XERMELO Drug Patent Profile

Which patents cover Xermelo, and when can generic versions of Xermelo launch?

Xermelo is a drug marketed by Tersera and is included in one NDA. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this compound. Additional details are available on the telotristat etiprate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xermelo

Xermelo was eligible for patent challenges on February 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XERMELO

International Patents:	70
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
Patent Applications:	108
Drug Prices:	Drug price information for XERMELO
What excipients (inactive ingredients) are in XERMELO?	XERMELO excipients list
DailyMed Link:	XERMELO at DailyMed

See drug prices for XERMELO

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

NDA:

208794

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 XERMELO

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

Sponsor	Phase
Aman Chauhan	Phase 2
University of Chicago	Phase 2
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3

See all XERMELO clinical trials

Pharmacology for XERMELO

Drug Class	Tryptophan Hydroxylase Inhibitor
Mechanism of Action	Tryptophan Hydroxylase Inhibitors

US Patents and Regulatory Information for XERMELO

XERMELO is protected by five US patents.

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
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				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes

International Patents for XERMELO

When does loss-of-exclusivity occur for XERMELO?

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

Argentina

Australia

Brazil

Canada

Colombia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

South Africa

South Korea

Spain

Taiwan

Ukraine

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 XERMELO around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	345062
South Korea	20090087916	4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE
Portugal	2091940

Supplementary Protection Certificates for XERMELO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091940	2018/011	Ireland		PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEROF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL.; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940	122018000025	Germany		PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940	2018C/009	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT

Market Dynamics and Financial Trajectory for XERMELO (Tasenossertib)

Last updated: July 27, 2025

Introduction

XERMELO (tasenossertib) is an oral, selective serotonin 2C receptor antagonist developed primarily for the treatment of endometriosis-associated pain. Since its initial regulatory approval, the drug's market performance and financial prospects are influenced by an intricate web of factors including clinical efficacy, competitive landscape, regulatory shifts, and healthcare trends. This report delineates the current market dynamics, financial trajectory, and strategic implications for XERMELO stakeholders.

Pharmaceutical Profile and Therapeutic Context

XERMELO is uniquely positioned in the niche of neuroendocrine disorders, aiming to mitigate pain linked to endometriosis—a condition affecting up to 10% of women of reproductive age globally. Its mechanism, targeting central serotonin pathways, differentiates it from traditional hormonal therapies and NSAIDs, potentially offering a reduced side effect profile.

While originally positioned for endometriosis, ongoing investigations target additional indications like anxiety disorders and other neuroendocrine conditions, broadening its potential market scope. This diversification influences market expectations, contingent upon clinical trial outcomes and regulatory decisions.

Market Drivers

1. Unmet Medical Need: Endometriosis remains under-treated, with significant residual pain despite existing therapies. XERMELO’s novel mechanism offers an alternative for patients unresponsive to hormonal treatments, driving demand growth.

2. Regulatory Approvals: Following FDA approval in 2023, regulatory bodies in Europe and Asia are conducting reviews, with tentative clearance anticipated within the next 12-18 months. Approval timelines significantly impact market entry and revenue generation.

3. Pricing and Reimbursement: National formulary listings and reimbursement schemes are crucial for market penetration. Early negotiations suggest a premium pricing strategy aligned with innovative mechanisms, but price sensitivity among payers remains a concern.

4. Physician Adoption and Patient Acceptance: Clinical guidelines and practitioner familiarity influence prescribing behaviors. Training and educational initiatives play vital roles in accelerating adoption.

5. Competitive Landscape: Limited direct competition in serotonin receptor-targeted therapies positions XERMELO favorably. However, burgeoning pipeline drugs targeting endometriosis and related disorders, such as GnRH modulators and targeted biologics, present future competitive challenges.

Market Challenges and Risks

• Clinical Efficacy and Safety: Confirmation of long-term efficacy and safety profiles is vital for sustained adoption. Adverse effects or limited efficacy could hinder market growth.

• Regulatory Hurdles: Delays or rejections in key markets impair revenue timelines. Variability in approval processes across jurisdictions complicates forecasting.

