Crizotinib Patent Expiration

Crizotinib is used for treating ALK-positive inflammatory myofibroblastic tumors, metastatic non-small cell lung cancer, and relapsed or refractory systemic anaplastic large cell lymphoma in pediatric and young adult patients over 1 year of age. It was first introduced by Pf Prism Cv in its drug Xalkori on Aug 26, 2011.


Crizotinib Patents

Given below is the list of patents protecting Crizotinib, 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
Xalkori US8217057 Polymorphs of a c-MET/HGFR inhibitor Nov 06, 2029 Pf Prism Cv
Xalkori US7858643 Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Oct 08, 2029 Pf Prism Cv
Xalkori US7825137 Method of treating abnormal cell growth May 12, 2027 Pf Prism Cv
Xalkori US7230098 Aminoheteroaryl compounds as protein kinase inhibitors Aug 26, 2025

(Expired)

Pf Prism Cv
Xalkori US8785632 Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Mar 01, 2025

(Expired)

Pf Prism Cv



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 Crizotinib's patents.

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

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 09 Mar, 2026 US8785632
Payment of Maintenance Fee, 12th Year, Large Entity 14 Dec, 2023 US8217057
Payment of Maintenance Fee, 12th Year, Large Entity 11 May, 2022 US7858643
Payment of Maintenance Fee, 12th Year, Large Entity 12 Apr, 2022 US7825137
Payment of Maintenance Fee, 8th Year, Large Entity 09 Dec, 2021 US8785632
Payment of Maintenance Fee, 8th Year, Large Entity 18 Dec, 2019 US8217057
Payment of Maintenance Fee, 12th Year, Large Entity 15 Nov, 2018 US7230098
Payment of Maintenance Fee, 8th Year, Large Entity 09 May, 2018 US7858643
Payment of Maintenance Fee, 8th Year, Large Entity 13 Apr, 2018 US7825137
Payment of Maintenance Fee, 4th Year, Large Entity 15 Dec, 2017 US8785632


Crizotinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Crizotinib:

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
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ROS1 Genetic Changes (MATCH-Subprotocol G) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) Bristol-Myers Squibb NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Phase III Study to Evaluate the Efficacy and Safety of JYP0322 in Previously Untreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Guangzhou JOYO Pharma Co., Ltd NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma IDEAYA Biosciences NA RECRUITING
(Aug 1, 2026)
PHASE3
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement Yonsei University NA COMPLETED
(Jul 1, 2026)
PHASE2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Hoffmann-La Roche NA COMPLETED
(Jun 1, 2026)
PHASE3
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer Hoffmann-La Roche NA COMPLETED
(Jun 1, 2026)
PHASE3
Study of Crizotinib for ROS1 and MET Activated Lung Cancer University Health Network, Toronto NA COMPLETED
(Jun 1, 2026)
PHASE2
Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC) Megan Kruse, MD NA SUSPENDED
(Jun 1, 2026)
PHASE2
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants Hoffmann-La Roche NA COMPLETED
(May 1, 2026)
PHASE3
Testing Crizotinib as a Potential Targeted Treatment in Cancers With ALK Genetic Changes (MATCH-Subprotocol F) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer CStone Pharmaceuticals NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer University of Birmingham NA COMPLETED
(Apr 1, 2026)
PHASE2
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. Sun Yat-sen University NA RECRUITING
(Apr 1, 2026)
PHASE2
A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Nuvation Bio Inc. NA RECRUITING
(Apr 1, 2026)
PHASE3
Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa) China Medical University Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Genetic Changes (MATCH - Subprotocol C1) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2


Crizotinib Generic API Manufacturers

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