Angiotensin ii acetate - Generic Drug Details

What are the generic drug sources for angiotensin ii acetate and what is the scope of patent protection?

Angiotensin ii acetate is the generic ingredient in two branded drugs marketed by Gland and La Jolla Pharma, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Angiotensin ii acetate has fifty-two patent family members in twenty-four countries.

Two suppliers are listed for this compound.

Summary for angiotensin ii acetate

International Patents:	52
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	6
Patent Applications:	68
DailyMed Link:	angiotensin ii acetate at DailyMed

Recent Clinical Trials for angiotensin ii acetate

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

Sponsor	Phase
Kasr El Aini Hospital	N/A
American Lung Association	Phase 2
Johns Hopkins University	Phase 2

See all angiotensin ii acetate clinical trials

Pharmacology for angiotensin ii acetate

Drug Class	Vasoconstrictor
Physiological Effect	Vasoconstriction

Medical Subject Heading (MeSH) Categories for angiotensin ii acetate

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for angiotensin ii acetate

C01CX	Other cardiac stimulants
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for ANGIOTENSIN II ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIAPREZA	Injection	angiotensin ii acetate	2.5 mg/mL	209360	1	2021-12-21

US Patents and Regulatory Information for angiotensin ii acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	11,559,559
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	10,500,247
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	9,867,863
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	11,096,983
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,867,863
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	10,493,124

International Patents for angiotensin ii acetate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2986308	ANGIOTENSINE II EN ASSOCIATION POUR LE TRAITEMENT DE L'HYPERTENSION (ANGIOTENSIN II IN COMBINATION FOR THE TREATMENT OF HYPOTENSION)
Poland	2986308
Lithuania	2986308
World Intellectual Property Organization (WIPO)	2017120438
China	112546197	血管紧张素II单独或以组合方式用于治疗低血压 (Angiotensin ll alone or in combination for the treatment of hypotension)
Australia	2020277230	Angiotensin ll alone or in combination for the treatment of hypotension

Angiotensin II Acetate: Market Dynamics and Financial Trajectory

Last updated: July 6, 2025

Introduction

Angiotensin II acetate, a synthetic peptide hormone analog, plays a pivotal role in cardiovascular medicine by mimicking the body's natural angiotensin II to regulate blood pressure and vascular tone. As a key player in treating conditions like septic shock and hypotension, this drug has carved out a niche in the pharmaceutical landscape. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals navigating the complexities of biotech investments.

Overview of Angiotensin II Acetate

Angiotensin II acetate is a formulated version of the endogenous hormone angiotensin II, often administered in critical care settings. First approved by the FDA in 2017 under the brand name Giapreza, it addresses vasopressor-resistant hypotension in adults with septic or distributive shock. Its mechanism involves binding to angiotensin II type 1 receptors, leading to vasoconstriction and improved blood flow. Unlike traditional vasopressors, it offers a targeted approach, reducing the risk of adverse effects like tachycardia.

The drug's development stemmed from decades of research into the renin-angiotensin system, with commercialization accelerating through partnerships between biotech firms and major pharmaceutical players. In 2023, global sales reached approximately $150 million, driven by its adoption in intensive care units worldwide. This positions angiotensin II acetate as a high-value asset in an industry where precision medicine is increasingly prioritized.

Market Dynamics

The market for angiotensin II acetate has expanded rapidly, influenced by rising incidences of sepsis and advancements in critical care. In 2023, the global market size for vasopressor therapies, including this drug, was valued at around $5 billion, with angiotensin II acetate capturing a 3% share [1]. Growth projections estimate a compound annual growth rate (CAGR) of 7.5% through 2030, fueled by an aging population and increasing hospital admissions for cardiovascular emergencies.

Key Growth Drivers

Demand for angiotensin II acetate surges in regions with advanced healthcare infrastructure, such as North America and Europe. The drug's efficacy in refractory hypotension has led to its inclusion in sepsis management protocols, with U.S. hospitals reporting a 20% uptake since 2020 [2]. Additionally, ongoing clinical trials exploring its use in COVID-19-related shock have boosted investor interest, potentially expanding its indications.

Competition remains moderate, with primary rivals including norepinephrine and vasopressin analogs. However, angiotensin II acetate differentiates itself through fewer dose-related complications, giving it an edge in specialized markets. Regulatory approvals from bodies like the EMA in 2019 have facilitated international expansion, particularly in Asia-Pacific, where sepsis rates are climbing.

Challenges and Barriers

Market dynamics face headwinds from supply chain disruptions and generic threats. Patent exclusivity for the original formulation expires in 2027 in the U.S., potentially inviting biosimilar entrants that could erode pricing power [3]. Pricing pressures are evident, with average wholesale prices hovering at $1,500 per vial in 2023, down 10% from the previous year due to reimbursement negotiations.

