Tucatinib Patent Expiration

Tucatinib is Used for treating advanced or metastatic colorectal cancer and breast cancer that is HER2-positive or overexpressing. It was first introduced by Seagen Inc in its drug Tukysa on Apr 17, 2020.


Tucatinib Patents

Given below is the list of patents protecting Tucatinib, 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
Tukysa US11207324 Treatment of HER2 positive cancers Apr 27, 2038 Seagen
Tukysa US11666572 Treatment of HER2 positive cancers Apr 27, 2038 Seagen
Tukysa US12048698 Treatment of HER2 positive cancers Apr 27, 2038 Seagen
Tukysa US8648087 N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases Apr 17, 2034 Seagen
Tukysa US11504370 Treatment of brain cancer Mar 25, 2033 Seagen
Tukysa US9457093 Solid dispersions of a ERB2 (HER2) inhibitor Oct 12, 2032 Seagen
Tukysa US9693989 N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases May 09, 2027 Seagen
Tukysa US7452895 Quinazoline analogs as receptor tyrosine kinase inhibitors Nov 16, 2026 Seagen



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 Tucatinib's patents.

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

Activity Date Patent Number
Patent litigations
Notice of Final Determination -Election Required 03 Mar, 2026 US8648087
37 CFR 1.750 Request for reconsideration 12 Feb, 2026 US8648087
Terminal Disclaimer Filed 02 Feb, 2026 US8648087
Withdrawal of Application for PTE 16 Jan, 2026 US7452895
Notice of Final Determination -Election Required 16 Jan, 2026 US9693989
Notice of Final Determination -Election Required 16 Jan, 2026 US8648087
Notice of Final Determination -Election Required 16 Jan, 2026 US9457093
Withdrawal of Application for PTE 15 Jan, 2026 US7452895
Interim Patent Term Extension Granted 12 Nov, 2025 US7452895
Requirement for information sent under 37 CFR 1.750 19 Sep, 2025 US7452895


Tucatinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tucatinib:

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
PRE-ISPY Phase I/II Oncology Platform Program QuantumLeap Healthcare Collaborative NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer Seagen, a wholly owned subsidiary of Pfizer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Seagen, a wholly owned subsidiary of Pfizer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer Seagen, a wholly owned subsidiary of Pfizer NA RECRUITING
(Jul 1, 2026)
PHASE3
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors Seagen, a wholly owned subsidiary of Pfizer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Merck Sharp & Dohme LLC NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer Seagen, a wholly owned subsidiary of Pfizer NA COMPLETED
(Mar 1, 2026)
PHASE2
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib Carey Anders, M.D. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC Criterium, Inc. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer SCRI Development Innovations, LLC NA RECRUITING
(Mar 1, 2026)
PHASE2


Tucatinib Generic API Manufacturers

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