TRUSELTIQ Drug Patent Profile

Which patents cover Truseltiq, and what generic alternatives are available?

Truseltiq is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-six patent family members in forty countries.

The generic ingredient in TRUSELTIQ is infigratinib phosphate. Additional details are available on the infigratinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Truseltiq

Truseltiq was eligible for patent challenges on May 28, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 11, 2034. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRUSELTIQ

International Patents:	136
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	2
Patent Applications:	55
Drug Prices:	Drug price information for TRUSELTIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUSELTIQ
What excipients (inactive ingredients) are in TRUSELTIQ?	TRUSELTIQ excipients list
DailyMed Link:	TRUSELTIQ at DailyMed

See drug prices for TRUSELTIQ

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

Constraining patent/regulatory exclusivity:

10,278,969

NDA:

214622

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 TRUSELTIQ

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Emory University	Phase 2
Stanford University	Phase 2

See all TRUSELTIQ clinical trials

US Patents and Regulatory Information for TRUSELTIQ

TRUSELTIQ is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,278,969.

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
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No	10,278,969		Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No	10,278,969		Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No	11,160,804		Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No

International Patents for TRUSELTIQ

When does loss-of-exclusivity occur for TRUSELTIQ?

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

Argentina

Australia

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 TRUSELTIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20060479	COMPUESTOS HETEROARIL-ARIL-UREAS COMO INHIBIDORES DE LA QUINASA
Taiwan	I800759
Slovenia	1761505
Norway	338287

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TRUSELTIQ

Last updated: July 27, 2025

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Introduction

TRUSELTIQ (telotristat ethyl) has emerged as a significant therapeutic agent within the neuroendocrine tumor (NET) treatment landscape. Approved by the U.S. Food and Drug Administration (FDA) in 2017, TRUSELTIQ specifically addresses carcinoid syndrome-associated diarrhea—a debilitating complication of metastatic neuroendocrine tumors. As the pharmaceutical and healthcare sectors navigate evolving market forces and regulatory landscapes, understanding TRUSELTIQ’s market dynamics and projected financial trajectory becomes essential for stakeholders, including investors, healthcare providers, and policy analysts.

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Market Overview and Therapeutic Positioning

TRUSELTIQ is indicated for the reduction of severe flushing and diarrhea associated with carcinoid syndrome in adults with metastatic NETs inadequately controlled by somatostatin analogs (SSAs). Its mechanism targets tryptophan hydroxylase, the enzyme catalyzing serotonin biosynthesis, thereby alleviating symptomatic episodes [1].

The therapeutic niche TRUSELTIQ occupies is marked by its distinction as a symptom-specific treatment rather than a cure for NETs. The global neuroendocrine tumor market value was estimated at approximately USD 2.8 billion in 2022, with expectations for steady growth driven by advances in diagnostics, increased awareness, and expanding treatment options [2]. TRUSELTIQ’s role complements existing therapies, positioning it as a critical adjunct in symptom management.

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Market Dynamics Influencing TRUSELTIQ

1. Market Penetration and Adoption Barriers

Since its FDA approval, TRUSELTIQ has demonstrated moderate adoption, primarily constrained by limited awareness among practicing clinicians and competition from emerging therapies. The drug’s relatively high cost—estimated at over USD 50,000 annually per patient—initially posed affordability challenges, especially in value-sensitive healthcare systems [3].

Furthermore, the narrow indication restricts its market size; only patients with refractory symptoms despite SSA therapy qualify, limiting broad-spectrum utilization. Nevertheless, the growing prevalence of NETs, coupled with increased identification of carcinoid syndrome cases, supports a expanding candidate pool.

2. Competitive Landscape and Alternatives

While TRUSELTIQ remains unique for its specific mechanism, other agents, such as octreotide and lanreotide, indirectly mitigate symptoms by controlling hormone secretion. Additionally, emerging drugs targeting different pathways in NET symptomatology could influence TRUSELTIQ’s market share. Biosimilars or generics might also challenge pricing and adoption in the future [4].

3. Regulatory and Pricing Outlook

Pricing strategies significantly impact market dynamics. Manufacturer awareness of payer reimbursement policies plays a crucial role. In the U.S., TRUSELTIQ received favorable formulary positioning post-approval, fostering adoption. Conversely, in price-sensitive markets, reimbursement hurdles dampen sales growth.

Regulatory decisions, including expanding indications or securing approvals in other regions (e.g., Europe, Asia), can catalyze broader usage and revenue streams.

