FRUZAQLA Drug Patent Profile

Which patents cover Fruzaqla, and when can generic versions of Fruzaqla launch?

Fruzaqla is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has seventy-six patent family members in thirty-seven countries.

The generic ingredient in FRUZAQLA is fruquintinib. One supplier is listed for this compound. Additional details are available on the fruquintinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Fruzaqla

Fruzaqla will be eligible for patent challenges on November 8, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 23, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FRUZAQLA

International Patents:	76
US Patents:	4
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FRUZAQLA

FRUZAQLA is protected by four US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No			Y	Y

International Patents for FRUZAQLA

When does loss-of-exclusivity occur for FRUZAQLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Malaysia

Mexico

New Zealand

Philippines

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FRUZAQLA around the world.

Country	Patent Number	Title	Estimated Expiration
China	111018846
Denmark	3191475
Spain	2819242

Supplementary Protection Certificates for FRUZAQLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3191475	CR 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625
3191475	47/2024	Austria		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 (MITTEILUNG) 20240625
3191475	CA 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625

FRUZAQLA (Fruquintinib) Investment Fundamentals Analysis

Last updated: February 19, 2026

This report analyzes the investment fundamentals of FRUZAQLA (fruquintinib), a novel oral tyrosine kinase inhibitor, focusing on its market potential, competitive landscape, and regulatory standing for investors evaluating R&D and commercialization prospects.

What is FRUZAQLA's Mechanism of Action and Targeted Indications?

FRUZAQLA is an orally administered, potent, selective inhibitor of vascular endothelial growth factor receptor (VEGFR) tyrosine kinases, including VEGFR-1, -2, and -3. It targets tumor angiogenesis by inhibiting the signaling pathways that drive the formation of new blood vessels essential for tumor growth and metastasis.

The primary approved indication for FRUZAQLA is for patients with previously treated metastatic colorectal cancer (mCRC). This includes patients who have received prior standard chemotherapy (such as fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy), anti-VEGF therapy, and anti-EGFR therapy (if RAS wild-type). [1, 2]

What is FRUZAQLA's Clinical Efficacy Data in mCRC?

Clinical trials demonstrate FRUZAQLA's efficacy in heavily pre-treated mCRC patients. The pivotal Phase III FRESCO trial, conducted in China, showed a statistically significant improvement in overall survival (OS).

• FRESCO Trial Results:
  • Median Overall Survival: 9.3 months for FRUZAQLA arm versus 6.2 months for placebo arm. (Hazard Ratio [HR] 0.67; 95% Confidence Interval [CI] 0.52-0.86; P=0.0019). [2]
  • Median Progression-Free Survival (PFS): 3.7 months for FRUZAQLA arm versus 1.7 months for placebo arm. (HR 0.45; 95% CI 0.34-0.59; P<0.0001). [2]
  • Objective Response Rate (ORR): 4.1% for FRUZAQLA arm versus 0% for placebo arm. [2]
  • Disease Control Rate (DCR): 71.4% for FRUZAQLA arm versus 47.7% for placebo arm. [2]

Subsequent analyses and real-world evidence have further supported these findings in patient populations with specific genetic mutations, such as KRAS wild-type. [3]

What is FRUZAQLA's Regulatory Status and Approvals?

FRUZAQLA has received regulatory approvals in key markets, enabling its commercialization.

• United States: Approved by the U.S. Food and Drug Administration (FDA) in November 2023 for adult patients with metastatic colorectal cancer (mCRC) who have received prior treatment with a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy (if RAS wild-type). [1, 4]
• China: Approved by the China National Medical Products Administration (NMPA) in 2017 for mCRC. [5]
• European Union: Submitted for regulatory review. [6]

What is the Market Landscape for FRUZAQLA in mCRC?

The mCRC market is characterized by multiple treatment lines and a range of therapeutic options, including chemotherapy, targeted therapies, and immunotherapies. FRUZAQLA is positioned as a later-line treatment option.

• Key Competitors and Treatment Modalities in Later-Line mCRC:
  • Regorafenib (Stivarga): A multi-kinase inhibitor approved for previously treated mCRC. [7]
    • Phase III CORRECT trial showed median OS of 6.4 months versus 5.0 months for placebo (HR 0.77; P=0.0052). [8]
  • Trifluridine/tipiracil (LONSURF): An oral nucleoside analog combination approved for previously treated mCRC. [9]
    • Phase III RECOURSE trial showed median OS of 7.1 months versus 5.3 months for placebo (HR 0.69; P=0.00007). [10]
  • Biologic Therapies (e.g., Cetuximab, Panitumumab): Primarily used in earlier lines for RAS wild-type patients, but may have limited roles in later lines depending on prior treatment.
  • Emerging Therapies: Ongoing research explores novel agents and combinations.

