Dacomitinib Patent Expiration

Dacomitinib is used for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It was first introduced by Pfizer Inc in its drug Vizimpro on Sep 27, 2018.


Dacomitinib Patents

Given below is the list of patents protecting Dacomitinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vizimpro US7772243 4-phenylamino-quinazolin-6-yl-amides Sep 27, 2032 Pfizer
Vizimpro US10596162 Method for treating gefitinib resistant cancer Feb 02, 2026

(Expired)

Pfizer
Vizimpro US10603314 Method for treating gefitinib resistant cancer Feb 02, 2026

(Expired)

Pfizer
Vizimpro US8623883 4-phenylamino-quinazolin-6-yl-amides May 05, 2025

(Expired)

Pfizer



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dacomitinib's patents.

Given below is the list recent legal activities going on the following patents of Dacomitinib.

Activity Date Patent Number
Patent litigations
Expire Patent 09 Feb, 2026 US8623883
Patent Term Extension Certificate 26 Nov, 2025 US7772243
Patent Term Extension Certificate 14 Nov, 2025 US7772243
Maintenance Fee Reminder Mailed 25 Aug, 2025 US8623883
Notice of Final Determination -Eligible 09 May, 2025 US7772243
Notice of Final Determination -Eligible 31 Jan, 2025 US7772243
FDA Final Eligibility Letter 13 Jan, 2025 US7772243
transaction for FDA Determination of Regulatory Review Period 28 Dec, 2023 US7772243
transaction for FDA Determination of Regulatory Review Period 08 Dec, 2023 US7772243
Payment of Maintenance Fee, 4th Year, Large Entity 13 Sep, 2023 US10603314(Litigated)


Dacomitinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Dacomitinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study Region Skane NA RECRUITING
(May 1, 2026)
PHASE3
HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease MedSIR NA COMPLETED
(Apr 1, 2026)
PHASE2


Dacomitinib Generic API Manufacturers

Given below is the list of companies who have filed for Dacomitinib generic, along with the locations of their manufacturing plants worldwide.