Last Updated: May 10, 2026

Angiotensin ii acetate - Generic Drug Details


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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 sixty-four patent family members in twenty-five countries.

Two suppliers are listed for this compound.

Summary for angiotensin ii acetate
International Patents:64
US Patents:11
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 6
DailyMed Link:angiotensin ii acetate at DailyMed
Recent Clinical Trials for angiotensin ii acetate

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

SponsorPhase
Kasr El Aini HospitalN/A
Johns Hopkins UniversityPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 2

See all angiotensin ii acetate clinical trials

Pharmacology for angiotensin ii acetate
Drug ClassVasoconstrictor
Physiological EffectVasoconstriction
Medical Subject Heading (MeSH) Categories for angiotensin ii acetate
Anatomical Therapeutic Chemical (ATC) Classes for angiotensin ii acetate
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-003 Dec 23, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-002 Dec 21, 2017 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
La Jolla Pharma GIAPREZA angiotensin ii acetate SOLUTION;INTRAVENOUS 209360-001 Dec 21, 2017 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for angiotensin ii acetate

Country Patent Number Title Estimated Expiration
Mexico 380968 ANGIOTENSINA II SOLA O EN COMBINACION PARA EL TRATAMIENTO DE HIPOTENSION. (ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION.) ⤷  Start Trial
Brazil 112018013847 métodos para administrar a angiotensina ii ⤷  Start Trial
China 119700926 ⤷  Start Trial
European Patent Office 3400000 MÉTHODES D'ADMINISTRATION D'ANGIOTENSINE II (METHODS FOR ADMINISTERING ANGIOTENSIN II) ⤷  Start Trial
Japan 2019214610 ⤷  Start Trial
European Patent Office 3607962 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Angiotensin ii acetate Market Analysis and Financial Projection

Last updated: April 24, 2026

Angiotensin II Acetate Market Dynamics and Financial Trajectory

Angiotensin II acetate is an injectable angiotensin II formulation used to treat vasodilatory shock with hypotension that persists despite fluid resuscitation and catecholamine therapy. Commercial trajectory is driven by (1) clinical positioning versus vasopressors, (2) payer and hospital formulary adoption tied to evidence strength and guideline alignment, (3) tender and contracting mechanics for high-cost ICU products, and (4) regulatory and supply stability affecting continuity of treatment access.

What is the commercialization baseline for angiotensin II acetate?

Regulatory footprint and product identity

Angiotensin II acetate is marketed as Giapreza (angiotensin II) in the United States, where it is used in ICU settings for vasodilatory shock. The drug has a single dominant brand footprint in major markets and therefore the financial trajectory is tightly coupled to brand share and access rather than a multi-product competitive shelf.

Use case definition (commercial relevance)

The core commercial segment is ICU vasodilatory shock with hypotension despite standard therapy. That narrow label concentrates demand into hospitals with:

  • established shock pathways and protocolized vasopressor use,
  • ICU inventory management suitable for high-acquisition-cost injectables,
  • experience integrating new vasoactive agents into sepsis/shock bundles.

Pricing and purchasing behavior

For high-cost ICU medicines, gross-to-net economics typically depend on:

  • hospital contracts and group purchasing organization (GPO) dynamics,
  • payer coverage rules (prior authorization and step edits),
  • patient mix (severity drives utilization under label criteria),
  • and the ability to maintain continuous supply to avoid missed treatment windows.

Even without granular net price disclosure in the public record, the market behavior is consistent with specialty hospital injectable models: procurement is contract-led, use is protocol-driven, and retention depends on outcomes consistency in real-world practice.

How does demand generation work in hospitals?

Protocol adoption and treatment triggers

Angiotensin II acetate demand is primarily “protocol pull,” not “pharmacy shelf push.” Hospitals adopt when they can place it into an ICU workflow for refractory vasodilatory shock. Adoption accelerates when:

  • clinicians view it as a realistic escalation option after catecholamines,
  • ordering pathways reduce friction (rapid access vs delayed approval),
  • pharmacy and therapeutics committees are comfortable with safety monitoring needs.

Clinician switching is bounded

Switching from alternative vasopressors is constrained by:

  • familiarity and comfort with existing ICU shock algorithms,
  • evidence interpretation across patient phenotypes,
  • and local formulary constraints.

This limits organic share gains to centers willing to operationalize the drug and maintain supply.

Real-world utilization is sensitive to severity distribution

Because the indication targets persistent hypotension despite standard therapy, use volume rises with:

  • higher incidence of vasodilatory shock treated in the facility,
  • higher rates of refractory cases reaching the escalation step,
  • and longer ICU lengths of stay where vasopressor adjustments persist.

Supply continuity affects monthly revenue

For ICU injectables, stockouts can create irreversible demand loss (missed decision windows and clinician inertia). Revenue volatility is typically less about the brand’s unit demand ceiling and more about the reliability of supply and contracting continuity.

What are the key competitive dynamics?

Competitive set: vasopressor and shock escalation strategies

Angiotensin II is part of a broader shock management package. Competitive pressure comes from:

  • standard vasopressors (agents used before angiotensin II in practice),
  • dosing strategies that optimize response without escalation,
  • and alternative rescue therapies adopted under payer or guideline preferences.

The drug does not compete for general hypertension or outpatient markets. It competes inside a defined ICU escalation step, so competitive intensity is concentrated in hospital formularies and ICU protocols.

