Fruquintinib - Generic Drug Details

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-three patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for fruquintinib

International Patents:	73
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	84
Patent Applications:	139
What excipients (inactive ingredients) are in fruquintinib?	fruquintinib excipients list
DailyMed Link:	fruquintinib at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for fruquintinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking University	N/A
Zhejiang Cancer Hospital	Phase 1/Phase 2
Fudan University	N/A

See all fruquintinib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fruquintinib

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	217564-002	Nov 8, 2023		RX	Yes	Yes
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	8,212,033
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	7,829,574		Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	10,519,142		Y	Y
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No	11,046,674
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-001	Nov 8, 2023		RX	Yes	No	8,212,033
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes	11,046,674

International Patents for fruquintinib

Country	Patent Number	Title	Estimated Expiration
Cyprus	1123892
Singapore	11201701544U	CRYSTALLINE FORMS OF 6- ( (6, 7-DIMETHOXYQUINAZOLIN-4-YL) OXY) -N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE
South Korea	20170042662	6--N,2-디메틸벤조푸란-3-카르복사미드의 결정형 (6-67--4--N2--3- Crystalline forms of 6-67-dimethoxyquinazolin-4-yloxy-N2-dimethylbenzofuran-3-carboxamide)
World Intellectual Property Organization (WIPO)	2016037550
Israel	250647	צורות קריסטליות של 6-((6, 7 - דימתוקסיקווינאזולין-4-יל)אוקסי)-n -2 - דימתילבנזופוראן -3- קרבוקסאמיד (Crystalline forms of 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-n,2-dimethylbenzofuran-3-carboxamide)
Mexico	2010012168	DERIVADOS DE QUINAZOLINA. (QUINAZOLINE DERIVATIVES.)
Croatia	P20150954

Supplementary Protection Certificates for fruquintinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3191475	CA 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625
3191475	301307	Netherlands		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	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	PA2024541	Lithuania		PRODUCT NAME: FRUKVINTINIBAS; REGISTRATION NO/DATE: EU/1/24/1827 20240620

Market Dynamics and Financial Trajectory for Fruquintinib

Introduction

Fruquintinib, a small molecule inhibitor of the vascular endothelial growth factor receptors (VEGFRs), has been making significant waves in the pharmaceutical industry, particularly in the oncology segment. Developed by HUTCHMED, this drug has seen substantial commercial success and regulatory approvals in various markets. Here, we delve into the market dynamics and financial trajectory of fruquintinib.

Regulatory Approvals and Market Expansion

Fruquintinib, marketed under the brand name FRUZAQLA® outside of mainland China, Hong Kong, and Macau, has received several key regulatory approvals. It was approved in the US in November 2023, followed by approvals in the EU in June 2024, Switzerland in August 2024, and Canada, Japan, the UK, Argentina, Australia, and Singapore in September and October 2024[1].

Commercial Performance

Since its launch in the US in November 2023, FRUZAQLA® has generated significant revenue. As of the first half of 2024, it has achieved $130.5 million in US sales, contributing to a 59% increase in HUTCHMED's oncology product revenue to $127.8 million[2].

Partnership with Takeda

HUTCHMED's partnership with Takeda has been instrumental in the global commercialization of fruquintinib. Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. This partnership has led to the achievement of a $200 million sales milestone, triggering a $20 million commercial milestone payment to HUTCHMED[1].

Financial Metrics

Revenue

Despite strong oncology product revenue growth, HUTCHMED's total revenue for the first half of 2024 was $305.7 million, down 43% from $532.9 million in the first half of 2023. This decline is largely attributed to lower milestone payments from Takeda compared to the previous year[2].

Net Income

The company reported a net income of $25.8 million for the first half of 2024, a significant decrease from $168.6 million in the first half of 2023[2].

Cash Balance

HUTCHMED maintains a strong cash position of $802.5 million as of June 30, 2024, providing a robust runway for continued research and development (R&D) and commercial investments[2].

Research and Development Expenses

R&D expenses have been reduced by 34% to $95.3 million in the first half of 2024, reflecting the company's efforts to optimize its R&D spending while advancing its pipeline[2].

Market Impact and Competition

Budget Impact Analysis

A budget impact analysis suggests that introducing fruquintinib for its approved indication has a limited budget impact from the US payer perspective, estimated to be well below the proposed threshold from ICER. The analysis indicates a total five-year incremental budget impact of $4,077,373, translating to a per member cost of $0.07 per month and $0.82 per year[4].

Market Share and Competition

Fruquintinib competes with other treatments such as regorafenib and trifluridine/tipiracil. The market share distribution among these comparators is expected to be constant over time, with fruquintinib contributing to prolonged progression-free survival (PFS) and overall survival (OS) compared to the reference scenario without fruquintinib[4].

Future Outlook

Pipeline Progress

HUTCHMED's diverse pipeline, including ongoing trials in endometrial and renal cell carcinoma, offers potential for future growth. The company is also preparing for a potential US NDA filing for savolitinib by the end of 2024[2][3].

Regulatory Landscape

The evolving regulatory landscape, particularly in China, emphasizes the need for robust overall survival data, especially for combination therapies in oncology. This trend is reflected in the NMPA's stance on fruquintinib's supplemental NDA[3].

Key Takeaways

• Regulatory Success: Fruquintinib has received multiple regulatory approvals in key markets.
• Commercial Performance: Strong sales performance, particularly in the US, contributing to significant revenue growth.
• Partnership Benefits: The partnership with Takeda has been crucial for global commercialization.
• Financial Stability: Despite revenue fluctuations, HUTCHMED maintains a strong cash balance and reduced R&D expenses.
• Market Impact: Limited budget impact from the US payer perspective, with potential for prolonged PFS and OS.
• Future Growth: Diverse pipeline and potential NDA filings offer future growth opportunities.

FAQs

Q: What are the key regulatory approvals for fruquintinib?

A: Fruquintinib has been approved in the US, EU, Switzerland, Canada, Japan, the UK, Argentina, Australia, and Singapore as of 2024[1].

Q: How has the partnership with Takeda impacted fruquintinib's commercialization?

A: The partnership has led to the achievement of a $200 million sales milestone and triggered a $20 million commercial milestone payment to HUTCHMED[1].

Q: What is the current financial status of HUTCHMED?

A: HUTCHMED reported a net income of $25.8 million and a cash balance of $802.5 million as of June 30, 2024[2].

Q: How does fruquintinib impact the budget from a US payer perspective?

A: The introduction of fruquintinib has a limited budget impact, estimated to be well below the proposed threshold from ICER, with a per member cost of $0.07 per month and $0.82 per year[4].

Q: What are the future growth prospects for HUTCHMED's pipeline?

A: HUTCHMED's diverse pipeline, including ongoing trials in endometrial and renal cell carcinoma, and potential NDA filings, offer significant future growth opportunities[2][3].

Sources

1. HUTCHMED to Receive First Commercial Milestone Payment Following Fruquintinib Sales by Takeda. HUTCHMED.
2. HUTCHMED Reports 2024 Interim Results and Provides Business Updates. Stock Titan.
3. HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer. Stock Titan.
4. Budget impact analysis of introducing fruquintinib for the treatment of metastatic colorectal cancer. ISPOR.
5. HUTCHMED Reports 2023 Full Year Results and Provides Business Updates. HUTCHMED.

Last updated: 2024-12-16