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Last Updated: December 15, 2025

ANGIOTENSIN LL ACETATE Drug Patent Profile


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Which patents cover Angiotensin Ll Acetate, and what generic alternatives are available?

Angiotensin Ll Acetate is a drug marketed by Gland and is included in one NDA.

The generic ingredient in ANGIOTENSIN LL ACETATE is angiotensin ii acetate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the angiotensin ii acetate profile page.

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Summary for ANGIOTENSIN LL ACETATE
Drug patent expirations by year for ANGIOTENSIN LL ACETATE
Recent Clinical Trials for ANGIOTENSIN LL ACETATE

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SponsorPhase
Kasr El Aini HospitalN/A
National Heart, Lung, and Blood Institute (NHLBI)Phase 2
American Lung AssociationPhase 2

See all ANGIOTENSIN LL ACETATE clinical trials

Pharmacology for ANGIOTENSIN LL ACETATE
Drug ClassVasoconstrictor
Physiological EffectVasoconstriction

US Patents and Regulatory Information for ANGIOTENSIN LL ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland ANGIOTENSIN LL ACETATE angiotensin ii acetate SOLUTION;INTRAVENOUS 216966-001 Jun 3, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Angiotensin II Acetate

Last updated: August 2, 2025

Introduction

Angiotensin II Acetate is a synthetic analog of angiotensin II, a potent peptide hormone involved in vasoconstriction and blood pressure regulation. It has become an important therapeutic agent in managing acute hypotensive states, especially in critical care settings. Its unique pharmacological profile and clinical utility have influenced its market trajectory, driven by evolving healthcare demands, regulatory landscapes, and technological advancements. This report delineates the market dynamics and financial prospects for Angiotensin II Acetate, highlighting key factors shaping its commercial landscape.

Pharmacological Profile and Clinical Uses

Angiotensin II Acetate acts as a direct vasoconstrictor, increasing systemic vascular resistance and elevating blood pressure. Approved by U.S. Food and Drug Administration (FDA) in 2017 under the brand name Giapreza, it primarily addresses vasodilatory shock that is unresponsive to conventional vasopressors. Clinical trials demonstrate its efficacy in increasing mean arterial pressure (MAP), especially in critical care scenarios involving vasoplegia—common in septic shock and during cardiovascular surgeries. Its targeted mechanism offers a more precise intervention compared to broader vasopressors, positioning it as a specialized option in intensive care protocols.

Key Market Drivers

Growing Incidence of Critical Care Conditions

The rising prevalence of septic shock, cardiogenic shock, and other forms of vasodilatory shock globally propels demand for potent vasopressors like Angiotensin II Acetate. According to the Global Sepsis Alliance, sepsis affects over 49 million people annually, with mortality rates ranging from 25% to 30% in critical cases [1]. The increasing burden of such conditions necessitates effective vasopressor therapies, augmenting the market for Angiotensin II Acetate.

Advancements in Critical Care

Improvements in intensive care unit (ICU) management, better diagnostic tools, and the adoption of personalized medicine strategies bolster the use of targeted vasopressors. Angiotensin II Acetate’s specific action profile aligns with precision medicine trends, encouraging its incorporation into treatment ladders for refractory shock scenarios.

Regulatory Approvals and Reimbursement Policies

FDA approval in 2017 significantly bolstered market confidence, with subsequent approvals in Europe and other regions expanding access. Supportive reimbursement policies for critical care pharmaceuticals further incentivize hospital procurement. As healthcare systems prioritize high-cost, high-efficacy interventions, Angiotensin II Acetate benefits from favorable coverage decisions.

Limited Competition and Patent Protection

Initially, Angiotensin II Acetate faced limited competition due to its novel mechanism and regulatory barriers. While generic versions may eventually emerge, current patent protections and manufacturing complexities sustain higher pricing models.

