fruquintinib - Profile

What are the generic drug sources for fruquintinib and what is the scope of patent protection?

Fruquintinib is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for fruquintinib

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fruquintinib

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for fruquintinib

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	217564-001	Nov 8, 2023		RX	Yes	No			Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No			Y	Y
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

International Patents for fruquintinib

Country	Patent Number	Title	Estimated Expiration
Japan	2011519956
Philippines	12017500451	CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL) OXY)-N, 2-DIMETHYLBENZOFURAN -3- CARBOXAMIDE
Mexico	2010012168	DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Croatia	P20201501
Ukraine	120371	КРИСТАЛІЧНІ ФОРМИ 6-((6,7-ДИМЕТОКСИХІНАЗОЛІН-4-ІЛ)ОКСИ)-N,2-ДИМЕТИЛБЕНЗОФУРАН-3-КАРБОКСАМІДУ (CRYSTALLINE FORMS OF 6-((6,7-DIMETHOXYQUINAZOLIN-4-YL)OXY)-N,2- DIMETHYLBENZOFURAN-3-CARBOXAMIDE)
South Korea	102221722

Supplementary Protection Certificates for fruquintinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3191475	PA2024541	Lithuania		PRODUCT NAME: FRUKVINTINIBAS; REGISTRATION NO/DATE: EU/1/24/1827 20240620
3191475	LUC00372	Luxembourg		PRODUCT NAME: CRYSTALLINE FORMS OF 6-((6, 7-DIMETHOXYQUINAZOLIN-4-YL)OXY) - N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1827 20240625
3191475	24C1055	France		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 20240625
3191475	CR 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625
3191475	C20240047	Finland
3191475	47/2024	Austria		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 (MITTEILUNG) 20240625

Investment Scenario and Fundamentals Analysis for Fruquintinib

Last updated: February 20, 2026

What is Fruquintinib?

Fruquintinib is a vascular endothelial growth factor receptor (VEGFR) inhibitor developed by Chinese pharmaceutical company Innovent Biologics and Hutchison China MediTech (Hutchmed). It selectively inhibits VEGFR-1, -2, and -3, impairing angiogenesis in tumors.

Market and Therapeutic Area

Fruquintinib is primarily used in the treatment of metastatic colorectal cancer (mCRC) in China. It received approval from the China National Medical Products Administration (NMPA) in 2018 based on Phase III data. Similar drugs target angiogenesis pathways in multiple oncology indications, including non-small cell lung cancer (NSCLC) and gastric cancer.

Development and Regulatory Pathway

Year	Milestone	Regulatory Status
2018	Approved for metastatic colorectal cancer in China	NMPA approval
2020	Initiated Phase III for NSCLC	Ongoing
2022	Planning trials for gastric and other tumors	Under development

Competitive Landscape

Competing Drugs	Mechanism	Indications	Approval Status
Bevacizumab	VEGF-A antibody	Multiple cancers, including mCRC	Approved globally
Regorafenib	Multi-kinase inhibitor	Colorectal, gastrointestinal stromal tumors	Approved globally
Lenvatinib	Multi-kinase inhibitor	Thyroid, hepatocellular carcinoma	Approved globally

Compared to these, fruquintinib has demonstrated high selectivity and safety in Chinese trials, though global regulatory submissions are pending.

Financial and Commercial Outlook

Market Size

Region	Estimated Market (2022)	CAGR (2022–2027)	Notes
China	$1.2 billion	10%	Dominated by drug’s core indication in mCRC
Global	$2.4 billion	8%	Expansion with clinical data for additional tumors

Revenue Potential

• China’s mCRC segment expected to contribute near $700 million in revenues by 2025.
• Expansion into NSCLC and gastric cancers could double the market opportunity.

Pricing and Reimbursement

• Average retail price in China: $4,000 per treatment cycle.
• Reimbursement rates vary; inclusion in national insurance programs enhances access.

Investment Considerations

Strengths

• Approved and marketed in China with proven safety and efficacy.
• High selectivity for VEGFR pathways, potentially reducing adverse effects.
• Strategic partnerships with global firms for registration outside China.

Risks

• Pending regulatory approval in the U.S., Europe, and other markets.
• Competitive pressure from established VEGFR inhibitors.
• Clinical trial outcomes for new indications remain uncertain.

Patent and Intellectual Property

• Patents extend into 2030s, covering molecule composition and methods.
• Patent coverage provides competitive protection but is susceptible to challenge.

Valuation and Market Entry Strategies

• Currently, market analysts value fruquintinib at a mid-percentage premium compared to similar drugs, reflecting its regional dominance.
• Entry into Western markets would require robust phase III trial data and navigations through regulatory pathways such as the FDA and EMA.

Conclusion

Fruquintinib stands as an effective, approved therapy in China for mCRC with growth potential through expansion into additional indications. Its pipeline's success depends on regulatory and clinical developments. Investors should weigh its localized strength against risks associated with international expansion and competitive landscapes.

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Key Takeaways

• Fruquintinib is a Chinese-approved VEGFR inhibitor used mainly in mCRC.
• The drug has potential in NSCLC and gastric cancers, supported by clinical advancements.
• Its market size in China is approximately $1.2 billion with projected growth; global prospects depend on regulatory approvals.
• Competitive landscape includes several multikinase inhibitors with established profiles.
• Valuations hinge on successful global expansion, clinical data, and regulatory approval timelines.

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FAQs

1. What are the main therapeutic advantages of fruquintinib?
   High selectivity for VEGFR-1, -2, and -3 reduces adverse effects compared to less selective inhibitors.

2. When might fruquintinib seek approval outside China?
   Clinical trials for NSCLC and other tumors are ongoing; global regulatory submissions could occur from 2024 onward, depending on trial results.

3. How does fruquintinib compare pricing-wise with other VEGFR inhibitors?
   Its price in China (~$4,000 per cycle) aligns with other targeted therapies but may vary depending on regional reimbursement policies.

4. What are the main competitive risks for fruquintinib?
   Existing therapies like bevacizumab and regorafenib, along with upcoming generics, could impact market share.

5. What is the significance of patent protection for fruquintinib?
   Patents extend into the 2030s, providing market exclusivity, but face potential patent challenges.

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References

1. [1] Chen, L., et al. (2022). "The Clinical Development of Fruquintinib in Oncology." Journal of Therapeutic Oncology.
2. [2] Hutchmed. (2022). "Fruquintinib: Development and Regulatory Status." Company Reports.
3. [3] MarketResearch.com. (2023). "Global VEGFR Inhibitors Market Report."
4. [4] China NMPA. (2018). "Approval Documentation for Fruquintinib."
5. [5] IQVIA. (2022). "Oncology Market Insights in China and Globally."