Fruquintinib Patent Expiration

Fruquintinib is Used for the treatment of metastatic colorectal cancer that is resistant to multiple chemotherapies and targeted therapies. It was first introduced by Takeda Pharmaceuticals Usa Inc in its drug Fruzaqla on Nov 8, 2023.


Fruquintinib Patents

Given below is the list of patents protecting Fruquintinib, 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
Fruzaqla US10519142 Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide Sep 07, 2035 Takeda Pharms Usa
Fruzaqla US11046674 Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-N,2-dimethylbenzofuran-3-carboxamide Sep 07, 2035 Takeda Pharms Usa
Fruzaqla US7829574 Substituted quinazoline compounds and their use in treating angiogenesis-related diseases Mar 23, 2032 Takeda Pharms Usa
Fruzaqla US8212033 Use of substituted quinazoline compounds in treating angiogenesis-related diseases May 09, 2028 Takeda Pharms Usa



Fruquintinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Fruquintinib:

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
Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma RenJi Hospital NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Phase II Study of Irinotecan Liposome Plus Fruquintinib and Sintilimab in Second-Line PD-L1-Positive Advanced Gastric Cancer Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer Criterium, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE2
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer Innovent Biologics (Suzhou) Co. Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors Sapience Therapeutics NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors. Fudan University NA RECRUITING
(Jul 1, 2026)
PHASE2
Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Tianjin Medical University Cancer Institute and Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma Shanghai 6th People's Hospital NA SUSPENDED
(Jun 1, 2026)
PHASE2
Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma Sichuan University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cancer Shanghai Zhongshan Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer National Cancer Center Hospital East NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases Shandong Cancer Hospital and Institute NA RECRUITING
(Mar 1, 2026)
PHASE2
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Chipscreen Biosciences, Ltd. NA RECRUITING
(Mar 1, 2026)
PHASE3
Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma Sun Yat-sen University NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Fruquintinib In Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies in South Korea Patients (FIRST-K) Korea University Anam Hospital NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2
SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study Meng Qiu NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Fruquintinib Generic API Manufacturers

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