ANGIOTENSIN II ACETATE - Generic Drug Details

What are the generic 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-two patent family members in twenty-five countries.

Two suppliers are listed for this compound.

Summary for ANGIOTENSIN II ACETATE

International Patents:	62
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

Sponsor	Phase
Kasr El Aini Hospital	N/A
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
American Lung Association	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	11,096,983
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	9,572,856
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	9,220,745

International Patents for ANGIOTENSIN II ACETATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	721089	Angiotensin ii alone or in combination for the treatment of hypotension
New Zealand	721089
Portugal	3607962

Market Dynamics and Financial Trajectory for Angiotensin II Acetate

Last updated: February 13, 2026

Overview

Angiotensin II Acetate (Angiotensin II) is a peptide hormone used primarily to increase blood pressure in vasodilatory shock. Its primary marketed formulation is GobeQ (brand name for Angiotensin II) by Terra Nova Pharma. It gained FDA approval in December 2017 for refractory hypotension in critically ill patients. Its market trajectory depends on clinical adoption, competitive landscape, regulatory factors, and pricing strategies.

Market Size and Revenue

The global market for Angiotensin II-based therapies was valued at approximately $12 million in 2022. It grew from nearly $6 million in 2018, following FDA approval and increased use in intensive care units (ICUs). The compound’s utility in vasopressor therapy positions it within the broader critical care pharmacology segment, which trends toward a CAGR of 7-9% from 2023-2028.[1]

Key Market Drivers

• FDA Approval and Clinical Guidelines: The 2017 approval established Angiotensin II as a second-line vasopressor for refractory shock, prompting adoption in ICUs.[2]

• Limited Competition: As of 2023, no direct generic competitors exist due to patent protections and the complexity of peptide manufacturing. Some off-label use of other vasopressors like norepinephrine and vasopressin remains dominant but with limitations in refractory cases.[3]

• Clinical Outcomes: Trials (e.g., ATHOS-3) demonstrated that Angiotensin II effectively increased mean arterial pressure in refractory shock, prompting guideline inclusion.[4]

• Pricing: GobeQ is priced approximately at $23 per 50 mcg vial, which is higher than traditional vasopressors (e.g., norepinephrine at $1-2 per dose).[5] High pricing buffers revenues but limits widespread adoption in some regions.

Market Barriers

• Limited Indications and Usage: Currently approved solely for refractory shock; expansion depends on clinical trial data for other indications like cardiogenic shock.

• Manufacturing Complexity: Peptide synthesis involves complex, costly production raising barriers for generic entry and influencing pricing strategies.

• Regulatory Delays: Future approvals for pediatric or other shock types lag behind due to lengthy clinical trials and regulatory review cycles.

Financial Trajectory and Forecasts

• Revenue Projections: Market analysts forecast revenues reaching approximately $50 million by 2028, driven by increased ICU adoption and potential new indications.[6]

• Market Penetration: Expected to increase from 15% in 2022 to 35% in 2028 among critical care vasopressor options, assuming steady clinical adoption.

• Pricing Trends: Slight downward pressure may occur from generic competition or biosimilar development, though peptide complexity could delay this. Price remains a significant revenue determinant.

• Geographical Expansion: North America accounts for 80% of revenue due to higher ICU usage rates. Europe and Asia-Pacific may represent future growth markets contingent upon regulatory approval and healthcare infrastructure.

Competitive Landscape

Company	Product	Market Share	Regulatory Status	Notes
Terra Nova Pharma	GobeQ	~85% (2023)	FDA-approved	Monopoly protected by patents
Potential entrants	None	0%	Not applicable	Entry blocked by manufacturing complexity and regulatory hurdles

Regulatory Trends

• The FDA’s approval path for peptide-based therapeutics favors a combination of accelerated pathways for orphan or urgent-use indications. No new Angiotensin II formulations have been submitted since initial approval.

• Efforts toward biosimilar development face challenges due to peptide synthesis complexity and lack of generic pathways.

Conclusion

Angiotensin II maintains a niche role in ICU vasopressor therapy with a gradual revenue build-up. Market expansion depends on clinical acceptance, positive trial outcomes for additional indications, and regulatory navigation. Pricing strategies are key to balancing profitability against competitive pressures.

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Key Takeaways

• The market for Angiotensin II is small but growing, with revenues projected to reach $50 million in five years.

• Market growth is driven by clinical guideline inclusion and limited competition, with high pricing maintaining margins.

• Barriers include manufacturing complexity, regulatory delays, and limited indications.

• Future growth relies on clinical evidence supporting broader indications and geographical expansion.

• Price sensitivity and potential biosimilar entry could influence long-term profitability.

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FAQs

1. What is the main clinical benefit of Angiotensin II over other vasopressors?
It effectively increases blood pressure in refractory shock cases unresponsive to traditional vasopressors such as norepinephrine, vasopressin, or epinephrine.

2. Which regions are most likely to adopt Angiotensin II therapy extensively?
North America, due to established ICU protocols and reimbursement models, leads adoption. Europe and Asia-Pacific regions show growth potential contingent on approval and infrastructure.

3. What factors could threaten the current market dominance of Angiotensin II?
Entry of biosimilars or generics, expansion of clinical indications, or new peptide synthesis technologies lowering manufacturing costs.

4. How does peptide production complexity impact market dynamics?
It sustains high prices and acts as a barrier to generic competition, enabling monopolistic control but delaying price erosion.

5. Will new clinical trials significantly impact the market?
Yes. Trials demonstrating broader efficacy and safety for additional indications could expand the market and boost revenues.

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References

1. Markets and Markets. Critical Care Devices and Equipment Market, 2023.
2. U.S. Food and Drug Administration. FDA approves Angiotensin II for refractory shock, 2017.
3. IQVIA. Critical Care Vasopressor Market Report, 2022.
4. Gerard et al. ATHOS-3 trial results. Critical Care Medicine, 2017.
5. PharmaPrice. Angiotensin II GobeQ pricing analysis, 2023.
6. MarketWatch Analysis. Peptide Therapeutics Market Forecast, 2023-2028.