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FRUZAQLA Drug Patent Profile

When do Fruzaqla patents expire, 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 sixty-eight patent family members in thirty-two 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 November 8, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FRUZAQLA

International Patents:	68
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	72
Drug Prices:	Drug price information for FRUZAQLA
What excipients (inactive ingredients) are in FRUZAQLA?	FRUZAQLA excipients list
DailyMed Link:	FRUZAQLA at DailyMed

See drug prices for FRUZAQLA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217564

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 FRUZAQLA

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

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Takeda Pharms Usa	FRUZAQLA	fruquintinib	CAPSULE;ORAL	217564-002	Nov 8, 2023		RX	Yes	Yes

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

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
Russian Federation	2506261	ПРОИЗВОДНЫЕ ХИНАЗОЛИНА (QUINAZOLINE DERIVATIVES)
Denmark	3191475
Japan	2011519956
Slovenia	2297115

FRUZAQLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FRUZAQLA

Introduction

FRUZAQLA, the brand name for the drug fruquintinib, has emerged as a significant player in the oncology market, particularly in the treatment of metastatic colorectal cancer. Developed by HUTCHMED (China) Ltd., this drug has seen substantial success in both the U.S. and European markets. Here, we delve into the market dynamics and financial trajectory of FRUZAQLA.

Market Approval and Launch

FRUZAQLA received FDA approval in November 2023 for use in the United States, marking a pivotal moment in HUTCHMED's global expansion[2][3][4].

• The drug also gained European approval in June 2024, further expanding its reach into key international markets[2][4].

Sales Performance

Since its launch, FRUZAQLA has demonstrated strong commercial traction:

• In the U.S., the drug generated $130.5 million in sales from its November 2023 launch to the end of June 2024[2][3].
• Global sales, particularly driven by Takeda's commercial efforts, reached over $200 million in the nine months ended September 2024, triggering a $20 million milestone payment to HUTCHMED[4].

Revenue Impact

The success of FRUZAQLA has significantly contributed to HUTCHMED's revenue:

• Oncology product revenue increased by 59% to $127.8 million in the first half of 2024, largely driven by FRUZAQLA's U.S. sales[2].
• Total revenue for HUTCHMED, however, decreased to $305.7 million in the first half of 2024, primarily due to lower milestone payments from Takeda compared to the previous year[2].

Geographical Sales

The drug's sales performance varies by region:

• In the U.S., FRUZAQLA sales have been robust, with $130.5 million generated since its launch[2].
• In China, while the drug has been approved since 2018, sales growth has slowed to 8% in the first half of 2024, compared to a significant 111% growth in 2021[1].

Pricing and Profitability

The pricing of FRUZAQLA highlights the disparity between different markets:

• A pack of 21 capsules containing 5 milligrams of the drug is priced at $25,200 in the U.S., significantly higher than the price in China, which is around 7,541 yuan (approximately $1,000)[1].
• Despite higher prices in international markets, the drug's inclusion in China's state healthcare insurance scheme means lower prices and thinner profits domestically[1].

Partnership with Takeda

The partnership with Takeda Pharmaceutical has been crucial for FRUZAQLA's global success:

• Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau[4].
• The partnership includes significant upfront payments and milestone revenues, such as the $259 million down payment received in 2023 and the recent $20 million milestone payment for exceeding $200 million in sales[1][4].

Financial Outlook

HUTCHMED's financial outlook is influenced by the performance of FRUZAQLA:

• The company is guiding for Oncology/Immunology consolidated revenues of $300-$400 million in 2024, driven by continued growth in FRUZAQLA sales and other oncology products[2][3].
• Despite a reduction in net profits due to the high base effect from last year's licensing deal, HUTCHMED remains financially strong with a cash balance of $802.5 million as of June 30, 2024[2].

Research and Development

HUTCHMED has been focusing on reducing research and development expenses while advancing its pipeline:

• R&D expenses were reduced by 34% to $95.3 million in the first half of 2024, reflecting the company's efforts to optimize costs[2].
• Future plans include potential U.S. NDA filings for other drugs, such as savolitinib, and continued commercial preparations for FRUZAQLA in new markets[2].

Market Potential

The market potential for FRUZAQLA is substantial:

• Colorectal cancer is the second most common cause of cancer-related deaths in the U.S., with approximately 840,000 new cases annually across the U.S., Europe, and Japan[4].
• The drug's approval in multiple jurisdictions, including the EU, Switzerland, Canada, Japan, the UK, Argentina, Australia, and Singapore, further expands its market reach[4].

Challenges and Opportunities

While FRUZAQLA has shown strong commercial performance, there are challenges and opportunities ahead:

• The lumpy nature of milestone payments can create volatility in top-line results, but the company's strong cash position provides a buffer for continued investments in R&D and commercial activities[2].
• The potential for higher milestone revenues and the prospect of further approvals and launches globally could drive sustained revenue growth[3].

Key Takeaways

• Strong Sales Performance: FRUZAQLA has generated significant revenue since its U.S. launch, with $130.5 million in sales in the first half of 2024.
• Global Expansion: The drug has received approvals in multiple international markets, including the EU, and is expected to continue its global rollout.
• Financial Impact: Despite a decrease in total revenue due to lower milestone payments, oncology product revenue has increased by 59%, driven by FRUZAQLA.
• Partnership Success: The partnership with Takeda has been instrumental in FRUZAQLA's global success, with significant milestone payments.
• Future Outlook: HUTCHMED is guiding for $300-$400 million in Oncology/Immunology revenues in 2024, with a strong cash balance to support continued growth.

FAQs

Q: What is FRUZAQLA, and what is it used for? A: FRUZAQLA is the brand name for the drug fruquintinib, used in the treatment of metastatic colorectal cancer.

Q: When did FRUZAQLA receive FDA approval? A: FRUZAQLA received FDA approval in November 2023.

Q: How much revenue has FRUZAQLA generated in the U.S. since its launch? A: FRUZAQLA has generated $130.5 million in U.S. sales since its launch in November 2023.

Q: What is the significance of the partnership between HUTCHMED and Takeda? A: The partnership allows Takeda to exclusively develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau, and has provided significant upfront and milestone payments to HUTCHMED.

Q: What is HUTCHMED's financial outlook for 2024? A: HUTCHMED is guiding for Oncology/Immunology consolidated revenues of $300-$400 million in 2024, driven by continued growth in FRUZAQLA sales and other oncology products.

Cited Sources

1. Benzinga: "Hutchmed scores U.S. success with cancer drug, but profits still dip"[1]
2. Stocktitan: "HUTCHMED Reports 2024 Interim Results and Provides Business Updates"[2]
3. Trinity Delta: "Executing consistently on the road to breakeven"[3]
4. Biospace: "HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA Sales by Takeda"[4]