TERLIPRESSIN ACETATE - Generic Drug Details

What are the generic sources for terlipressin acetate and what is the scope of patent protection?

Terlipressin acetate is the generic ingredient in one branded drug marketed by Mallinckrodt Ireland and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Terlipressin acetate has thirty-six patent family members in seventeen countries.

There is one drug master file entry for terlipressin acetate. One supplier is listed for this compound.

Summary for TERLIPRESSIN ACETATE

International Patents:	36
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	4
DailyMed Link:	TERLIPRESSIN ACETATE at DailyMed

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

Constraining patent/regulatory exclusivity:

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

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.

Recent Clinical Trials for TERLIPRESSIN ACETATE

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

Sponsor	Phase
Ain Shams University	Phase 2
Kasr El Aini Hospital	Phase 2
Mallinckrodt	Phase 3

See all TERLIPRESSIN ACETATE clinical trials

Pharmacology for TERLIPRESSIN ACETATE

Drug Class	Vasopressin Receptor Agonist
Mechanism of Action	Vasopressin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for TERLIPRESSIN ACETATE

H01BA	Vasopressin and analogues
H01B	POSTERIOR PITUITARY LOBE HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for TERLIPRESSIN ACETATE

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 TERLIPRESSIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Portugal	3978074
Japan	7346494
Japan	6673915
European Patent Office	4351619
Mexico	2023013686

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Terlipressin Acetate

Last updated: July 27, 2025

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Introduction

Terlipressin acetate, a synthetic vasopressin analog, has garnered attention within the pharmaceutical landscape primarily for its therapeutic efficacy in managing conditions such as bleeding esophageal varices and hepatorenal syndrome. Its unique pharmacology and targeted application have driven specific market dynamics, influencing its financial trajectory globally. This comprehensive analysis outlines the current market environment, key drivers and challenges, pipeline outlook, and financial projections shaping the future of terlipressin acetate.

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Pharmacological Profile and Therapeutic Applications

Terlipressin operates as a selective vasoconstrictor by stimulating vasopressin receptors, mainly V1 receptors, resulting in reduced portal hypertension and improved hemodynamics in acute settings. Its primary approved use is for controlling gastrointestinal bleeding due to portal hypertension, especially in cirrhotic patients—an area with significant unmet clinical needs. Additionally, in regions where approved, it is employed in the management of hepatorenal syndrome, offering a targeted intervention that mitigates renal vasoconstriction [1].

The drug's pharmacokinetics, characterized by a longer half-life compared to vasopressin, allow for easier dosing and improved patient compliance, factors that support its continued clinical adoption.

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Market Landscape and Key Players

Regional Market Presence

• Europe: Countries such as the UK and Germany have historically led in the utilization of terlipressin, owing to regulatory approvals and established clinical protocols. European guidelines recognize its efficacy in gastrointestinal bleeding management.

• North America: The United States remains a significant market due to high burden of cirrhosis-related complications; however, terlipressin's approval status restricts widespread use pending FDA confirmation or approval.

• Asia-Pacific: Rapid increases in hepatitis B prevalence and rising liver cirrhosis cases have propelled regional demand. Local manufacturing and imported formulations contribute to the growth in this high-incidence area.

• Emerging Markets: India and Brazil display increasing adoption, driven by expanding healthcare infrastructure and unmet needs for cost-effective therapies.

Key Market Participants

The global supply of terlipressin acetate involves both generic manufacturers and some branded formulations, with pivotal players including:

• Ferring Pharmaceuticals: The original European manufacturer, holding leading market share due to early approval and established supply chain.

• Hospira (now Pfizer): Provided generics in certain regions, expanding accessibility.

• Local Generic Manufacturers: In emerging markets, regional companies produce cost-effective formulations, stimulating broader adoption.

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Market Drivers

Clinical Efficacy and Safety Profile: The proven effectiveness of terlipressin in controlling variceal bleeding and improving renal function in hepatorenal syndrome supports sustained clinical use. Its targeted mechanism minimizes systemic side effects compared to broader vasopressin analogs.

Unmet Medical Needs: Despite established therapies, there is a continuous demand for more effective, safer, and cost-efficient interventions for portal hypertension complications.

Regulatory Approvals and Off-Label Use: Certain regions have approved terlipressin for specific indications, enhancing market penetration. Off-label applications further expand its use, especially where alternatives are limited.

Rising Prevalence of Liver Diseases: The increasing incidence of cirrhosis worldwide correlates with greater need for interventions like terlipressin, particularly amidst rising hepatitis B and C infections.

