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 one branded drug marketed by La Jolla Pharma and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Angiotensin ii acetate has forty-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for ANGIOTENSIN II ACETATE

International Patents:	47
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	6
Patent Applications:	68
DailyMed Link:	ANGIOTENSIN II ACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANGIOTENSIN II ACETATE

Constraining patent/regulatory exclusivity:

10,500,247

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ANGIOTENSIN II ACETATE

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

Sponsor	Phase
Kasr El Aini Hospital	N/A
American Lung Association	Phase 2
Johns Hopkins University	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	209360-003	Dec 23, 2021		RX	Yes	Yes	9,220,745
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	10,335,451
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	9,867,863
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,572,856
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	9,867,863
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,220,745

International Patents for ANGIOTENSIN II ACETATE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201691258	АНГИОТЕНЗИН II САМОСТОЯТЕЛЬНО ИЛИ В КОМБИНАЦИИ ДЛЯ ЛЕЧЕНИЯ ГИПОТЕНЗИИ
World Intellectual Property Organization (WIPO)	2017120438
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)
Taiwan	201733610	Methods for administering angiotensin II
European Patent Office	3400000	MÉTHODES D'ADMINISTRATION D'ANGIOTENSINE II (METHODS FOR ADMINISTERING ANGIOTENSIN II)
Spain	2771749

ANGIOTENSIN II ACETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Angiotensin II Acetate

Introduction

Angiotensin II acetate, known by its brand name GIAPREZA, is a pharmaceutical agent used primarily for the treatment of refractory hypotension in adults with septic or other distributive shock. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The market for drugs like angiotensin II acetate, which are part of the broader cardiovascular therapeutic segment, is experiencing significant growth. While specific financial projections for angiotensin II acetate alone are not widely available, the overall market for cardiovascular drugs provides a context.

• The global angiotensin-converting enzyme (ACE) inhibitors market, which is closely related, is projected to reach $11,831.7 million by 2030, growing at a CAGR of 5.6% from 2023 to 2030[1].

Drivers of Market Growth

Several factors drive the growth of the market for angiotensin II acetate and similar cardiovascular drugs:

Increasing Prevalence of Cardiovascular Diseases

The escalating prevalence of cardiovascular diseases worldwide, including hypertension, heart failure, and septic shock, significantly increases the demand for effective treatments like angiotensin II acetate[1][3].

Aging Population

The global aging population contributes to the rising incidence of chronic conditions such as hypertension and heart disease, thereby increasing the demand for these drugs[3].

Advancements in Drug Formulations

Continuous research and development aimed at enhancing the efficacy and safety profiles of cardiovascular drugs, including angiotensin II acetate, propel market growth. Innovations in drug formulations and therapeutic benefits keep the market dynamic[1][3].

Government Initiatives and Awareness

Government initiatives to control and manage non-communicable diseases, including hypertension, and increasing awareness among patients and healthcare providers about the importance of managing cardiovascular health, further boost the market[3].

Opportunities

Several opportunities are emerging in the market for angiotensin II acetate:

Expanding Therapeutic Applications

Research into new applications and therapeutic benefits of angiotensin II acetate can expand its use beyond current indications, such as refractory hypotension, to other cardiovascular conditions[3].

Geographical Expansion

Markets in regions like Asia-Pacific, with large population pools and growing healthcare demands, offer significant growth opportunities. Government initiatives to promote awareness and improve healthcare infrastructure in these regions are particularly beneficial[3].

Challenges and Restraints

Despite the growth potential, the market for angiotensin II acetate faces several challenges:

Adverse Reactions and Safety Concerns

The drug is associated with adverse reactions such as thromboembolic events, transient hypertension, and peripheral ischemia. These safety concerns can impact its adoption and usage[2].

Regulatory Approvals

Stringent regulatory approvals and the need for careful monitoring and management of side effects can slow down market penetration and growth[2].

Competition from Generics

The entry of generic versions of similar cardiovascular drugs can reduce the market share and profitability of branded medications like angiotensin II acetate, leading to price erosion and revenue challenges[3].

Financial Projections

While specific financial projections for angiotensin II acetate are not detailed, the broader market context provides some insights:

• The global non-peptide drugs of angiotensin II receptor antagonist market, which includes related cardiovascular therapeutics, is expected to grow from $177,430.32 million in 2022 to $325,986.34 million by 2030, at a CAGR of 9.10% during the forecast period[3].

Regional Insights

The market for angiotensin II acetate is influenced by regional dynamics:

• North America currently dominates the market due to its strong healthcare infrastructure and the presence of major pharmaceutical players. However, the Asia-Pacific region is expected to witness significant growth due to increasing government initiatives, medical tourism, and a large population pool[3].

Key Players and Competitive Landscape

The competitive landscape for angiotensin II acetate involves key players focusing on strategic collaborations, product innovations, and geographical expansion. Companies like La Jolla Pharmaceutical Company, which developed GIAPREZA, are at the forefront of this market. Other major players in the broader cardiovascular therapeutic segment include Novartis AG, Pfizer Inc., Merck & Co., AstraZeneca, and Sanofi[1].

Recent Developments

Recent developments in the market include clinical trials and regulatory approvals. For instance, the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) study demonstrated the efficacy of GIAPREZA in treating refractory hypotension in adults with septic or other distributive shock[2].

Key Takeaways

• The market for angiotensin II acetate is driven by the increasing prevalence of cardiovascular diseases and advancements in drug formulations.
• Despite growth opportunities, the market faces challenges such as adverse reactions and competition from generics.
• Regional expansion, particularly in Asia-Pacific, offers significant growth potential.
• The financial trajectory is positive, with the broader cardiovascular therapeutic market expected to grow substantially by 2030.

Frequently Asked Questions (FAQs)

Q: What is the primary use of angiotensin II acetate? A: Angiotensin II acetate, known by its brand name GIAPREZA, is primarily used for the treatment of refractory hypotension in adults with septic or other distributive shock.

Q: What are the common adverse reactions associated with angiotensin II acetate? A: Common adverse reactions include thromboembolic events, transient hypertension, and peripheral ischemia.

Q: How is the market for angiotensin II acetate expected to grow? A: The market is expected to grow driven by the increasing prevalence of cardiovascular diseases and advancements in drug formulations, although specific financial projections for angiotensin II acetate are not detailed.

Q: Which regions are expected to see significant growth in the market for angiotensin II acetate? A: North America currently dominates, but the Asia-Pacific region is expected to witness significant growth due to increasing government initiatives and a large population pool.

Q: What are the main challenges facing the market for angiotensin II acetate? A: The main challenges include adverse reactions, stringent regulatory approvals, and competition from generic versions of similar drugs.

Sources:

1. Coherent Market Insights - Angiotensin Converting Enzymes (ACE) Inhibitors Market
2. European Commission - GIAPREZA, INN-angiotensin II acetate
3. Data Bridge Market Research - Global Non-Peptide Drugs of Angiotensin II Receptor Antagonist Market