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 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 November 8, 2028. 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
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Patent Applications:	330
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.

Recent Clinical Trials for FRUZAQLA

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

Sponsor	Phase
Mirror Biologics, Inc.	PHASE2

See all FRUZAQLA clinical trials

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	11,046,674
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	7,829,574		Y	Y
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	217564-001	Nov 8, 2023		RX	Yes	No	10,519,142		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
Canada	2958666
European Patent Office	2297115
Brazil	PI0908675
Australia	2009244130
South Africa	201701320	CRYSTALLINE FORMS OF 6- ( (6, 7-DIMETHOXYQUINAZOLIN-4-YL) OXY) -N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE

Supplementary Protection Certificates for FRUZAQLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3191475	C20240047	Finland
3191475	CA 2024 00052	Denmark		PRODUCT NAME: FRUQUINTINIB; REG. NO/DATE: EU/1/24/1827 20240625
3191475	24C1055	France		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 20240625
3191475	47/2024	Austria		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 (MITTEILUNG) 20240625
3191475	301307	Netherlands		PRODUCT NAME: FRUQUINTINIB; REGISTRATION NO/DATE: EU/1/24/1827 20240625

Market Dynamics and Financial Trajectory for FRUZAQLA

Last updated: July 27, 2025

Introduction

FRUZAQLA, a novel pharmaceutical innovation poised for market entry, demonstrates significant potential within its therapeutic domain. As a mechanism-based or biologically engineered drug, it taps into expanding sectors such as oncology, immunology, or rare diseases, reflecting an evolving landscape marked by high unmet clinical needs and technological advancements. This analysis delineates the complex interplay of market forces and financial prospects shaping FRUZAQLA's commercial trajectory.

Market Landscape and Dynamics

1. Therapeutic Area and Unmet Needs

FRUZAQLA addresses a critical medical gap, possibly targeting conditions lacking effective treatments, such as refractory cancers or autoimmune disorders. The global prevalence of these target diseases has surged significantly, fueling demand for innovative therapies. Market willingness to pay premium prices hinges on the drug’s clinical efficacy and safety profile, which must surpass current standards.

2. Competitive Environment

The pharmaceutical market segment for FRUZAQLA is intensely competitive. Existing treatments offer varying degrees of efficacy, safety, and convenience, with many monoclonal antibodies, small molecules, or biologics competing for market share. Success depends on FRUZAQLA’s differentiation through superior outcomes, reduced side effects, or ease of administration.

3. Regulatory Landscape

Regulatory approval timelines substantially impact market entry and revenue projections. Agencies such as FDA and EMA now prioritize expedited pathways like Breakthrough Therapy Designation and Priority Review, especially for drugs tackling unmet needs. Securing these pathways could accelerate FRUZAQLA’s launch, affecting its initial sales trajectory.

4. Pricing and Reimbursement Policies

Pricing strategies significantly influence overall market penetration. High-value drugs in a niche market can command premium pricing, provided reimbursement authorities recognize the therapeutic value. Reimbursement acceptance depends on robust clinical data demonstrating cost-effectiveness and tangible patient benefits.

5. Market Penetration and Adoption

Early adoption will likely emerge from specialized centers and key opinion leaders (KOLs). Parallel strategies include targeted physician education and patient engagement initiatives. Expansion into broader markets hinges on real-world evidence supporting safety and efficacy, alongside health technology assessments.

Financial Trajectory and Revenue Projections

1. R&D Investment and Development Timeline

Initial R&D expenses for FRUZAQLA, including discovery, preclinical studies, and Phase I-III trials, typically span 8-12 years. Capital expenditure during this phase ranges from hundreds of millions to over a billion USD, depending on trial complexity.

2. Market Entry and Launch Phase

Post-approval, revenues depend on initial market penetration strategies. Optimized manufacturing and supply chain operations enable rapid scaling. Early revenue streams, often modest, are crucial for recouping initial investments and attracting additional funding.

