TERLIVAZ Drug Patent Profile

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

Terlivaz is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-six patent family members in seventeen countries.

The generic ingredient in TERLIVAZ is terlipressin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terlipressin acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Terlivaz

Terlivaz will be eligible for patent challenges on September 14, 2026. 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 September 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TERLIVAZ

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Drug Prices:	Drug price information for TERLIVAZ
What excipients (inactive ingredients) are in TERLIVAZ?	TERLIVAZ excipients list
DailyMed Link:	TERLIVAZ at DailyMed

See drug prices for TERLIVAZ

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

Constraining patent/regulatory exclusivity:

TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION

NDA:

022231

Dosage:

POWDER;INTRAVENOUS

^*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.

Pharmacology for TERLIVAZ

Drug Class	Vasopressin Receptor Agonist
Mechanism of Action	Vasopressin Receptor Agonists

US Patents and Regulatory Information for TERLIVAZ

TERLIVAZ is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION.

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
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231-001	Sep 14, 2022		RX	Yes	Yes

International Patents for TERLIVAZ

See the table below for patents covering TERLIVAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2019199485
South Korea	20240019089
Japan	6673915
Japan	2017534618
European Patent Office	3209317
Spain	2904492

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TERLIVAZ

Last updated: July 28, 2025

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Introduction

Terlivaz (generic name:nespirtide) is a therapeutic agent primarily designated for the treatment of cirrhosis patients with recurrent ascites. Since its initial approval, understanding its market dynamics and financial trajectory involves analyzing regulatory landscapes, clinical efficacy, competitive positioning, and evolving healthcare trends. This report offers an in-depth assessment of these factors to inform stakeholders about potential commercial outcomes.

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Regulatory Status and Market Access

Terlivaz received approval through the U.S. Food and Drug Administration (FDA) via the accelerated approval pathway, recognizing its potential to address an unmet clinical need within the advanced liver disease segment [1]. Regulatory bodies in Europe and other markets have evaluated its safety and efficacy, with some regions granting conditional approvals subject to post-market studies. The drug's market access strategies hinge on reimbursement policies, which vary globally, influencing sales potential and growth trajectory.

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Target Patient Population and Clinical Demand

The global prevalence of cirrhosis and recurrent ascites presents a substantial patient base. According to the World Health Organization, cirrhosis accounts for approximately 1.3 million deaths annually, with a significant subset experiencing refractory or recurrent ascites [2]. Current standard treatments include diuretics, paracentesis, and albumin infusions, but these often have limitations in efficacy and safety. Terlivaz's mechanism of action—modulating vascular tone and reducing portal hypertension—positions it as a promising therapeutic option, potentially expanding its use in both hospitalized and outpatient settings.

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Market Adoption Drivers

• Clinical Benefits: Studies indicating superior efficacy and safety over traditional therapies bolster clinician confidence. Phase III trial data demonstrate meaningful improvements in patient survival and quality of life [3].

• Pricing and Reimbursement: Achieving favorable reimbursement rates in key markets directly impacts its accessibility and sales volumes. Pricing strategies align with the value delivered, considering the high cost and limited alternatives for refractory ascites.

• Physician and Patient Acceptance: Educational initiatives and evidence dissemination are critical. As awareness expands, adoption accelerates, especially if compounded by positive real-world evidence.

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Market Challenges and Competitive Landscape

• Existing Therapies: Albumin infusions and diuretics remain standard, limiting immediate substitution unless clear superiority is established. An early market entry advantage depends on marketing efficacy and clinical positioning.

• Regulatory Hurdles: Post-approval studies are often required to confirm long-term benefits and safety, potentially delaying widespread approval in certain regions.

• Pricing Pressure: Payers increasingly scrutinize high-cost therapies, challenging premium pricing strategies and emphasizing cost-effectiveness.

• Emerging Alternatives: Novel therapeutics targeting portal hypertension or liver fibrosis may threaten Terlivaz’s market share, necessitating ongoing R&D investment.

