ISOPROTERENOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for isoproterenol hydrochloride and what is the scope of patent protection?

Isoproterenol hydrochloride is the generic ingredient in six branded drugs marketed by 3M, Alpharma Us Pharms, Sanofi Aventis Us, Abbott, Abraxis Pharm, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Baxter Hlthcare, Cipla, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Intl Medication, Micro Labs, Nexus, Norvium Bioscience, Penn Life, Somerset Theraps Llc, Zydus Pharms, Bausch, Lilly, Armour Pharm, DEY, Parke Davis, and Fisons, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for isoproterenol hydrochloride. Twelve suppliers are listed for this compound.

Summary for ISOPROTERENOL HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	29
NDAs:	36
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	25
Patent Applications:	1,426
What excipients (inactive ingredients) are in ISOPROTERENOL HYDROCHLORIDE?	ISOPROTERENOL HYDROCHLORIDE excipients list
DailyMed Link:	ISOPROTERENOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ISOPROTERENOL HYDROCHLORIDE

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

Sponsor	Phase
University of Alberta	Phase 1
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University	Phase 4
Ningbo No. 1 Hospital	Phase 4

See all ISOPROTERENOL HYDROCHLORIDE clinical trials

Pharmacology for ISOPROTERENOL HYDROCHLORIDE

Drug Class	beta-Adrenergic Agonist
Mechanism of Action	Adrenergic beta-Agonists

US Patents and Regulatory Information for ISOPROTERENOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	217648-001	Oct 3, 2024	AP	RX	No	No
Eugia Pharma	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	211864-001	Feb 9, 2021		DISCN	No	No
Abbott	NORISODRINE AEROTROL	isoproterenol hydrochloride	DISC;INHALATION	016814-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nexus	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	206961-001	Aug 2, 2017	AP	RX	No	Yes
Cipla	ISOPROTERENOL HYDROCHLORIDE	isoproterenol hydrochloride	INJECTABLE;INJECTION	211738-001	Jun 28, 2019		DISCN	No	No
Bausch	ISUPREL	isoproterenol hydrochloride	INJECTABLE;INJECTION	010515-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

ISOPROTERENOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isoproterenol Hydrochloride

Introduction to Isoproterenol Hydrochloride

Isoproterenol hydrochloride, also known as isoprenaline, is a non-selective beta adrenoceptor agonist widely used in the treatment of cardiovascular disorders such as bradycardia, heart block, and bronchospasm during anesthesia. It is administered through various routes, including intravenous, intramuscular, and subcutaneous injections, and in emergency cases, via intracardiac injection[1].

Market Drivers

The market for isoproterenol hydrochloride is driven by several key factors:

• Rise in Cardiovascular Disorders: The increasing incidence of cardiovascular conditions like bradycardia, stroke, and heart block is a significant driver. These conditions require immediate and effective treatment, making isoproterenol hydrochloride a crucial medication[1].
• Geriatric Population Growth: The global rise in the geriatric population, which is more prone to cardiovascular and respiratory issues, further fuels the demand for isoproterenol hydrochloride[1].
• Respiratory Issues: The drug's use in treating bronchospasm, especially during anesthesia, adds to its market demand[1].

Market Restraints

Despite the strong drivers, there are several restraints that impact the market:

• Side Effects: Isoproterenol hydrochloride is associated with side effects such as tachycardia, dizziness, and dyspnea, which can impede market growth. These adverse effects necessitate careful dosage and monitoring[1].
• Price Volatility: Significant price increases, such as the 2600% hike by Valeant Pharmaceuticals in 2015, can create substantial financial burdens on health systems and affect market dynamics. This price increase from $44.50 to $1200 per ampule has led to a search for cost-saving strategies[2].

Cost Savings Strategies

To mitigate the financial impact of high prices, health institutions have been exploring cost-saving strategies:

• Extended Beyond-Use Date: Studies have shown that isoproterenol hydrochloride can be stable for up to 9 days when stored in sterile glass vials and polypropylene syringes at 5°C. This allows for the preparation of multiple doses from a single ampule, potentially reducing drug costs by up to 66%[2].
• Optimized Dosage Preparation: Preparing one 250µg isoproterenol hydrochloride intravenous admixture from a 1 mg ampule and storing unused volumes for subsequent use can significantly reduce costs. This approach facilitates multiple electrophysiology (EP) tests from a single ampule[2].

Market Segmentation

The isoproterenol hydrochloride market is segmented based on type and application:

• By Type: The market is segmented into injection, aerosol, and solution forms. The injection form is the most commonly used due to its immediate effect and ease of administration[1].
• By Application: The primary applications include treatment of bradycardia, heart block, asthma, and bronchospasm during anesthesia. Each application has specific dosage requirements and administration protocols[1].