Healthcare Infrastructure Improvements: Enhanced access in emerging markets facilitates broader prescribing patterns.

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Market Challenges

Regulatory Hurdles: The absence of FDA approval in the U.S. remains a significant barrier to widespread usage in North America. Regulatory delays or refusals deter investment and market expansion.

Limited Awareness and Education: Variability in clinician familiarity hampers quick adoption, especially outside traditional markets.

Cost and Reimbursement Issues: While cost-effective in many regions, high licensing fees or reimbursement limitations can inhibit its integration into standard care pathways.

Availability and Supply Chain Constraints: Manufacturing complexities and regional distribution barriers can lead to shortages, impacting consistent market growth.

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Pipeline and Developmental Outlook

While terlipressin remains primarily in a mature stage, recent clinical trials and regulatory submissions hint at potential expansion:

• Expanded Indications: Trials exploring terlipressin's utility in other vasoplegic states or shock syndromes could open new markets.

• Formulation Innovations: Developing inhaled or sustained-release formulations to improve administration and patient compliance.

• Combination Therapies: Pairing terlipressin with other agents to enhance efficacy in complex conditions.

However, pipeline activity remains limited, primarily due to the drug's established positioning and manufacturing stability.

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Financial Trajectory and Market Forecasts

Historical Market Performance

The global market for terlipressin was valued approximately at USD 200-300 million in 2021, with Europe dominating demand. Growth rates have hovered around 4-6% annually, driven by rising liver disease prevalence and regional adoption.

Forecasted Growth Trends

• Compound Annual Growth Rate (CAGR): The market is projected to reach USD 400 million by 2028, representing a CAGR of 8-10%, influenced by increasing adoption in emerging markets, regulatory approvals, and inclusion in clinical guidelines.

• Regional Focus: Growth in Asia-Pacific and Latin America is expected to outpace mature markets owing to expanding healthcare infrastructure and rising disease burdens.

• Pricing Dynamics: Generic production and regional manufacturing could exert downward pressure on prices, improving access but compressing profit margins for incumbent players.

• Impact of Regulatory Approvals: FDA clearance in North America could serve as a catalyst, potentially doubling market size, but currently remains uncertain.

Revenue Distribution and Profitability

Profit margins for manufacturers derive from generic sales, with pricing sensitive to competition. Branded formulations command premium pricing but face reimbursement and formulary challenges. Strategic alliances and licensing agreements will influence financial outcomes.

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Strategic Implications for Stakeholders

Pharmaceutical companies should focus on building robust clinical evidence and pursuing regulatory harmonization to facilitate market expansion.
Investors should monitor pipeline developments and regional regulatory decisions.
Healthcare providers must stay informed about evolving guidelines and formulary updates to optimize patient care with effective therapies like terlipressin.

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Key Takeaways

• Expanding Clinical Use: The efficacy of terlipressin in managing variceal bleeding and hepatorenal syndrome sustains its core market but opportunities exist for broader indications.

• Regulatory Landscape: Approval in key markets, especially North America, could dramatically alter its financial trajectory.

• Regional Growth Opportunities: Asia-Pacific and Latin America constitute high-growth regions driven by rising liver disease incidence.

• Pricing and Competition: Generics are likely to dominate, exerting downward pressure on prices, yet brand loyalty and clinical preferences influence market stability.

• Innovation and Pipeline: Limited pipeline activity suggests a focus on optimizing existing formulations; innovation in delivery methods remains a potential differentiator.

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5 Unique FAQs

1. What factors influence the adoption of terlipressin acetate in new markets?
Regulatory approval processes, clinical guideline inclusion, healthcare infrastructure, clinician familiarity, and reimbursement policies significantly impact adoption rates.

2. How does the availability of generics affect the market for terlipressin acetate?
Generics increase market accessibility by reducing costs, expand geographic reach, and intensify competition, potentially impacting profitability for branded manufacturers.

3. Are there significant safety concerns associated with terlipressin?
While generally well-tolerated, adverse effects like ischemia, hypertension, and abdominal cramps can occur, necessitating careful patient selection and monitoring.

4. What opportunities exist for pipeline modernization of terlipressin?
Development of novel formulations, combination therapies, and wider approval for additional indications could expand therapeutic uses and market share.

5. How might emerging regional healthcare policies impact the future of terlipressin?
Policies favoring cost-effective therapies and expanding access to high-demand treatments will likely bolster terlipressin's adoption, especially if regulatory hurdles are addressed.

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References

[1] European Medicines Agency. (2020). Terlipressin summary of product characteristics. EMA.