FRUZAQLA's efficacy in a heavily pre-treated population, as demonstrated in the FRESCO trial, places it as a direct competitor to existing later-line therapies like regorafenib and trifluridine/tipiracil. Its oral administration offers convenience.

What are FRUZAQLA's Key Differentiating Factors and Competitive Advantages?

FRUZAQLA offers several potential advantages within its target market.

• Potent and Selective VEGFR Inhibition: Its specific mechanism of action targets angiogenesis, a critical process in CRC progression.
• Demonstrated Survival Benefit: The FRESCO trial provided robust data on OS improvement in a challenging patient population.
• Oral Administration: Enhances patient convenience and potentially reduces healthcare resource utilization compared to intravenous therapies.
• Broad Approval Basis: Approved in China and the US for mCRC, with broader indications potentially in development.

What are the Potential Risks and Challenges for FRUZAQLA?

Several factors could influence FRUZAQLA's market penetration and commercial success.

• Safety Profile: Like other VEGFR inhibitors, FRUZAQLA is associated with side effects. Common adverse events include hypertension, hand-foot skin reaction, fatigue, and diarrhea. Management of these toxicities is crucial for patient adherence and treatment success. [1, 2]
• Market Competition: The mCRC landscape is crowded, with established players and ongoing development of new therapies. Demonstrating clear superiority or a distinct value proposition will be key.
• Reimbursement and Payer Access: Securing favorable reimbursement and market access from payers globally will be critical for broad adoption. Pricing strategies will need to balance efficacy with affordability.
• Pipeline Expansion: Future growth potential will depend on the success of ongoing and planned clinical trials for FRUZAQLA in other indications or earlier lines of therapy.

What are FRUZAQLA's Commercialization Strategy and Partnerships?

The commercialization strategy for FRUZAQLA involves strategic partnerships.

• Hutchmed (China): The original developer and marketer of FRUZAQLA in China. [5]
• Eli Lilly and Company (Global Ex-China): Eli Lilly entered into a collaboration with Hutchmed for the development and commercialization of FRUZAQLA outside of China. This partnership provides global reach, R&D expertise, and established commercial infrastructure. [4, 6] This collaboration is central to FRUZAQLA's global market entry.

What is FRUZAQLA's Potential for Expansion into Other Indications?

While currently approved for mCRC, FRUZAQLA is being investigated in other oncology indications, which could significantly expand its market potential.

• Ongoing Clinical Trials:
  • Gastric Cancer: FRUZAQLA is being evaluated in Phase III trials for advanced gastric/gastroesophageal junction adenocarcinoma. [11]
  • Lung Cancer: Investigational studies are underway for non-small cell lung cancer (NSCLC). [12]
  • Other Solid Tumors: Preclinical and early-stage clinical investigations are exploring its role in other tumor types.

Successful development in these additional indications would broaden FRUZAQLA's therapeutic utility and market size.

Key Takeaways

FRUZAQLA (fruquintinib) presents a compelling investment case as a targeted therapy for previously treated metastatic colorectal cancer, supported by robust clinical data demonstrating a significant overall survival benefit. Its oral administration offers patient convenience. The strategic partnership with Eli Lilly provides global commercialization capabilities. Key risks include managing its safety profile, navigating a competitive market, and securing broad reimbursement. Future growth hinges on successful expansion into other oncology indications currently under investigation, particularly gastric and lung cancers.

Frequently Asked Questions

What is the primary endpoint of the FRESCO trial for FRUZAQLA?

The primary endpoint of the FRESCO trial was overall survival (OS).

What is the recommended dosage for FRUZAQLA in the US?

The recommended dosage of FRUZAQLA is 5 mg orally once daily.

Does FRUZAQLA have any specific contraindications?

FRUZAQLA is contraindicated in patients with known hypersensitivity to fruquintinib or any of its excipients.

How does FRUZAQLA's safety profile compare to other oral VEGFR inhibitors?

FRUZAQLA shares a similar safety profile to other oral VEGFR inhibitors, with common adverse events including hypertension, hand-foot skin reaction, fatigue, and diarrhea. Dose modifications or interruptions may be required to manage these toxicities.

What is the anticipated market size for FRUZAQLA in its current indication?

Estimates vary, but the market for later-line mCRC treatments is substantial, with significant unmet needs. The global market for colorectal cancer therapeutics is projected to grow, and FRUZAQLA's efficacy in a heavily pre-treated population positions it to capture a meaningful share.