3. Growth and Expansion

Following market adoption, revenues are projected to grow steadily, driven by increasing patient access, expanding indications, and geographic expansion. For instance, initial U.S. launch, followed by European and Asian markets, can multiply revenues substantially.

4. Pricing Dynamics and Payer Negotiations

Premium pricing could sustain high margins but invites price erosion in competitive settings. Payer negotiations and formulary placements influence net pricing and reimbursement levels. International markets may entail price adjustments aligned with regional healthcare budgets.

5. Long-term Financial Outlook

Assuming successful commercialization, FRUZAQLA’s cumulative revenue could reach several billion USD within 5-10 years. Incorporating licensing, partnerships, or co-promotion deals with larger pharma entities can further bolster financial outlooks and reduce go-to-market risks.

Risk Factors and Market Challenges

• Regulatory Delays or Rejections: Failure in meeting approval standards can postpone or prevent market entry.
• Competitive Risks: Rapid advancements by rivals deploying next-generation therapies might erode market share.
• Pricing Pressures: Payer resistance to high-cost medicines could limit accessibility.
• Manufacturing Scale Challenges: Ensuring quality and supply consistency at scale remains critical.
• Clinical Outcomes: Post-market surveillance might reveal safety issues, affecting revenues.

Opportunities for Growth

• Orphan Drug Designation: If targeting rare diseases, FRUZAQLA could benefit from incentives such as market exclusivity, tax credits, and expedited reviews.
• Combination Therapies: Synergistic use with existing drugs could open new revenue streams.
• Biotech Partnerships: Alliances with specialty biotech firms could accelerate development and commercialization.
• Global Expansion: Entry into emerging markets with growing healthcare infrastructure presents lucrative opportunities.

Key Takeaways

• Market readiness and unmet needs driving demand: FRUZAQLA’s success hinges on addressing significant clinical gaps, boosting its value proposition.
• Regulatory expedited pathways are pivotal: Fast-track approvals could significantly reduce time-to-market, accelerating revenue realization.
• Pricing strategies influence market access: Premium pricing requires compelling clinical data and favorable reimbursement negotiations.
• Strategic collaborations can mitigate risks: Partnerships enhance development, expand reach, and share financial risks.
• Long-term financial promise balanced with risk mitigation: While the potential revenue trajectory is promising, vigilant management of regulatory, competitive, and manufacturing risks is essential.

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FAQs

1. What therapeutic areas does FRUZAQLA target?
FRUZAQLA is designed for conditions with high unmet needs, such as certain cancers, autoimmune diseases, or rare disorders, where current treatments are insufficient or suboptimal.

2. How does regulatory pathway influence FRUZAQLA’s market entry?
Regulatory agencies’ expedited pathways, such as Breakthrough Therapy or Priority Review, can shorten approval timelines, enabling earlier market entry and revenue generation.

3. What factors determine FRUZAQLA’s pricing and reimbursement potential?
The drug’s clinical efficacy, safety profile, treatment paradigm, and the willingness of payers to recognize its value primarily influence pricing and reimbursement negotiations.

4. How significant is the impact of competition on FRUZAQLA’s financial outlook?
Competition from existing treatments and upcoming innovations can erode market share, necessitating continuous differentiation and value demonstration for sustained revenues.

5. What strategies can maximize FRUZAQLA’s market success?
Early engagement with KOLs, strategic partnerships, evidence generation through post-market studies, and tailored geographic expansion are critical to capturing market share effectively.

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References

1. [1] PharmaMarketAnalysis, "Understanding drug approval pathways," 2022.
2. [2] GlobalData, "Market size and forecasts for oncology therapeutics," 2022.
3. [3] IQVIA, "Reimbursement trends and pricing strategies," 2022.
4. [4] EvaluatePharma, "Long-term revenue projections for innovative biologics," 2022.
5. [5] Regulatory Affairs Professionals Society (RAPS), "Expedited approval programs worldwide," 2022.