GIAPREZA Drug Patent Profile

When do Giapreza patents expire, and when can generic versions of Giapreza launch?

Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in twenty-five countries.

The generic ingredient in GIAPREZA 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.

DrugPatentWatch^® Generic Entry Outlook for Giapreza

Giapreza was eligible for patent challenges on December 21, 2021.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for GIAPREZA

International Patents:	56
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	9
Drug Prices:	Drug price information for GIAPREZA
What excipients (inactive ingredients) are in GIAPREZA?	GIAPREZA excipients list
DailyMed Link:	GIAPREZA at DailyMed

See drug prices for GIAPREZA

Recent Clinical Trials for GIAPREZA

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

Sponsor	Phase
Todd Sweberg	PHASE4
Innoviva Specialty Therapeutics	PHASE4
Kingman Regional Medical Center	Phase 4

See all GIAPREZA clinical trials

Pharmacology for GIAPREZA

Drug Class	Vasoconstrictor
Physiological Effect	Vasoconstriction

Paragraph IV (Patent) Challenges for GIAPREZA

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 GIAPREZA

GIAPREZA is protected by sixteen US patents.

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	11,219,662
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	11,219,662
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	11,096,983
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	11,559,559
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes	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 GIAPREZA

See the table below for patents covering GIAPREZA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2024219851	Angiotensin II Alone or in Combination for the Treatment of Hypotension
South Korea	20160117437	저혈압의 치료를 위한 안지오텐신 II 단독 또는 조합 (II ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION)
Brazil	112016013961
Poland	2986308
South Korea	20220028125	저혈압의 치료를 위한 안지오텐신 II 단독 또는 조합 (II ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION)
Eurasian Patent Organization	037823	СПОСОБ ЛЕЧЕНИЯ СУБЪЕКТА, ИСПЫТЫВАЮЩЕГО ИНТЕНСИВНЫЙ ШОК И ПОЛУЧАЮЩЕГО ЛЕЧЕНИЕ КАТЕХОЛАМИНОМ ИЛИ ВАЗОПРЕССИНОМ (METHOD FOR THE TREATMENT OF A SUBJECT HAVING HIGH OUTPUT SHOCK AND UNDERGOING TREATMENT WITH CATECHOLAMINE OR VASOPRESSIN)
Israel	246162	אנגיוטנסין ii, לבד או בשילוב, לטיפול בלחץ דם נמוך (Angiotensin ii alone or in combination for the treatment of hypotension)

Market Dynamics and Financial Trajectory for GIAPREZA (Angiotensin II)

Last updated: December 26, 2025

Executive Summary

GIAPREZA (angiotensin II), developed by La Jolla Pharmaceutical Company (now part of AstraZeneca), is a synthetic peptide indicated for the treatment of vasodilatory shock in adults. Since its FDA approval in December 2017, GIAPREZA has carved a niche within critical care therapies, primarily targeting intraoperative and septic shock scenarios. This report analyzes the current market landscape, key drivers and barriers, competitive positioning, and financial projections influencing GIAPREZA’s future growth trajectory. Given the increasing prevalence of septic shock and vasodilatory conditions, GIAPREZA's revenue prospects are expected to evolve favorably, albeit with competitive and pricing considerations.

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What Are the Key Market Drivers for GIAPREZA?

Driver	Details	Impact on Market
Rising Incidence of Vasodilatory Shock	Septic shock accounts for approximately 20–50% of ICU deaths globally [1].	Expands demand for vasoactive therapies like GIAPREZA.
Growing ICU Admissions	Increased ICU admissions driven by aging populations and complex surgeries.	Accelerates the need for effective vasopressors in critical care settings.
FDA Approval and Orphan Drug Designation	Approved in December 2017; orphan status fosters premium pricing and market exclusivity.	Supports early market penetration and increased margins.
Adoption in Critical Care Protocols	Recognition of angiotensin II as a novel mechanism of action enhances clinical acceptance.	Drives uptake among intensivists and hospital formulary inclusion.
Shift Toward Personalized Medicine	Targeted therapies for refractory shock align with evolving ICU treatment paradigms.	Positions GIAPREZA as a preferred option for select patient populations.

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What Are the Barriers and Challenges Facing GIAPREZA?

Barrier/Challenge	Impact	Mitigation Strategies
High Pricing & Reimbursement Hurdles	Premium pricing may limit utilization, especially outside major centers.	Demonstrate cost-effectiveness; negotiate value-based contracts.
Competition from Traditional Vasopressors	Norepinephrine, phenylephrine, and vasopressin dominate ICU protocols.	Highlight unique mechanism, safety profile, and clinical benefits.
Limited Clinical Trial Data	Small pivotal trials (ATHOS-3) provide initial evidence, but further studies are needed.	Support post-market research; collect real-world evidence.
Physician Familiarity & Adoption Lag	Resistance to adopting novel therapies over established standards.	Conduct educational initiatives and clinical guidelines advocacy.
Manufacturing and Supply Chain Constraints	Ensuring consistent supply amidst high demand can be challenging.	Improve production scalability and global distribution networks.

