Telotristat etiprate - Generic Drug Details

What are the generic sources for telotristat etiprate and what is the scope of freedom to operate?

Telotristat etiprate is the generic ingredient in one branded drug marketed by Tersera and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telotristat etiprate has seventy patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for telotristat etiprate

International Patents:	70
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	15
DailyMed Link:	telotristat etiprate at DailyMed

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

Dosage:

TABLET;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 telotristat etiprate

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

Sponsor	Phase
Barbara Ann Karmanos Cancer Institute	Phase 2
National Cancer Institute (NCI)	Phase 2
Ipsen	Phase 1

See all telotristat etiprate clinical trials

Pharmacology for telotristat etiprate

Drug Class	Tryptophan Hydroxylase Inhibitor
Mechanism of Action	Tryptophan Hydroxylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for telotristat etiprate

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for telotristat etiprate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes

International Patents for telotristat etiprate

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	018150
Taiwan	I439457
Ecuador	SP099413
Spain	2562775

Supplementary Protection Certificates for telotristat etiprate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091940	C 2018 007	Romania		PRODUCT NAME: TELOTRISTAT SAU UN ESTER ACCEPTABIL FARMACEUTIC, SAU O SARE A ACESTUIA, IN PARTICULAR ETIL TELOTRISTAT, MAI PARTICULAR SARE HIPURAT DE ETIL TELOTRISTAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1224; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1224; DATE OF FIRST AUTHORISATION IN EEA: 20170918
2091940	713	Finland
2091940	132018000000181	Italy		PRODUCT NAME: TELOTRISTAT O UN SUO ESTERE FARMACEUTICAMENTE ACCETTABILE, O UN SUO SALE, IN PARTICOLARE TELOTRISTAT ETILE, PIU IN PARTICOLARE SALE IPPURATO DI TELOTRISAT ETILE(XERMELO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1224, 20170920
2091940	18C1009	France		PRODUCT NAME: TELOTRISTAT OU L'UN DE SES ESTERS PHARMACEUTIQUEMENT ACCEPTABLES, OU L'UN DE LEURS SELS, EN PARTICULIER LE TELOTRISTAT D'ETHYLE ET PLUS PARTICULIEREMENT L'HIPPURATE DE TELOTRISTAT D'ETHYLE; REGISTRATION NO/DATE: EU/1/17/1224 20170920

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Telotristat Etiprate

Last updated: July 29, 2025

---

Introduction

Telotristat etiprate, an investigational drug primarily targeting carcinoid syndrome-related diarrhea, has garnered significant attention within the pharmaceutical landscape. As an oral serotonin synthesis inhibitor, telotristat etiprate offers a novel approach in managing symptoms associated with neuroendocrine tumors (NETs). Understanding its market dynamics and financial trajectory involves examining clinical progress, regulatory landscape, competitive positioning, and shifting healthcare priorities. This analysis delineates key factors shaping its market potential and investment appeal.

---

Overview of Telotristat Etiprate

Developed by Lexicon Pharmaceuticals and licensed to other collaborators, telotristat etiprate functions as a selective tryptophan hydroxylase (TPH) inhibitor, reducing serotonin production. Its primary indication involves managing carcinoid syndrome diarrhea, a debilitating complication for patients with metastatic neuroendocrine tumors. The drug received FDA approval in 2017 as Xermelo (brand name for telotristat etiprate) for this indication, underscoring its clinical efficacy. It is marketed as an adjunct to somatostatin analogs in controlling refractory diarrhea, with ongoing investigations exploring additional therapeutic scopes.

---

Market Dynamics

1. Clinical Adoption and Therapeutic Need

Carcinoid syndrome affects approximately 10-50% of patients with neuroendocrine tumors, with diarrhea being among the most distressing symptoms. Traditional treatments, including somatostatin analogs, exhibit limitations, especially in refractory cases, creating a compelling clinical unmet need. Telotristat etiprate's mechanism offers targeted serotonin suppression, which directly addresses the pathophysiological basis of diarrhea in these patients.

The adoption rate hinges on clinical guidelines endorsing its use, physician familiarity, and insurance coverage policies. The drug’s real-world uptake remains robust, bolstered by positive Phase III trial results demonstrating significant reductions in bowel movement frequency and symptom burden.

2. Competitive Landscape

While telotristat etiprate carved a niche as the first approved serotonin synthesis inhibitor for carcinoid syndrome, competition persists:

• Somatostatin Analogs (e.g., Octreotide, Lanreotide): Standard-of-care treatments with broad tumor-suppressive and symptom-control properties.
• Emerging Treatments and Pipeline Drugs: Several pipeline agents and combinations aim to improve efficacy and safety profiles. The lack of direct rival drugs targeting serotonin biosynthesis limits immediate competition but does not preclude future entrants.
• New Therapeutic Paradigms: Advances in peptide receptor radionuclide therapy (PRRT) and immunotherapies could influence disease management complexity, indirectly affecting telotristat etiprate’s market share.

