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-five 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:	35
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
Patent Applications:	5,275
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	10,335,452

International Patents for TERLIPRESSIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Canada	3219851	METHODE DE TRAITEMENT DE PATIENTS ATTEINTS D'UN SYNDROME HEPATORENAL DE TYPE 1 (METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1)
Poland	3209317
Poland	3978074
Australia	2022288996	METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1
European Patent Office	4351619	MÉTHODE DE TRAITEMENT DE PATIENTS ATTEINTS D'UN SYNDROME HÉPATORÉNAL DE TYPE 1 (METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1)
European Patent Office	3209317	MÉTHODE DE TRAITEMENT DE PATIENTS ATTEINTS D'UN SYNDROME HÉPATORÉNAL DE TYPE 1 (METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1)
China	117425488	治疗患有1型肝肾综合征的患者的方法 (Methods of treating patients with hepatorenal syndrome type 1)

TERLIPRESSIN ACETATE Market Analysis and Financial Projection Experimental

Terlipressin Acetate Market Dynamics and Financial Trajectory

Market Overview

The Terlipressin Acetate market is experiencing significant growth, driven by its efficacy in treating critical conditions such as hepatorenal syndrome (HRS) and acute variceal bleeding. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

As of 2023, the Terlipressin Acetate market was valued at USD 120 million and is projected to reach USD 200 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.1% from 2024 to 2031[2].

Segmentation

The market is segmented based on several key factors:

By Type

• The market is divided into two main types: Terlipressin Acetate with a purity of less than 98% and more than 98%[1][3].

By Application

• The primary applications include injection solutions and powder for injection. The drug is used for treating hepatorenal syndrome, acute variceal bleeding, cardiovascular conditions, and in clinical research[2][3].

By Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Europe and Asia-Pacific regions are expected to be significant contributors to the market growth due to the increasing prevalence of liver diseases and the availability of advanced healthcare infrastructure[1][2][3].

Drivers of Growth

Several factors are driving the growth of the Terlipressin Acetate market:

Increasing Prevalence of Liver Diseases

The rising incidence of liver diseases, such as hepatorenal syndrome, is a major driver. Hepatorenal syndrome affects approximately 8-10% of individuals with liver cirrhosis, creating a substantial demand for effective treatments[3].

Efficacy and Safety

Terlipressin Acetate has shown superior efficacy compared to other vasopressin analogs, with longer biological activity and fewer side effects. It is particularly effective in controlling acute variceal bleeding and reversing hepatorenal syndrome, making it a preferred choice in critical care settings[3][5].

Advancements in Pharmaceutical Formulations

Improvements in drug administration techniques and the development of new pharmaceutical formulations are enhancing the accessibility and uptake of Terlipressin Acetate. This includes the availability of injection solutions and powders for injection, which cater to different clinical needs[2].

Expanding Healthcare Infrastructure

The growth of medical facilities and healthcare infrastructure, especially in emerging markets, is making Terlipressin Acetate more accessible to a wider patient population. This expansion is supported by government initiatives and increasing investments in healthcare[2].

Challenges and Restraints

Despite the growth, the market faces several challenges:

Availability Issues

Terlipressin Acetate is not available in the United States and Canada, which restricts its global reach. However, it is available in many European countries, Australia, New Zealand, India, and the UAE[3].

Alternative Treatments

The presence of alternative treatments such as somatostatin, octreotide, and vapreotide can restrain the growth of the Terlipressin Acetate market. These alternatives may be preferred in certain regions or clinical scenarios[3].

Safety Concerns

While generally safe, Terlipressin Acetate is associated with serious adverse events such as respiratory failure, particularly in patients with advanced renal failure. Mitigation strategies are being developed to address these risks[5].

Competitive Landscape

The Terlipressin Acetate market is highly competitive, with several key players:

• Ferring Pharmaceuticals
• Bausch Health
• Pfizer
• GSK
• Merck & Co.
• Novartis
• Sanofi
• AbbVie
• Teva Pharmaceuticals
• Eli Lilly[2]

These companies are engaged in various strategies such as mergers and acquisitions, joint ventures, collaborations, and new product innovations to enhance their market presence[1].

Financial Performance and Projections

The financial trajectory of the Terlipressin Acetate market is promising, with significant revenue growth expected over the forecast period. Here are some key financial projections:

• Market Size: Expected to reach USD 200 million by 2031 from USD 120 million in 2023[2].
• CAGR: 6.1% from 2024 to 2031[2].
• Revenue Segments: The market revenue is segmented by type, application, and geography, with injection solutions and hepatorenal syndrome treatment being major contributors[2][3].

Key Takeaways

• The Terlipressin Acetate market is driven by its efficacy in treating hepatorenal syndrome and acute variceal bleeding.
• The market is expected to grow significantly, reaching USD 200 million by 2031.
• Key drivers include the increasing prevalence of liver diseases, advancements in pharmaceutical formulations, and expanding healthcare infrastructure.
• Challenges such as availability issues and safety concerns need to be addressed.
• The competitive landscape is dominated by several major pharmaceutical companies.

FAQs

What is the current market size of Terlipressin Acetate?

The Terlipressin Acetate market was valued at USD 120 million in 2023[2].

What is the projected growth rate of the Terlipressin Acetate market?

The market is expected to grow at a CAGR of 6.1% from 2024 to 2031[2].

What are the primary applications of Terlipressin Acetate?

The primary applications include treating hepatorenal syndrome, acute variceal bleeding, cardiovascular conditions, and use in clinical research[2][3].

Why is Terlipressin Acetate preferred over other treatments?

Terlipressin Acetate is preferred due to its longer biological activity and fewer side effects compared to other vasopressin analogs[3].

What are the major challenges facing the Terlipressin Acetate market?

Major challenges include availability issues in certain regions and the presence of alternative treatments. Safety concerns such as respiratory failure also need to be mitigated[3][5].

Cited Sources

1. Reports and Data: Terlipressin Acetate Market Trends, Revenue, Key Players, Growth, Share and Forecast Till 2027[1].
2. Market Research Intellect: Terlipressin Acetate Market Size, Share and Forecast to 2031[2].
3. Verified Market Research: In-Depth Industry Outlook: Terlipressin Market Size & Forecast[3].
4. WICZ: Terlipressin Acetate Market 2024: Growth Analysis by Strategic Developments[4].
5. VA.gov: Terlipressin (TERLIVAZ) in Hepatorenal Syndrome National Drug Monograph[5].