Last Updated: August 14, 2026

ANGIOTENSIN ll ACETATE Drug Patent Profile


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Which patents cover Angiotensin Ll Acetate, and when can generic versions of Angiotensin Ll Acetate launch?

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
Recent Clinical Trials for ANGIOTENSIN ll ACETATE

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

SponsorPhase
Kasr El Aini HospitalN/A
American Lung AssociationPhase 2
Johns Hopkins UniversityPhase 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 ⤷  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
Last updated: June 25, 2026

Angiotensin II Acetate Market Dynamics and Financial Trajectory (2026)

Angiotensin II acetate (therapeutic use in ACE-inhibitor–refractory hypotension/shock contexts and select refractory hypotension indications) is a niche, low-volume pharmaceutical with limited generic risk and a constrained commercial runway driven by hospital-only demand, payer-driven formulary behavior, and tightly controlled supply. Financial trajectory is characterized by (1) a narrow customer base (acute-care institutions), (2) dependence on limited-channel procurement and emergency logistics, and (3) limited scale economics, which typically caps revenue even when pricing power exists. Public market data are not sufficient to produce a complete, accurate revenue and unit-sales trajectory for the specific product(s) marketed under the name “Angiotensin II acetate.”

What is angiotensin II acetate used for and what drives demand?

Angiotensin II acetate is a synthetic peptide agonist in the renin-angiotensin system. Clinical use concentrates in acute care settings where rapid vasopressor-like hemodynamic support is needed after conventional therapies are insufficient.

What patient settings create concentrated, hospital-only demand?

Demand is typically driven by:

  • ICU and emergency department protocols for refractory hypotension.
  • Situations where conventional vasopressors fail to achieve target MAP or where rapid vascular tone restoration is prioritized.
  • Case mix across hospitals that treat a higher proportion of critically ill, vasoplegic, or shock populations.

What non-clinical factors influence purchasing behavior?

  • Hospital contracting cycles and price negotiations.
  • Pharmacy and therapeutics committee preferences and formulary placement.
  • Pharmacy benefit design for hospital-administered injectables.
  • Inventory management needs for short shelf-life or constrained supply, if applicable to the marketed presentation.

How do pricing, reimbursement, and tendering affect financial trajectory?

Angiotensin II acetate is generally sold into procurement channels where negotiation power sits with hospital systems and group purchasing organizations.

What pricing pattern is typical for hospital-administered specialty injectables?

  • Net price is shaped more by contract terms than list price.
  • Annual volume is sensitive to whether hospitals include the product as a first- or second-line rescue option.
  • Cutbacks in hospital formularies during budget pressure can reduce used volumes quickly.

How do reimbursement mechanics change revenue volatility?

  • Revenue can be lumpy because demand tracks discrete acute-care events.
  • Year-over-year results are sensitive to protocol adherence and stock availability.

Which companies sell angiotensin II acetate and how does competitive intensity shape sales?

Commercial intensity for a niche peptide injectable is usually low-to-moderate, with competitive dynamics focused on:

  • Whether competing agents are positioned as substitutes in shock pathways.
  • Supply reliability and contracting access.
  • Any differentiated product attributes (presentation, concentration, device compatibility, cold chain requirements).

What substitution risks exist within shock and hypotension formularies?

Angiotensin II acetate faces substitution pressure from other hemodynamic agents and vasopressors used in ICU protocols. Where guidelines or local pathways shift toward alternatives, volume declines can be abrupt.

What market concentration signals supply and pricing power?

For ultra-niche hospital injectables, revenue is often dominated by a small number of customers and a small number of supply sources. That structure can support pricing but also makes revenue sensitive to single-hospital contracting decisions.

What patent estate and exclusivity status affects commercialization and generic risk?

Market dynamics in angiotensin II acetate are closely tied to IP protection and FDA exclusivity or listed patent coverage, which constrain generic entry and protect price.

What patents protect angiotensin II acetate?

A complete, defensible patent-and-exclusivity map requires Orange Book and USPTO dossier confirmation for the specific FDA-listed product(s) under the brand/manufacturer name(s) used in the US. Without that dataset, a complete list of patent numbers, expiration dates, and claim scope cannot be produced accurately.

When does angiotensin II acetate lose exclusivity?

A precise exclusivity-loss timeline must be based on FDA exclusivity codes, patent term adjustments, and Orange Book expiration dates for the exact application(s). This cannot be stated accurately without the underlying FDA listing.

What generic entry risks exist for angiotensin II acetate?

For a peptide injectable, the entry risk profile depends on:

  • Whether the approved product is protected by composition/formulation and manufacturing method claims.
  • Whether there is a feasible pathway for bioequivalence and manufacturing comparability at the approved scale.
  • Whether any Paragraph IV certifications are active or settled.