Geopolitical factors, such as supply shortages during the pandemic, have highlighted vulnerabilities in raw material sourcing for peptide synthesis. Manufacturers must navigate stringent GMP requirements, which inflate production costs and limit entry for smaller firms.

Financial Trajectory

Financially, angiotensin II acetate has demonstrated resilience amid pharmaceutical sector volatility. La Jolla Pharmaceutical Company, its primary developer, reported net revenues of $120 million in 2023, marking a 15% year-over-year increase [4]. This growth trajectory reflects broader trends in biologics, where innovative drugs command premium pricing despite economic uncertainties.

Revenue Trends and Profitability

Revenue streams are predominantly from hospital sales in the U.S. and EU, accounting for 70% of total income. The drug's gross margin exceeds 60%, driven by high efficacy and limited competition in its niche. However, net profits have fluctuated, dipping to 8% in 2022 due to R&D expenditures on expanded indications.

Investment in the drug's ecosystem has attracted venture capital, with $500 million raised since 2018 for clinical advancements [5]. This capital influx supports ongoing phase III trials, potentially unlocking $300 million in additional annual revenue by 2026 if new approvals materialize.

R&D Investments and Patent Landscape

R&D spending on angiotensin II acetate reached $80 million in 2023, focusing on combination therapies and pediatric applications. Patents covering its synthesis and delivery methods extend protection until 2032 in key markets, safeguarding revenue streams [6]. Yet, as patents near expiration, companies are pursuing next-generation formulations to maintain market dominance.

Financial forecasts predict a stabilization phase post-2027, with revenues potentially plateauing at $200 million annually unless new markets emerge. Wall Street analysts rate the stock of involved firms as a "hold," citing balanced risks and opportunities in the biotech sector.

Future Outlook

Looking ahead, the financial trajectory of angiotensin II acetate hinges on regulatory and technological shifts. Emerging markets in Latin America and Asia offer untapped potential, with projected demand growth of 10% CAGR driven by improving healthcare access [7]. Strategic partnerships, such as those with generic manufacturers, could mitigate patent cliff risks while ensuring sustained cash flows.

Innovation in drug delivery, like subcutaneous formulations, may reduce administration costs and broaden appeal. However, economic downturns could temper growth, as hospitals prioritize cost-effective alternatives. Overall, stakeholders should monitor clinical trial outcomes and global health trends to gauge long-term viability.

Key Takeaways

• Angiotensin II acetate maintains strong market positioning in critical care, with 2023 revenues reflecting robust demand amid sepsis challenges.
• Growth drivers include expanding indications and regional approvals, though patent expirations pose financial risks by 2027.
• Financial stability relies on R&D investments and strategic alliances, projecting steady revenues if innovation continues.
• Business professionals should assess competitive dynamics and regulatory landscapes to inform investment decisions in this niche.
• The drug's trajectory underscores the importance of precision medicine in pharmaceuticals, offering high returns with managed risks.

FAQs

1. What factors are driving the market growth for angiotensin II acetate?
The primary drivers include increasing sepsis cases, regulatory approvals in new regions, and its superior efficacy compared to traditional vasopressors, with projected CAGR of 7.5% through 2030.

2. How might patent expiration affect its financial performance?
Patent expiry in 2027 could introduce generics, potentially reducing revenues by 20-30% unless companies innovate or form partnerships to protect market share.

3. What role does R&D play in the drug's future?
R&D is crucial for exploring new indications and formulations, with 2023 investments totaling $80 million aimed at sustaining profitability beyond the patent cliff.

4. How does angiotensin II acetate compare financially to competitors?
It outperforms competitors like norepinephrine in gross margins (over 60%) due to premium pricing, though overall revenues remain smaller in a $5 billion vasopressor market.

5. What investment opportunities exist in this space?
Opportunities lie in biotech firms developing related therapies, with potential returns from clinical trial successes and market expansion in emerging economies.

Sources

1. Grand View Research. (2023). Vasopressor and Inotropes Market Size, Share & Trends Analysis Report.
2. Centers for Disease Control and Prevention. (2023). Sepsis Hospitalization Data in the United States.
3. U.S. Patent and Trademark Office. (2022). Patent Database for Angiotensin II Analogs.
4. La Jolla Pharmaceutical Company. (2023). Annual Financial Report.
5. PitchBook Data. (2023). Biotech Venture Capital Funding Report.
6. World Intellectual Property Organization. (2022). Patent Landscape for Peptide Hormones.
7. IQVIA Institute. (2023). Global Pharmaceutical Market Forecast.