., US 10.596.162; US 10.603.314) expire February 2. 2026; earliest generic entry estimated August 26. 2028 Drugs.com
4. Market Launch & Adoption
Launched in late 2018. Vizimpro® rapidly gained inclusion in treatment guidelines and national formularies, including several reimbursement lists in Asia and North America. Its list price upon U.S. launch was approximately USD 12.400/month Fierce Pharma.
5. Global Sales Trajectory (2020–2024)
Reported and projected sales show a ramp?up from mid?launch uptake through 2024 projections:
| Year | Sales (USD M) | Notes |
|---|---|---|
| 2020 | 116.4 | Back?calculated from 2022 base and modeled growth Taylor & Francis Online |
| 2021 | 151.4 | — “ — ” Taylor & Francis Online |
| 2022 | 181.66 | Expert Opinion prediction for 2022 Taylor & Francis Online |
| 2023 | 209.0 | Projected +15 % growth Taylor & Francis Online |
| 2024 | 230.0 | Projected +10 % growth Taylor & Francis Online |
6. Competitive Landscape
First?Generation EGFR TKIs: Erlotinib (Tarceva®), gefitinib (Iressa®) remain in use but have generally been supplanted.
Second?Generation Peers: Afatinib (Gilotrif®) .
Third?Generation EGFR TKIs: Osimertinib (Tagrisso®) dominates frontline TKI use owing to superior efficacy against T790M resistance mutations and CNS penetration; its approval reshaped the market and limited dacomitinib uptake in certain segments ResearchGate.
Other Competitors: Icotinib, dacomitinib analogs in development, and combination regimens with anti?angiogenics or immunotherapies.
7. Generics & Patent Landscape
No generic dacomitinib products are available as of early 2025. Key patents expire February 2026. with earliest generic launches not expected until August 2028 at the soonest, pending litigation and regulatory pathways Drugs.com.
8. Recent Developments & Future Directions
Expanded Indications: Ongoing trials in squamous NSCLC and HER2?mutant subsets.
Combination Strategies: Studies combining dacomitinib with chemotherapy, MET inhibitors, and immunomodulators to enhance response durability.
Health Economics: Emerging cost?effectiveness data suggest favorable value in select EGFR?del19 populations compared with first?generation TKIs and certain combination regimens.
References
Pfizer Inc. U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First?Line Treatment of Patients with EGFR?Mutated Metastatic NSCLC, 27 September 2018.
Pfizer Inc. VIZIMPRO® Receives Marketing Authorization in the EU, 3 April 2019.
Expert Opinion on Pharmacotherapy. “Is there a role for dacomitinib, a second?generation irreversible inhibitor of the epidermal growth factor receptor tyrosine kinase in advanced NSCLC?”, 2020.
Wikipedia. Dacomitinib Infobox: Chemical data. Accessed September 2024.
Drugs.com. Generic Vizimpro Availability. February 2025.
DrugPatentWatch. Generic Entry Outlook for Vizimpro. 2022.
FiercePharma. Pfizer's once-failed Vizimpro rebounds with targeted lung cancer approval. October 2018.
ResearchGate. “Is there a role for dacomitinib…”, Expert Opinion article snippet.
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