Regional Market Analysis

The global market for isoproterenol hydrochloride is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of market trends and opportunities.

• North America: This region is a significant market due to the high prevalence of cardiovascular diseases and advanced healthcare infrastructure. Recent launches, such as Avenacy's Isoproterenol Hydrochloride Injection, USP, indicate a strong market presence[4].
• Europe and APAC: These regions also show substantial growth potential driven by increasing geriatric populations and rising healthcare expenditures[1].

Market Players and Competitive Landscape

The market for isoproterenol hydrochloride is competitive with several key players:

• Sanofi Aventis, HOSPIRA, NEXUS PHARMACEUTICALS, Amneal Pharmaceuticals, Inc, LGM Pharma, Cipla, Recipharm AB, Triveni Interchem, AMPHASTAR PHARMACEUTICALS, and Biophore are some of the prominent companies involved in the market[1].
• Avenacy: Recently launched Isoproterenol Hydrochloride Injection, USP, which is a therapeutic generic equivalent to ISUPREL®, approved by the U.S. FDA. This launch highlights the company's focus on critical injectable medications and its commitment to patient safety and streamlined patient care[4].

Financial Trajectory

The financial trajectory of the isoproterenol hydrochloride market is promising but complex:

• Market Size and Growth: The market is expected to witness high growth during the forecast period from 2024 to 2031, driven by increasing demand and the rising prevalence of cardiovascular disorders[1].
• Revenue Figures: For instance, Isoproterenol Hydrochloride Injection, USP had U.S. sales of approximately $26 million for the twelve months ending in June 2023. This indicates a stable and growing revenue stream[4].
• Cost Savings Impact: The implementation of cost-saving strategies, such as extended beyond-use dates and optimized dosage preparation, can significantly reduce healthcare costs associated with isoproterenol hydrochloride, making it more accessible and financially sustainable[2].

PEST Analysis

A comprehensive PEST (Political, Economic, Social, and Technological) analysis is crucial for understanding the broader environment affecting the isoproterenol hydrochloride market:

• Political Factors: Regulatory approvals and pricing policies significantly impact the market. For example, FDA approvals and guidelines influence the availability and pricing of isoproterenol hydrochloride[4].
• Economic Factors: Economic conditions, including healthcare budgets and reimbursement policies, affect the affordability and accessibility of the drug. The substantial price increase by Valeant Pharmaceuticals is a notable economic factor[2].
• Social Factors: The growing geriatric population and increasing awareness of cardiovascular health are social factors driving the demand for isoproterenol hydrochloride[1].
• Technological Factors: Advances in pharmaceutical manufacturing and storage technologies, such as the stability studies mentioned, can enhance the shelf life and reduce the costs associated with the drug[2].

Key Takeaways

• The isoproterenol hydrochloride market is driven by the rise in cardiovascular disorders and the growing geriatric population.
• Significant price volatility and side effects are major restraints.
• Cost-saving strategies, such as extended beyond-use dates, can reduce financial burdens.
• The market is segmented by type and application, with injections being the most common form.
• Key players are focusing on organic and inorganic growth strategies to expand their market presence.
• The financial trajectory is promising, with expected high growth during the forecast period.

FAQs

Q1: What are the primary applications of isoproterenol hydrochloride?

• Isoproterenol hydrochloride is primarily used to treat bradycardia, heart block, asthma, and bronchospasm during anesthesia[1].

Q2: How has the price of isoproterenol hydrochloride impacted the market?

• The significant price increase by Valeant Pharmaceuticals in 2015 created a substantial financial burden on health systems, leading to a search for cost-saving strategies[2].

Q3: What are the common side effects of isoproterenol hydrochloride?

• Common side effects include tachycardia, dizziness, and dyspnea[1].

Q4: How can health institutions reduce costs associated with isoproterenol hydrochloride?

• Institutions can prepare multiple doses from a single ampule and store them for up to 9 days, reducing costs by up to 66%[2].

Q5: Which regions are significant for the isoproterenol hydrochloride market?

• North America, Europe, and Asia-Pacific are significant regions due to their high prevalence of cardiovascular diseases and advanced healthcare infrastructure[1].

Sources

1. The Insight Partners - Isoproterenol Market Key Players Analysis 2031
2. Herald Open Access - A Potential Cost Savings Strategy for Isoproterenol Hydrochloride Using Novel Stability Data
3. BioSpace - Avenacy Announces Launch of Isoproterenol Hydrochloride Injection, USP in the U.S. Market
4. JAMA Network - Association of Generalized Anxiety Disorder With Autonomic Hypersensitivity During Adrenergic Stimulation (Not directly relevant but provides context on adrenergic stimulation)