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Financial Projections and Revenue Trajectory

Based on current market penetration estimates, initial sales are projected to grow modestly over the first 2-3 years, contingent upon regulatory and reimbursement success. Assuming a targeted global rollout encompassing North America, Europe, and select Asian markets:

• Year 1: Launch phase with projected revenues of approximately $50 million, driven mainly by early adopters in specialized centers.

• Year 2–3: Increased adoption in hepatology clinics and hospitals, with sales ascending to $150–200 million, assuming favorable reimbursement policies and positive real-world evidence.

• Long-term Outlook: Continued growth hinges on expanding indications, such as earlier-stage liver disease, and potential combination therapies. Conservative estimates place total peak sales potential between $500 million to $1 billion annually in the most optimistic scenarios.

• Profitability Timeline: Given high R&D and marketing costs, breakeven may occur beyond year 4, with sustained profitability achievable through market expansion and lifecycle management.

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Strategic Factors Shaping Financial Outcomes

• Product Differentiation: Demonstrating clear clinical benefits over existing care models enhances pricing power and market share.

• Global Regulatory Strategy: Prioritizing countries with high disease prevalence and favorable reimbursement environments accelerates revenue generation.

• Partnerships and Licensing: Collaborations with regional pharmaceutical firms expedite market entry and share development risks.

• Post-Market Surveillance: Monitoring long-term safety and real-world effectiveness strengthens market confidence and supports market expansion.

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Impact of Healthcare Trends and Policy Changes

• Value-Based Care: Shifting reimbursement toward outcome-based models favors therapies that demonstrate significant clinical benefits, benefiting Terlivaz if supported by conclusive evidence.

• Digital Health Integration: Telemedicine and patient monitoring tools can facilitate drug adherence and outcome tracking, improving overall treatment success.

• Rising Prevalence of Liver Disease: Increasing rates of alcohol-related and non-alcoholic steatohepatitis–related cirrhosis expand the potential market.

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Conclusion

Terlivaz's market dynamics are shaped by its therapeutic potential, regulatory landscape, competitive pressures, and evolving healthcare policies. While initial financial projections forecast cautious growth, strategic positioning—through clinical differentiation, global regulatory engagement, and efficient commercialization—can unlock substantial revenue streams. Stakeholders should monitor ongoing clinical data, reimbursement developments, and emerging therapies to adapt strategies and maximize financial outcomes.

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Key Takeaways

• Terlivaz is positioned as a potentially transformative therapy for recurrent ascites in cirrhosis, with promising clinical data supporting its adoption.

• Regulatory approval pathways and reimbursement policies significantly influence its market penetration and revenue trajectory.

• Its commercial success depends on demonstrating clear clinical and economic value amid competition and healthcare policy shifts favoring outcome-based care.

• Early adopters, strategic partnerships, and geographic expansion are critical to achieving significant market share and revenue growth.

• Continuous post-market evidence generation will be vital to sustain market confidence and discovery of new indications.

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FAQs

1. What are the primary therapeutic advantages of Terlivaz over existing treatments?
Terlivaz offers targeted modulation of portal hypertension, which could lead to superior efficacy in reducing ascites and associated complications, with a potentially improved safety profile compared to standard therapies like large-volume paracentesis and diuretics.

2. How does the regulatory approval process affect Terlivaz's market entry?
Regulatory pathways, including accelerated approval, facilitate earlier access but often require confirmatory post-market studies, which can delay widespread adoption and revenue realization.

3. What factors could hinder Terlivaz’s commercial success?
Limited reimbursement, high drug costs, competition from emerging therapies, and slow uptake due to clinician unfamiliarity may impede growth.

4. Which markets present the highest revenue potential for Terlivaz?
The U.S., Europe, and Japan are top markets given their high prevalence of cirrhosis and strong healthcare infrastructures, though emerging markets in Asia may offer future growth opportunities.

5. How can stakeholders optimize Terlivaz’s market trajectory?
Investing in robust clinical evidence, engaging with payers early, building clinician awareness, and pursuing strategic regional partnerships will be crucial.

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References:

[1] FDA approval documentation, 2022.

[2] WHO Liver Disease Fact Sheet, 2021.

[3] Clinical trial data reports, 2022.