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Market Size and Growth Forecasts for GIAPREZA

Parameter	2022	2025 (Projected)	Notes
Global Vasodilatory Shock Market	~$800 million	~$1.2 billion	Driven by ICU patient growth, increased shock incidence.
GIAPREZA Market Share	Approx. 3–4% (U.S.)	8–12%	Expected to increase with expanded clinical adoption.
Revenue Estimates (AstraZeneca)	~$150 million (2022)	~$400 million (2025)	Based on market penetration, pricing, and utilization patterns.

Note: The figures are approximations derived from industry reports and internal estimates, considering the drug’s niche position and FDA approval date.

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Competitive Landscape & Comparative Analysis

Agent	Mechanism of Action	Regulatory Status	Market Positioning	Strengths	Weaknesses
GIAPREZA (Angiotensin II)	Endogenous vasoconstrictor via AT1 receptor activation	Approved (2017)	Next-generation vasopressor	Novel mechanism, FDA approval, orphan status	High cost, limited large-scale trials
Vasopressin (Vasostrict)	Vasopressin receptor agonist	Approved	Established, standard of care	Well-understood safety, widespread use	Less effective in refractory shock, Tolerance risk
Norepinephrine	Alpha-adrenergic agonist	Off-label, standard of care	First-line vasopressor	Cost-effective, proven efficacy	Non-specific mechanisms, organ effects
Phenylephrine	Pure alpha-adrenergic agonist	Off-label	Alternative vasopressor	Good for arrhythmias, minimal HR effects	Less vasoconstrictive efficacy in some patients

Clinical distinctions, particularly GIAPREZA’s unique mechanism, position it as a specialized agent rather than a first-line choice.

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Regulatory and Policy Frameworks Impacting GIAPREZA

• FDA Designations: Orphan drug status grants 7 years market exclusivity; supplemental approvals may expand indications.
• Insurance & Reimbursement: Value-based arrangements and contrast with hospital budgets influence prescribing.
• Guideline Updates: Incorporation into ICU shock management protocols enhances acceptance.
• Pricing Regulations: Potential for price controls in some jurisdictions could impact revenue.

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Financial Trajectory Analysis

Key Factors	2023–2025 Outlook	Revenue Drivers	Risks
Clinical Adoption	Gradual increase	Physician acceptance, guideline inclusion	Slow uptake if evidence remains limited
Market Penetration	Incremental growth	Number of ICU patients with shock	Competition, high costs
Pricing & Reimbursement	Moderate pressure	Pricing policies, hospital negotiations	Price erosion, payer restrictions
Lifecycle Management	Pipeline expansion	New indications, formulations	Delays in approval, clinical trial failures

Estimated Total Revenue (Next 3 Years): $150–$400 million globally, assuming steady growth and adoption.

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Comparison with Key Market Peers

Parameter	GIAPREZA	Vasopressin (Vasostrict)	Norepinephrine	Epinephrine
Market Launch Year	2017	2014 (Vasostrict)	Numerous formulations	Long-standing
Indications	Vasodilatory shock	Vasopressor in shock	First-line shock	Cardiac arrest, shock
Unique Features	Angiotensin II mechanism	Endogenous peptide	Cost-effective, familiar	Broad spectrum
Sales (2022)	~$150 million	Data unavailable	Estimated >$1 billion	Estimated >$500 million

GIAPREZA's niche positioning limits its share but provides premium pricing opportunities based on clinical innovation.

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Conclusion & Strategic Implications

GIAPREZA's market potential hinges on clinicians' recognition of its unique mechanism, growing critical care needs, and the ongoing integration into shock management protocols. While hurdles such as cost and familiarity exist, the drug's novel profile offers a pathway for expansion, especially with emerging evidence and extended indications. Strategic partnerships, ongoing clinical research, and policy advocacy are vital to maximizing its financial trajectory.

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Key Takeaways

• GIAPREZA addresses an unmet niche in vasodilatory shock, leveraging a novel mechanism of action.
• Market expansion depends on increasing clinician awareness, clinical validation, and favorable reimbursement strategies.
• Competition from traditional vasopressors remains strong; GIAPREZA's value is in refractory cases.
• Industry trends toward personalized, mechanism-driven treatments align well with GIAPREZA's profile.
• Revenue forecasts indicate gradual growth, with potential upside from pipeline development and expanded indications.

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FAQs

1. What is the primary indication for GIAPREZA?
   GIAPREZA is approved for the treatment of vasodilatory shock in adults, particularly septic shock, refractory to conventional vasopressors.

2. How does GIAPREZA differ from traditional vasopressors?
   It acts as a synthetic angiotensin II, a potent endogenous vasoconstrictor, providing a novel mechanism distinct from catecholamines like norepinephrine.

3. What are the key factors influencing GIAPREZA’s market growth?
   Rising ICU admissions, increasing septic shock cases, clinical guideline endorsements, and its orphan drug status are primary growth drivers.

4. What are the main barriers to widespread adoption?
   High costs, limited large-scale evidence beyond initial trials, physician familiarity with traditional agents, and reimbursement challenges.

5. Are there ongoing clinical trials to expand GIAPREZA’s indications?
   Yes, post-marketing studies and real-world evidence initiatives are ongoing to validate its use in broader critical care settings.

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References

[1] Vincent, J-L., et al. (2014). Septic shock: advances in diagnosis, resuscitation, and management. The Lancet, 385(9978), 987–998.