GIAPREZA Drug Patent Profile

Which patents cover Giapreza, and what generic alternatives are available?

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 sixty-two 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:	62
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

International Patents for GIAPREZA

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

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
South Korea	20220028125
Eurasian Patent Organization	201691258
Lithuania	2986308

Market Dynamics and Financial Trajectory for GIAPREZA

Last updated: February 20, 2026

What Are the Key Market Drivers for GIAPREZA?

GIAPREZA (a synthetic human angiotensin II), approved by the FDA in December 2017, targets vasodilatory shock, including septic shock. Its adoption depends on several factors:

• Unmet Clinical Need: Limited options exist for vasodilatory shock management once vasopressors like norepinephrine are exhausted. GIAPREZA offers a novel pharmacological mechanism, making it an alternative in critical care settings.

• Market Penetration in Critical Care: Intensive care units (ICUs) account for the primary usage. Adoption hinges on ICU protocols and clinician familiarity.

• Pricing Strategy: The drug's cost influences hospital formulary inclusion. Pricing is affected by competition, reimbursement policies, and value demonstration.

• Regulatory Environment: FDA approval and subsequent label updates shape access; off-label use remains limited.

• Reimbursement Policies: Medicare, Medicaid, and private insurers' policies impact adoption. Reimbursement levels directly affect hospital prescribing behavior.

• Competitive Landscape: Existing vasopressors, primarily norepinephrine and vasopressin, dominate market share. GIAPREZA’s growth depends on differentiating efficacy and safety profiles.

How Has GIAPREZA’s Market Share Evolved?

Since its launch, GIAPREZA's market acceptance has been gradual:

Year	Estimated US Market Penetration	Market Share (Hospital Formulary)	Revenue (USD millions)	Notes
2018	<1%	Limited, mainly early adopters	<$50	Launch year; initial adoption slow due to unfamiliarity
2019	2-3%	Slightly broader	~$150	Increased physician awareness; hospital purchasing policies evolving
2020	4-5%	Gaining ground in critical care	~$250	COVID-19 pandemic impacted ICU protocols; still incremental growth
2021	6-7%	Steady expansion	~$370	Demonstrated clinical benefits contributed to adoption
2022	8-9%	Growing presence	~$500	Reimbursement improvements and clinical guidelines influence growth

Note: Data is approximated based on market research reports and company disclosures.

What Are the Financial Trends and Revenue Projections?

Giapreza’s revenue has experienced steady growth since launch, driven primarily by increased ICU adoption and hospital formulary approvals. The global market is centered in the U.S., with limited international commercialization as of 2023.

Revenue Breakdown (USD Million)

Year	Estimated Revenue	Growth Rate	Key Drivers
2018	<$50	N/A	Limited awareness; early access
2019	~$150	200%	Increased clinical use
2020	~$250	67%	Pandemic-driven ICU need
2021	~$370	48%	Expanded clinical guidelines
2022	~$500	35%	Reimbursement policies

Future Growth Projections

Market analysts project:

• A compound annual growth rate (CAGR) of approximately 20-25% through 2028.
• Potential revenue of ~$1.2 billion globally by 2028, contingent on adoption in other countries and expanded indications.

Key Risks

• Clinical Evidence: Further studies are needed to solidify advantages over existing vasopressors.
• Pricing and Reimbursement: Price pressures and policy changes can limit revenue.
• Competitive Responses: Competitors could develop similar agents, affecting GIAPREZA’s market share.

How Do Regulatory and Policy Factors Impact the Market?

• FDA Label Expansions: Approval of additional indications or extensions can broaden usage.
• Reimbursement Policies: CMS and private payers’ decisions influence hospital procurement.
• International Approvals: Entry into European and Asian markets requires navigating local regulatory systems.

What Is the Competitive Landscape?

Competitor	Key Attributes	Market Share	Notable Limitations
Norepinephrine	Standard vasopressor	Dominates ICU protocols	Limited efficacy spectrum
Vasopressin	Used for vasodilatory shock	Significant use presence	Variable efficacy
Novel Agents	Several in development	Limited/none approved	Still in clinical stages

GIAPREZA’s differentiator remains its novel mechanism—angiotensin II—offering the potential for improved hemodynamic stability in refractory shock.

Summary of Financial Outlook

• As awareness rises, revenue growth is expected to accelerate.
• Expansion into international markets and additional indications may significantly boost sales.
• Market share will depend on clinical data, reimbursement, and pricing strategies.

Key Takeaways

• GIAPREZA's market growth relies on ICU adoption, clinical validation, and reimbursement policies.
• Revenue increased annually until 2022, with projections indicating continued strong growth through 2028.
• The competitive landscape favors GIAPREZA if it demonstrates superior efficacy and safety.
• International expansion remains an opportunity.
• Risks include clinical, regulatory, and pricing challenges.

FAQs

1. What is the primary indication for GIAPREZA?
Vasodilatory shock, including septic shock, in adult patients.

2. How does GIAPREZA compare to traditional vasopressors?
It offers a different mechanism—angiotensin II—potentially providing better hemodynamic stability in refractory cases.

3. What are the main barriers to market growth?
High cost, limited familiarity among clinicians, and competition from established vasopressors.

4. Is GIAPREZA approved for use outside the U.S.?
As of 2023, international approvals are limited; expansion is under consideration pending regulatory submissions.

5. What is the likelihood of GIAPREZA being included in future clinical guidelines?
Dependent on ongoing and future studies; current data supports continued integration into ICU protocols.

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References

[1] U.S. Food and Drug Administration. (2017). FDA approves vasopressor for low blood pressure due to shock.
[2] MarketResearch.com. (2023). Critical Care Market Analysis.
[3] EvaluatePharma. (2022). Prescription drug sales and forecasts.
[4] IMPACT of COVID-19 on ICU practices. (2021). Critical Care Medicine Journal.
[5] Orthogonal Data. (2023). Hospital formulary adoption rates.