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Citations

[1] U.S. Food and Drug Administration. (2023, November 17). FDA approves fruquintinib tablets for adults with metastatic colorectal cancer. FDA. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-tablets-adults-metastatic-colorectal-cancer

[2] Qin, S., Chen, L., Wu, D., Cheng, Y., Shen, L., Jin, S., Wu, J., Wang, H., Xu, J., Jiang, J., Cai, Z., Zhao, S., Wang, X., Chen, Y., Gu, J., Hu, D., Li, J., Ma, W., Yu, Z., … Wang, J. (2019). Fruquintinib vs. placebo in patients with previously treated, refractory metastatic colorectal cancer: The FRESCO randomized clinical trial. JAMA Oncology, 5(3), 379–387. https://doi.org/10.1001/jamaoncol.2018.5978

[3] Wu, B., Yang, C., Li, Y., Li, G., Xu, J., Lin, Q., Li, X., Li, Z., Wang, X., Liu, S., Song, S., Li, J., Wu, S., Chen, P., Zhang, Q., Ding, J., Cui, J., & Chinese Society of Clinical Oncology (CSCO) Guidelines Committee. (2021). Efficacy and Safety of Fruquintinib in Chinese Patients With Metastatic Colorectal Cancer: A Real-World Study. Frontiers in Oncology, 11, 755580. https://doi.org/10.3389/fonc.2021.755580

[4] Eli Lilly and Company. (2023, November 17). FDA approves fruquintinib, an oral VEGFR inhibitor, for previously treated metastatic colorectal cancer. Eli Lilly and Company. https://investor.lilly.com/news-releases/news-release-details/fda-approves-fruquintinib-oral-vegfr-inhibitor-previously-treated

[5] Hutchison China MediTech Limited. (2017). HUTCHMED announces NMPA approval of fruquintinib for metastatic colorectal cancer in China. Hutchison China MediTech Limited. https://www.hutch-med.com/wp-content/uploads/2023/05/HUTCHMED-Announces-NMPA-Approval-of-Fruquintinib-for-Metastatic-Colorectal-Cancer-in-China.pdf

[6] Eli Lilly and Company. (2023, February 22). Eli Lilly and Company and Hutchmed announce submission of new drug application for fruquintinib in the European Union. Eli Lilly and Company. https://investor.lilly.com/news-releases/news-release-details/eli-lilly-and-company-and-hutchmed-announce-submission-new-drug

[7] Bayer AG. (n.d.). Stivarga (regorafenib) tablets. Bayer AG. Retrieved from https://www.stivarga.com/

[8] Schmoll, H. J., Van Cutsem, E., Stein, A.,ellate, R., Ambinder, E. P., Siena, S., Huitema, A. D. R., van Krieken, H. H., Wichert, R., & Hoff, P. M. (2015). Regorafenib for previously treated metastatic colorectal cancer: the randomized, double-blind, Phase 3 CORRECT trial. The Lancet, 385(9978), 1727–1736. https://doi.org/10.1016/S0140-6736(14)62429-8

[9] Taiho Pharmaceutical Co., Ltd. (n.d.). LONSURF® (trifluridine/tipiracil) tablets. Taiho Pharmaceutical Co., Ltd. Retrieved from https://www.lonsurf.com/

[10] Tabernero, J., Yoshino, T., Chao, Y., Shapiro, J., Rosen, L. S., Scheithauer, W., He, D., Kanzaki, A., Kim, S. B., Zhang, W., Mascheroni, S., Lønnecken, A., Miller, E., Wagle, K., & Hoff, P. M. (2015). Trifluridine/tipiracil versus placebo in previously treated patients with metastatic colorectal cancer (RECOURSE): a randomised, controlled, open-label, Phase 3 trial. The Lancet Oncology, 16(11), 1255–1267. https://doi.org/10.1016/S1470-2045(15)00203-7

[11] Hutchison China MediTech Limited. (2023, May 2). HUTCHMED announces updated clinical development plans for fruquintinib. Hutchison China MediTech Limited. https://www.hutch-med.com/wp-content/uploads/2023/05/HUTCHMED-Announces-Updated-Clinical-Development-Plans-for-Fruquintinib.pdf

[12] Li, L., Sun, J., Wang, H., Jiang, L., Fu, P., Xie, Z., Li, D., Zhao, J., Xu, Y., Li, Y., & Li, X. (2020). A Phase Ib study of fruquintinib in combination with toripalimab in patients with advanced refractory non-small cell lung cancer. Journal of Clinical Oncology, 38(15_suppl), e21022–e21022. https://doi.org/10.1200/JCO.2020.38.15_suppl.e21022