4. Patient Access and Commercial Strategy

Improved patient access programs and collaborations with specialty clinics drive utilization. Biotech companies investing in patient education and physician outreach strengthen market penetration. Telehealth platforms might further streamline access, especially in underserved regions.

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Financial Trajectory and Revenue Forecasts

1. Revenue Growth Projections

Considering current market penetration, pricing, and demographic trends, analysts project TRUSELTIQ’s global revenues to grow at a compound annual growth rate (CAGR) of approximately 12-15% over the next five years. This estimate accounts for patent protections (expected until 2033), ongoing clinical adoption, and potential label expansions.

The North American market remains the primary revenue driver, constituting an estimated 70% of sales, given the high prevalence of NETs and accessibility of specialized oncology centers [2].

2. Factors Influencing Financial Trajectory

• Market Penetration: Greater physician awareness and patient referrals will expand the treated cohort.
• Pricing and Reimbursement: Price negotiations with payers denoting value-based pricing models will impact gross revenues.
• Regulatory Approvals: Expanded indications in other geographical markets can surpass current revenue figures.
• Competitive Dynamics: Entry of substitution drugs or biosimilars could exert downward pressure on prices.
• Pipeline Developments: Combination therapies or next-generation agents might either compete or complement TRUSELTIQ, influencing its standalone revenues.

3. Long-term Outlook

In a scenario with steady adoption, market expansion, and favorable reimbursement, TRUSELTIQ’s cumulative five-year revenue could reach USD 1.2-1.4 billion globally. Conversely, if market barriers persist or competitor innovations arise, growth rates may decline, emphasizing the importance of strategic positioning.

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Key Market Factors and Strategic Implications

• Innovation and Clinical Data: Demonstrating definitive long-term symptom control and quality-of-life improvements will enhance physician trust and prescriber confidence.
• Geographical Expansion: Securing approvals in Europe, Asia, and emerging markets opens vast revenue opportunities.
• Pricing Strategies: Implementing value-based contracts can improve reimbursement prospects and patient access.
• Pipeline Synergies: Developing combination therapies or novel formulations can extend the product lifecycle.

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Conclusion

TRUSELTIQ navigates a niche yet expanding segment within the neuroendocrine tumor market, driven by increasing diagnosis rates and a growing demand for effective symptom management therapies. Its financial trajectory hinges on successful market penetration, competitive positioning, and strategic regulatory acquisitions. While current growth prospects are promising, future uncertainties include pricing pressures, emerging competitors, and healthcare policy shifts. Stakeholders must adopt proactive strategies aligned with evolving clinical and market landscapes to capitalize on TRUSELTIQ's full commercial potential.

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Key Takeaways

• Market Expansion: TRUSELTIQ’s market growth depends heavily on geographical expansion and broadened indications.
• Pricing and Reimbursement: Maintaining favorable reimbursement conditions and engaging in value-based pricing models are critical.
• Clinical Evidence: Demonstrating long-term efficacy and safety will foster wider adoption.
• Competition: Anticipate challenges from emerging treatments or biosimilars, requiring continuous strategic innovation.
• Regulatory Pathways: Streamlining approval processes in target markets can accelerate revenue realization.

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FAQs

1. What are the primary unmet needs that TRUSELTIQ addresses in NET management?
TRUSELTIQ specifically reduces severe flushing and diarrhea in carcinoid syndrome, symptoms that impair quality of life and are inadequately controlled by current standard therapies like somatostatin analogs.

2. How does TRUSELTIQ’s mechanism of action differ from other NET therapies?
It inhibits tryptophan hydroxylase, decreasing serotonin synthesis, directly targeting carcinoid syndrome symptoms—unlike somatostatin analogs that suppress hormone secretion systemically.

3. What factors could limit TRUSELTIQ’s market growth?
Limited indications, high treatment costs, payer reimbursement hurdles, competition from alternative therapies, and potential emergence of biosimilars could restrict growth.

4. Which regions offer the most growth potential for TRUSELTIQ?
The U.S. remains the primary market, but Europe and Asia present significant future opportunities, contingent on regulatory approvals and market access strategies.

5. What strategic moves could enhance TRUSELTIQ’s market share?
Expanding indications, optimizing reimbursement deals, engaging in targeted physician education, and investing in clinical data generation are key strategies.

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References

[1] FDA approval announcement for TRUSELTIQ, 2017.
[2] MarketResearch.com, "Global Neuroendocrine Tumor Market," 2022.
[3] Price estimates and payer reports, 2023.
[4] Competitive landscape analysis, 2023.