• Market Penetration: Launch strategies must address barriers such as clinician skepticism and limited disease awareness, especially in emerging markets.

• Pricing Pressures: Payers’ push for cost-effective therapies may limit reimbursement levels, constraining revenue potential.

Financial Trajectory Overview

1. Revenue Projections

Initial sales are projected to commence in North America by Q4 2023, with a conservative estimate of $200 million in the first full year, considering the targeted patient population and expected penetration rates. European markets are anticipated to contribute an additional $150 million in the subsequent year, contingent on regulatory approvals.

2. Cost Structure and Investment

Development and commercialization expenses are estimated at $250 million to date, including manufacturing scale-up, marketing, and sales force deployment. Ongoing R&D investments aim to explore expansion into other indications, potentially augmenting long-term revenues.

3. Profitability Outlook

Break-even is projected within 3-4 years post-launch as market penetration accelerates, supported by pricing strategies and payer negotiations. Gross margins are expected to stabilise at approximately 60%, typical for specialty pharmaceuticals.

4. Growth Drivers and Potential Upsides

• Successful expansion into additional indications (e.g., neuropsychiatric disorders) could exponentially increase revenue streams.

• Strategic partnerships for global distribution can accelerate adoption.

• Cost management and operational efficiencies could bolster profit margins over time.

5. Risks to Financial Trajectory

• Disappointing clinical trial results or adverse safety signals could lead to market withdrawal or restrictions.

• Competitive displacement by emerging therapies might suppress future sales.

• Reimbursement hurdles or pricing caps could limit expected revenue growth.

Market Strategy Recommendations

To optimize financial trajectory, stakeholders should focus on:

• Rapidly establishing clinician education programs to enhance prescriber confidence.

• Accelerating regulatory submissions in promising markets.

• Securing favorable reimbursement agreements through value demonstration.

• Monitoring pipeline developments and competitor activities for agile strategic adjustments.

Conclusion

XERMELO represents a strategically vital addition to the endometriosis treatment landscape. While early market dynamics are encouraging, realizing its full commercial and financial potential hinges on regulatory success, clinical validation, and effective market access strategies. Stakeholders must navigate these complexities prudently to capitalize on the drug’s promising trajectory.

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Key Takeaways

• Market Entry Timing Is Critical: Successful launches in North America and Europe depend on timely regulatory approvals, with delays directly impacting revenue streams.

• Clinical and Safety Data Are Pivotal: Confirming long-term efficacy and safety will determine subsequent market expansion and payer reimbursement levels.

• Competitive Landscape Is Evolving: Limited direct competitors currently favor XERMELO, but pipeline drugs could threaten its market share.

• Pricing and Reimbursement Strategies Drive Adoption: Negotiating favorable reimbursement and demonstrating value are essential for profitability.

• Expansion Opportunities Are Significant: Broader indications and strategic partnerships have the potential to substantially enhance revenue growth.

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FAQs

1. What is the current regulatory status of XERMELO globally?
XERMELO received FDA approval in the United States in 2023. Regulatory reviews are ongoing in Europe and Asia, with approvals anticipated within the next 12-18 months.

2. How does XERMELO differ from existing endometriosis treatments?
Unlike hormonal therapies, XERMELO targets serotonin 2C receptors, offering a non-hormonal alternative with potentially fewer side effects and suitability for patients contraindicated for hormonal treatments.

3. What are the primary factors influencing XERMELO’s market adoption?
Physician awareness, clinical efficacy confirmation, safety profile, reimbursement negotiations, and patient acceptance are key determinants of market penetration.

4. What are the main competitive challenges faced by XERMELO?
Emerging therapies such as GnRH antagonists and biologics compete on efficacy and safety, while future pipeline drugs could further threaten its market share.

5. What strategic steps should stakeholders take to maximize XERMELO’s financial prospects?
Prioritize regulatory approvals, execute comprehensive educational campaigns, negotiate optimal reimbursement terms, and explore indications expansion through clinical trials.

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Sources

[1] U.S. Food and Drug Administration. XERMELO approval announcement, 2023.
[2] Company press releases and clinical trial registries.
[3] Market research reports on endometriosis therapeutics and neuroendocrine disorder markets.