How evidence translates to formulary access

Formulary adoption tends to reward clear clinical utility for specific refractory profiles. Where outcomes benefits are perceived as robust for the eligible subgroup, coverage and stocking tighten. Where benefit is seen as inconsistent, adoption remains limited to select high-utilization ICUs.

How does payer coverage shape revenue trajectory?

Coverage hurdles

High-cost inpatient injectables typically face:

  • prior authorization or clinical criteria edits,
  • documentation requirements to confirm refractory hypotension after standard therapy.

These controls impact the conversion of eligible patients into treated patients and can slow revenue ramp even when clinical uptake exists.

Net price dynamics

Because contracting is the primary revenue lever, financial trajectory is more sensitive to gross-to-net mechanics than to list price. Hospital systems can negotiate volume discounts tied to utilization forecasts and procurement cadence.

Institutional contracting cycles create step-changes

Revenue often shows lumpy behavior aligned to:

  • annual contract renewals,
  • GPO alignment changes,
  • formulary committee cycles.

These dynamics can produce periods of accelerated adoption followed by slower conversion if contract terms or access constraints tighten.

What does the financial trajectory typically look like for angiotensin II acetate?

Phase model for commercial performance

The commercialization path for an ICU-specific, high-acquisition-cost injectable typically follows four phases:

  1. Initial ramp

    • Uptake begins in early-adopter centers with strong shock protocols.
    • Sales growth depends on center-level education, contracting, and supply stability.
  2. Protocol expansion

    • Adoption broadens across hospitals where the drug becomes a routine rescue option.
    • Revenue growth becomes more predictable but remains bounded by eligibility frequency.
  3. Competitive and payer gating

    • Formularies may tighten under cost scrutiny or shift preferences toward competing strategies.
    • Utilization growth slows as the remaining eligible population becomes less accessible due to coverage edits.
  4. Maturity and refinement

    • Market stabilizes at the penetration of institutions willing to stock and trigger use appropriately.
    • Revenue is maintained through supply reliability, inventory discipline, and contract retention.

This phase pattern is consistent with the way hospital-based specialty injectables mature: the ceiling is driven by refractory vasodilatory shock incidence and institutional adoption rather than broad indication expansion.

Major revenue drivers

Angiotensin II acetate revenue is most influenced by:

  • eligible patient counts (vasodilatory shock refractory to catecholamines),
  • percentage of eligible patients receiving the drug (coverage and protocol adoption),
  • dosing and treatment duration under label conditions,
  • and contracting and payer mix affecting net price.

What is the likely forward outlook based on market structure?

Short-to-mid term: bounded by ICU incidence and access

Near-term performance is constrained by:

  • stable ICU epidemiology for vasodilatory shock,
  • persistent competition among shock escalation regimens,
  • and continued payer control on qualifying refractory patients.

Upside levers

The key upside levers are:

  • expansion of center penetration within hospital systems already inclined to use the drug,
  • improved payer acceptance via established clinical criteria and administrative precedent,
  • and any supply normalization that reduces treatment denials due to inventory constraints.

Downside levers

Main downside risks are:

  • preference shifts to alternative vasopressor escalation approaches,
  • unfavorable contracting terms or tighter payer edits,
  • and institutional budget pressure limiting formulary commitment.

Commercial implications for investors and R&D planners

Market sizing is operational, not just epidemiological

For angiotensin II acetate, the actionable market size is:

  • number of ICU beds in institutions that can operationalize the drug,
  • plus the proportion of refractory vasodilatory shock cases reaching the treatment trigger,
  • multiplied by expected conversion after payer and protocol gating.

Epidemiology alone will overstate revenue if access is constrained.

Formulary penetration is the central KPI

Financial trajectory aligns with:

  • number of institutions stocking the drug,
  • persistence of those contracts through renewal cycles,
  • and real-world usage per eligible patient.

Safety and handling are “commercial features”

For ICU injectables, risk management affects adoption pace:

  • monitoring requirements,
  • workflow fit in ICU medication administration,
  • and clinician confidence in consistent response.

Even if clinical utility is strong, operational friction slows conversion.

Key Takeaways

  • Angiotensin II acetate commercial demand is concentrated in ICU vasodilatory shock with persistent hypotension despite catecholamines, making revenue path dependent on institutional protocol adoption and payer conversion rather than broad market expansion.
  • Financial trajectory typically follows an early-adopter ramp into protocol expansion, then slows as formulary and payer gating tighten and competitive shock strategies shift.
  • Net revenue behavior is driven by hospital contracting cycles and gross-to-net dynamics, with potential step-changes at renewals and year-end procurement periods.
  • Supply reliability and continuity of access materially affect monthly outcomes in inpatient ICU products because missed treatment windows reduce repeat adoption.

FAQs

  1. Is angiotensin II acetate a broad-market drug?
    No. Sales concentrate in ICU vasodilatory shock patients with persistent hypotension despite catecholamines.

  2. What most determines short-term revenue?
    Eligible case conversion after payer and protocol gating, plus contracting-driven net pricing in hospital systems.

  3. What is the main channel for adoption?
    Hospital formulary and ICU protocol integration rather than outpatient retail distribution.

  4. Does competition come from other shock drugs or from within the same class?
    Competition comes from alternative vasopressor and shock escalation strategies used before angiotensin II in standard workflows.

  5. What should be monitored for trajectory changes?
    Contract renewals, stocking breadth across hospital systems, prior authorization behavior, and supply continuity.

References

[1] U.S. Food and Drug Administration. “Giapreza (angiotensin II) Prescribing Information.” FDA label.

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