3. Regulatory and Reimbursement Environment

Securing regulatory approval was pivotal, and ongoing post-marketing studies are vital for expanding indications. Reimbursement decisions remain a critical driver; positive escalation in insurance coverage and inclusion in clinical guidelines bolster market penetration, especially as healthcare systems prioritize treatments that improve quality of life with demonstrable cost-effectiveness.

4. Geographic Expansion

While FDA approval established a footing in the US, international markets—particularly Europe, Japan, and emerging economies—offer expansive growth opportunities. Regulatory timelines and the ability to demonstrate cost-effectiveness influence timing and magnitude of expansion.

---

Financial Trajectory

1. Revenue Generation and Market Penetration

Since launch, telotristat etiprate (Xermelo) has demonstrated steady growth in sales, driven by increasing diagnosis rates and clinical acceptance. Based on IQVIA data and company disclosures, global sales have grown at a compound annual growth rate (CAGR) consistent with market expansion, although revenue figures remain moderate due to niche indications.

2. Key Revenue Drivers

• Patient Population Expansion: As awareness increases, more patients with refractory carcinoid syndrome receive therapy.
• Combination Therapy Adoption: Integration with somatostatin analogs expands use cases.
• Generics and Biosimilars: Patent expirations, if any, could influence pricing power and margins; currently, patent protections extend into the late 2020s, providing revenue stability.

3. Cost Dynamics and Investment

R&D expenditure for further indications, pharmacovigilance, and global registration processes represent significant investments. Marketing and educational initiatives also sustain sales growth. Operating margins likely reflect a high-cost, specialized treatment model but benefit from premium pricing driven by clinical efficacy and rarity.

4. Future Revenue Projections

Forecasts suggest potential revenue reaching $200 million to $500 million annually within the next 5 years, contingent on successful international launches, broader indication approvals (e.g., other neuroendocrine or serotonin-mediated disorders), and increased physician adoption.

---

Market Challenges and Opportunities

Challenges

• Limited Indication Spectrum: The narrow current use confines revenue; failure to expand indications or address unmet needs limits growth.
• Pricing Pressures: Payer negotiation and healthcare cost containment strategies threaten premium pricing.
• Competitive Advances: Future drugs with superior efficacy or safety could erode market share.

Opportunities

• Pipeline Expansion: Clinical trials investigating telotristat etiprate for other serotonin-mediated conditions (e.g., irritable bowel syndrome, fibromyalgia) could diversify revenue streams.
• Biomarker Development: Precision medicine approaches may identify responders, enhancing treatment efficacy and reimbursement prospects.
• Global Market Penetration: Tailored strategies in emerging markets with high unmet needs can accelerate growth.

---

Conclusion

Telotristat etiprate’s market dynamics hinge on its clinical niche, regulatory approvals, and evolving therapeutic landscape for carcinoid syndrome. Financially, it presents a measured growth trajectory driven by increasing patient awareness, expanding indications, and geographic expansion. While facing challenges such as narrow scope and competitive pressures, the drug's innovative mechanism provides avenues for sustained growth, especially if future indications materialize and global adoption accelerates.

---

Key Takeaways

• Strategic Positioning: Telotristat etiprate holds a unique position as a serotonin synthesis inhibitor, filling an unmet clinical niche.
• Growth Prospects: Market growth depends on international expansion, pipeline success, and potential new indications.
• Financial Outlook: Projected revenues indicate moderate but steady growth, aligned with its niche status but with potential for acceleration.
• Competitive Edge: Its mechanistic novelty and clinical validation provide a durable competitive advantage, though ongoing innovation remains critical.
• Risk Factors: Market expansion may be impeded by pricing pressures, limited indications, or competitive advances.

---

FAQs

1. What is the primary indication for telotristat etiprate?
Telotristat etiprate is approved for managing refractory diarrhea associated with carcinoid syndrome in patients with neuroendocrine tumors, by reducing serotonin production.

2. How does telotristat etiprate differentiate from existing therapies?
It offers a targeted approach by inhibiting TPH, the enzyme responsible for serotonin synthesis, directly addressing the neurotransmitter’s overproduction—a mechanism distinct from somatostatin analogs.

3. What factors could influence the future sales of telotristat etiprate?
Factors include regulatory approvals for additional indications, international market expansion, reimbursement policies, competitive therapies, and emerging research.

4. Are there ongoing clinical trials for telotristat etiprate beyond its current use?
Yes, several trials are exploring its efficacy in other serotonin-mediated disorders, which could broaden its therapeutic applications.

5. How does the competitive landscape impact telotristat etiprate’s market prospects?
While currently holding a first-mover advantage, future entrants or emerging treatments could challenge its market share. Continuous innovation and indication expansion are essential for maintaining its competitive edge.

---

References

[1] FDA approves telotristat etiprate for carcinoid syndrome diarrhea, 2017.
[2] IQVIA sales data for telotristat etiprate, 2022-2023.
[3] Clinical trial data on telotristat etiprate efficacy and safety profiles, published research.
[4] Market analysis reports on neuroendocrine tumors and carcinoid syndrome therapeutics.