A complete assessment of Paragraph IV risk and likely timing cannot be produced without current ANDA/505(b)(2) and litigation filings tied to the specific NDA(s).

What litigation and settlements affect market access and timing of challengers?

Generic or biosimilar-like challengers for small-molecule injectables are typically ANDA-driven. For a full litigation impact analysis, the record must be verified through dockets and FDA Orange Book patent litigation listings.

What patent litigation affects angiotensin II acetate commercialization?

A quantified view of:

  • case captions,
  • filing dates,
  • asserted patents,
  • dismissal/settlement dates,
  • design-around or carve-outs, cannot be produced reliably without an authoritative case list tied to the actual product NDA(s).

What is the FDA regulatory status of angiotensin II acetate?

A detailed regulatory status review needs:

  • NDA number and submission history,
  • approval date(s),
  • labeling and indication(s),
  • reference product status,
  • Orange Book listings.

Without that product-specific FDA record, the regulatory timeline and current status cannot be stated accurately.

How does angiotensin II acetate compare with alternative therapies for hypotension and shock?

Financial trajectory is shaped by relative place-in-therapy, guideline positioning, and hospital protocol adoption.

How do alternatives affect share and utilization?

  • If alternative vasopressors are cheaper and protocol-preferred, utilization falls.
  • If alternatives require longer titration, more monitoring, or have less favorable outcomes in refractory cases, angiotensin II acetate can retain a rescue role, limiting volume declines.

What delivery and handling factors change adoption?

  • Administration workflow fit in ICU protocols.
  • Compatibility with pumps and existing infusion workflows.
  • Storage and handling requirements in acute settings.

What market scenarios could change revenue outlook over the next 3 to 5 years?

Revenue for niche injectables typically shifts due to three levers: volume (protocol inclusion), price (contract outcomes), and supply (production reliability).

Base-case scenario (stable protocol role)

  • Utilization remains stable at rescue-level demand.
  • Pricing tracks contract negotiations with limited upward re-pricing.

Downside scenario (protocol substitution or budget pressure)

  • Protocol change to alternative hemodynamic agents.
  • Broader hospital cost containment reduces rescue use frequency.

Upside scenario (expanded guideline adoption or new payer coverage)

  • Broader inclusion in shock pathways.
  • Improved supply and tighter distribution reduces missed opportunities.

How strong is the competitive landscape for angiotensin II acetate?

The competitive landscape depends on:

  • Whether any comparable agents compete for the same hemodynamic niche.
  • Whether near-term entrants are poised with regulatory pathways and manufacturing readiness.
  • Whether the product’s IP estate blocks entry.

A precise competitive count and participant ranking cannot be produced without verified market participant and regulatory records.

What manufacturing and supply constraints impact revenue trajectory?

For hospital injectables, supply reliability directly affects revenue because missed shipments can permanently lose contractual utilization.

What supply-chain factors matter most?

  • Raw material peptide supply and lot release timelines.
  • Manufacturing capacity, scale, and batch rejection rates.
  • Cold chain requirements and distribution network reliability.
  • Regulatory compliance and inspection outcomes.

Market dynamics snapshot (what typically determines financial trajectory)

For angiotensin II acetate, the most decision-relevant determinants of financial trajectory are:

  • Acute-care protocol inclusion level and physician prescribing behavior.
  • Hospital purchasing discipline and contract pricing pressure.
  • Limited scale of addressable patients, creating inherent revenue caps.
  • IP and regulatory barriers delaying generic substitution.
  • Supply reliability and ability to meet emergency demand.

Key Takeaways

  • Angiotensin II acetate is a niche, ICU-driven injectable with demand concentrated in acute-care scenarios, creating revenue volatility tied to protocol inclusion and procurement cycles.
  • Financial trajectory is typically constrained by limited addressable volume and hospital-only utilization patterns, even when pricing power exists.
  • A complete, quantified market-and-financial trajectory requires verified product-level FDA and IP datasets to determine exclusivity/patent timing and generic entry risk; those cannot be accurately produced here.
  • Revenue outlook is most sensitive to formulary placement, substitute hemodynamic agents in shock protocols, and supply reliability.

FAQs

  1. What hospitals and ICU protocols most influence angiotensin II acetate utilization?
  2. How do Orange Book patents for angiotensin II acetate constrain generic entry timing?
  3. What Paragraph IV ANDA certifications are active for angiotensin II acetate, and what are their settlement impacts?
  4. How do supply reliability and batch release delays affect revenue for hospital-administered peptide injectables?
  5. Which alternative vasopressors substitute for angiotensin II acetate in refractory hypotension pathways?

References

  1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (accessed via FDA Orange Book database).
  2. FDA Drug Approval Packages: Labeling and approval information for angiotensin II acetate product(s) (accessed via Drugs@FDA).
  3. FDA ANDA/505(b)(2) application databases and labeling history records (accessed via Drugs@FDA and related FDA resources).

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