Market Challenges

High Cost and Limited Indications

A major obstacle is the drug’s high price point—approximately $1,200 per vial—posing financial burdens on healthcare systems, especially in low- to middle-income countries. Its narrow application window restricts broader use, potentially limiting volume sales.

Clinical Adoption Barriers

Despite proven efficacy, clinicians sometimes exhibit hesitancy due to concerns over adverse effects like ischemia or arrhythmias, and limited familiarity with the drug compared to traditional vasopressors such as norepinephrine. Educational initiatives are necessary to enhance adoption.

Manufacturing Complexity

The synthesis of Angiotensin II Acetate involves sophisticated peptide manufacturing processes, leading to higher production costs and potential supply constraints.

Financial Trajectory and Market Forecast

Market Size and Growth Potential

The global vasopressor market was valued at approximately $2.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6%-8% through the next five years [2]. Angiotensin II Acetate, as a specialized agent, constitutes a niche but lucrative segment within this market.

Revenue Projections

By 2027, estimations suggest that Angiotensin II Acetate could generate annual revenues exceeding $300 million, factoring in increased adoption in critical care units, expanded regional approvals, and growing awareness. The United States is expected to dominate sales, given its advanced healthcare infrastructure and higher ICU admission rates.

Market Penetration Strategies

Key strategies include expanding clinical evidence through post-market studies, broadening approved indications (e.g., refractory shock in pediatric populations), and fostering partnerships with hospital systems. Due to high costs, payers’ willingness to reimburse will directly impact adoption rates.

Impact of Biosimilars and Generics

The entry of biosimilar products could alter pricing dynamics, potentially reducing costs and expanding access. However, the complex manufacturing process and regulatory pathways may delay such entries, sustaining current high-margin revenues.

Emerging Technological Trends

Innovations in peptide synthesis, formulation improvements, and delivery mechanisms (e.g., infusion pumps with precise dosing) may reduce costs and facilitate wider application, influencing long-term financial trajectories favorably.

Regulatory and Geographic Expansion Potential

While approvals are concentrated mainly in North America and Europe, emerging markets such as Asia-Pacific possess significant growth potential given increasing healthcare investments and rising critical care patient populations. Regulatory engagement and strategic pricing will determine success in these regions.

Competitive Landscape

The market primarily revolves around Giapreza (purchased by Abiomed), with minimal direct competitors as of 2023. The absence of significant entrants underscores the drug’s market exclusivity but also reveals vulnerability to future biosimilar developments. Ongoing clinical research and real-world evidence will shape competitive positioning.

Key Market Challenges and Opportunities

Challenges Opportunities
High drug cost Expansion into emerging markets
Restricted indications Broadening clinical evidence base
Clinician apprehension Education and clinical guideline integration
Manufacturing complexity Process technological advancements

Conclusion

Angiotensin II Acetate’s market dynamics revolve around its niche positioning within critical care pharmacotherapy, driven by the rising burden of shock-related conditions. Its financial prospects are promising, anchored by the expanding global ICU population, regulatory endorsements, and limited competition. However, high costs, clinical adoption barriers, and manufacturing complexities remain critical considerations. Strategic efforts in evidence generation, market expansion, and cost reduction could significantly influence its long-term financial trajectory.

Key Takeaways

  • The global vasopressor market, valued at over $2.3 billion, is poised for sustained growth, with Angiotensin II Acetate occupying a specialized segment.
  • Rising critical care needs, coupled with regulatory approvals, position the drug for increased adoption, with revenues potentially surpassing $300 million annually by 2027.
  • High treatment costs and narrow indications limit widespread use; addressing these through evidence and pricing strategies could unlock broader market access.
  • Supply chain efficiencies and biosimilar developments may influence price dynamics and market competitiveness in the coming years.
  • Expansion into emerging markets and additional clinical indications offer significant upside for future growth.

References

[1] Global Sepsis Alliance. "Sepsis Facts & Figures." 2021.
[2] Global Market Insights. "Vasopressor Market Analysis & Trends." 2022.

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