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TERLIVAZ Drug Patent Profile

When do Terlivaz patents expire, 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-five 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:	35
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	3,433
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	10,335,452
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
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

TERLIVAZ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TERLIVAZ (Terlipressin)

Introduction to TERLIVAZ

TERLIVAZ, also known as terlipressin, is a vasoconstrictor used primarily to treat type 1 hepatorenal syndrome (HRS-1), a serious complication that can occur in patients with cirrhosis of the liver. Here, we delve into the market dynamics and financial trajectory of this critical drug.

Market Size and Growth

The global terlipressin market, which includes TERLIVAZ, is projected to grow significantly over the coming years. The market size is expected to increase from USD 2.5 million in 2022 to USD 4.5 million by 2033, with a Compound Annual Growth Rate (CAGR) of 5.4% from 2023 to 2033[1].

Key Drivers of Market Growth

Increasing Incidence of Liver and Kidney Diseases

The rising incidence of liver and kidney diseases, particularly hepatorenal syndrome, is a major driver of the terlipressin market. This condition is often associated with cirrhosis and can lead to severe complications, making terlipressin a crucial treatment option[1].

Demographic Factors

The growing elderly population, especially in regions like Asia-Pacific, is another significant factor. Countries like India and China have large and aging populations, which are more prone to liver and kidney diseases, thereby boosting the demand for terlipressin[1].

Low Blood Pressure Among Adults and Elderly

The increasing prevalence of low blood pressure among adults and the elderly also contributes to the market growth. Terlipressin's ability to manage this condition makes it an attractive option for healthcare providers[1].

Market Segmentation

By Type

The terlipressin market is segmented into injections and other forms. The injection segment dominates the market due to its rapid onset of action compared to oral and subcutaneous routes. This segment is expected to continue its dominance over the forecast period[1].

By Region

The global terlipressin market is segmented across Europe, North America, the Middle East & Africa, Asia-Pacific, and South America. The Asia-Pacific region is projected to account for the highest market share, driven by the large and aging populations in countries like India and China[1].

Financial Performance of TERLIVAZ

Launch and Adoption

TERLIVAZ, launched by Mallinckrodt, has shown promising results since its introduction. The drug has gained formulary inclusion at more than 225 hospitals and has established a full team of 45 sales representatives to drive its adoption. Despite its recent market entry, TERLIVAZ has achieved significant traction, with net sales of $6.0 million in the first quarter of 2024[3][5].

Clinical Efficacy and Real-World Data

Real-world data presented at the American College of Gastroenterology (ACG) Annual Meeting highlighted the clinical efficacy of TERLIVAZ. The data showed that 47.6% of evaluable patients achieved HRS reversal, although the in-hospital mortality rate remained high at 17.6%. This data underscores the drug's effectiveness in treating severe cases of hepatorenal syndrome-acute kidney injury (HRS-AKI)[4].

Financial Results

Mallinckrodt's financial results reflect the positive momentum of TERLIVAZ. The company reported a 10.2% year-over-year growth in net sales for the first quarter of 2024, driven in part by the successful launch of TERLIVAZ. The Specialty Brands segment, which includes TERLIVAZ, saw a 2.1% increase in net sales, contributing to the overall growth[3][5].

Competitive Landscape

The terlipressin market is highly competitive, with companies like Mallinckrodt employing various strategies to enhance their market positions. These strategies include product launches, partnerships, acquisitions, agreements, and expansion of global operations. The focus on long-lasting partnerships and global expansion is crucial in this competitive landscape[1].

Challenges and Considerations

Conservative Adoption

Despite its efficacy, TERLIVAZ faces conservative adoption patterns due to its recent market entry and the serious safety concerns associated with it, such as the risk of fatal respiratory failure. This cautious approach by healthcare providers is reflected in the relatively low first-line usage rate of 20.8%[4].

Economic Volatility

The global economic volatility and the impact of the China-US trade war are expected to slow down the market growth over the forecasting period. This economic uncertainty can affect the overall demand and pricing strategies for terlipressin[1].

Key Takeaways

• Market Growth: The global terlipressin market is expected to grow from USD 2.5 million in 2022 to USD 4.5 million by 2033, driven by increasing liver and kidney diseases.
• Demographic Impact: The aging population, especially in Asia-Pacific, is a significant driver of market growth.
• Clinical Efficacy: TERLIVAZ has shown promising clinical efficacy, with 47.6% of patients achieving HRS reversal.
• Financial Performance: TERLIVAZ has contributed to Mallinckrodt's financial growth, with net sales of $6.0 million in the first quarter of 2024.
• Competitive Landscape: The market is highly competitive, with companies focusing on global expansion and long-lasting partnerships.
• Challenges: Conservative adoption due to safety concerns and economic volatility are key challenges.

FAQs

Q: What is the primary use of TERLIVAZ?

TERLIVAZ is primarily used to treat type 1 hepatorenal syndrome (HRS-1), a serious complication associated with cirrhosis of the liver.

Q: What is the expected market size of the global terlipressin market by 2033?

The global terlipressin market is expected to grow to USD 4.5 million by 2033.

Q: Which region is projected to account for the highest market share of terlipressin?

The Asia-Pacific region is projected to account for the highest market share due to its large and aging population.

Q: What are the key drivers of the terlipressin market growth?

The key drivers include the increasing incidence of liver and kidney diseases, demographic factors such as an aging population, and the growing prevalence of low blood pressure among adults and the elderly.

Q: What are the challenges faced by TERLIVAZ in terms of adoption?

TERLIVAZ faces conservative adoption patterns due to its recent market entry and serious safety concerns, such as the risk of fatal respiratory failure.

Sources

1. Market Statsville Group: Terlipressin Market Size, Share and Trends Analysis by 2033.
2. Mallinckrodt plc: Reports Second Quarter 2023 Financial Results.
3. PR Newswire: Mallinckrodt plc Reports First Quarter 2024 Financial Results and Reaffirms Full-Year Guidance.
4. Stock Titan: Mallinckrodt Presents Data on TERLIVAZ (terlipressin) for Injection in Patients with Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI).
5. Mallinckrodt plc: Reports First Quarter 2024 Financial Results and Reaffirms Full-Year Guidance.