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Last Updated: December 22, 2024

ISUPREL Drug Patent Profile


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When do Isuprel patents expire, and what generic alternatives are available?

Isuprel is a drug marketed by Sanofi Aventis Us and Bausch and is included in four NDAs.

The generic ingredient in ISUPREL is isoproterenol hydrochloride. There are seventeen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isoproterenol hydrochloride profile page.

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Summary for ISUPREL
US Patents:0
Applicants:2
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 118
Clinical Trials: 5
Patent Applications: 991
Drug Prices: Drug price information for ISUPREL
What excipients (inactive ingredients) are in ISUPREL?ISUPREL excipients list
DailyMed Link:ISUPREL at DailyMed
Drug patent expirations by year for ISUPREL
Drug Prices for ISUPREL

See drug prices for ISUPREL

Recent Clinical Trials for ISUPREL

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

SponsorPhase
Brain & Behavior Research FoundationN/A
University of OklahomaN/A
Vanderbilt University Medical CenterN/A

See all ISUPREL clinical trials

US Patents and Regulatory Information for ISUPREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ISUPREL isoproterenol hydrochloride AEROSOL, METERED;INHALATION 011178-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us ISUPREL isoproterenol hydrochloride SOLUTION;INHALATION 006327-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISUPREL isoproterenol hydrochloride INJECTABLE;INJECTION 010515-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ISUPREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISUPREL (Isoproterenol Hydrochloride)

Introduction to ISUPREL

ISUPREL, also known as Isoproterenol Hydrochloride, is a medication used primarily as a bronchodilator and a cardiac stimulant. It is crucial in managing conditions such as bradycardia, heart block, and respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD).

Market Drivers

The market for ISUPREL is driven by several key factors:

Increasing Prevalence of Cardiovascular and Respiratory Diseases

The rising cases of cardiovascular disorders, such as bradycardia, stroke, and heart block, along with an increase in respiratory issues like asthma and COPD, are significant drivers of the market. Cardiovascular diseases are projected to remain the leading cause of mortality worldwide, highlighting the need for effective treatments like ISUPREL[3].

Growing Geriatric Population

The global rise in the geriatric population, which is more susceptible to heart-related ailments and respiratory diseases, further amplifies the market’s potential. This demographic trend is expected to continue driving demand for ISUPREL[1].

Regulatory Support

Governments and health authorities are increasingly recognizing the importance of APIs like Isoproterenol Hydrochloride in developing effective treatment protocols. Initiatives such as the U.S. Food and Drug Administration’s (FDA) programs to expedite the review of generic drugs foster a competitive environment that benefits both manufacturers and consumers[3].

Technological Advancements and R&D

The integration of telemedicine and digital health tools is facilitating better patient access to treatments, including ISUPREL. Additionally, increasing investment in research and development, particularly in emerging economies like China, is leading to the development of new formulations and delivery methods, enhancing the market[3].

Market Segmentation

The ISUPREL market is segmented based on type and application:

By Type

  • Injection
  • Aerosol
  • Solution

These forms cater to different clinical needs and patient preferences, ensuring a broad market reach[1].

By Application

  • Bradycardia
  • Asthma
  • Heart Block
  • Other respiratory conditions

The versatility of ISUPREL in treating various medical conditions expands its market scope[1].

Regional Framework

Global Market Overview

The ISUPREL market 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 countries to provide a detailed overview of the market dynamics.

North America

North America dominates the ISUPREL market due to its robust healthcare infrastructure and significant investment in research and development. The region’s regulatory framework, which encourages pharmaceutical innovation, also plays a crucial role[3].

Asia-Pacific

The APAC region is emerging as a lucrative market, driven by increasing healthcare expenditures and a rising number of patients seeking advanced treatment options. Countries like India and China are witnessing a surge in pharmaceutical manufacturing capabilities, which is expected to facilitate the supply of ISUPREL APIs at competitive prices[3].

Market Challenges

Despite the growth drivers, the ISUPREL market faces several challenges:

Side Effects

Adequate side effects from the drug, such as tachycardia and dizziness, are expected to impede market growth. These side effects can limit the drug's adoption and usage, particularly in sensitive patient populations[1].

Price Volatility

Historical price increases, such as the nearly 2600% increase in the price of ISUPREL after Valeant Pharmaceuticals acquired it, have imposed a substantial financial burden on health systems. This volatility can affect market stability and patient access to the medication[5].

Financial Trajectory

Current Market Size and Growth Projections

The ISUPREL market is expected to witness significant growth, with a forecasted compound annual growth rate (CAGR) of around 5% by 2030. The market size is projected to increase from its current value to a substantial figure by 2031, driven by the increasing prevalence of cardiovascular and respiratory diseases, technological advancements, and regulatory support[1][3].

Revenue and Sales

Recent launches, such as Avenacy's launch of Isoproterenol Hydrochloride Injection, USP, indicate a strong market presence. For instance, ISUPREL had U.S. sales of approximately $26 million for the twelve months ending in June 2023[4].

Competitive Landscape

The market is characterized by key players focusing on organic and inorganic growth strategies. Companies are engaging in product launches, product approvals, acquisitions, and partnerships to expand their business and customer base. The competitive landscape is dynamic, with companies like Bausch Health and Avenacy playing significant roles[1][4].

Future Projections and Opportunities

Innovations in Drug Delivery Systems

Ongoing innovations in drug delivery systems, such as nebulizers and metered-dose inhalers, are expected to enhance the accessibility and usability of ISUPREL, thereby expanding its market reach[3].

Personalized Medicine

The growing trend of personalized medicine is likely to impact the ISUPREL market positively. Tailoring treatments to individual patient profiles enhances therapeutic outcomes and drives demand for APIs that can be customized[3].

Telemedicine and Digital Health

The integration of telemedicine and digital health solutions is facilitating better patient access to treatments, including ISUPREL. This trend is expected to continue, driving market growth in regions where healthcare access has traditionally been a challenge[3].

Key Takeaways

  • The ISUPREL market is driven by the increasing prevalence of cardiovascular and respiratory diseases.
  • Regulatory support and technological advancements are key factors in market growth.
  • The market faces challenges such as side effects and price volatility.
  • The financial trajectory indicates significant growth, with a projected CAGR of around 5% by 2030.
  • Innovations in drug delivery systems and personalized medicine are expected to further drive market growth.

Frequently Asked Questions (FAQs)

1. What are the primary applications of ISUPREL?

ISUPREL is primarily used to treat conditions such as bradycardia, heart block, asthma, and other respiratory diseases.

2. What are the key drivers of the ISUPREL market?

The key drivers include the increasing prevalence of cardiovascular and respiratory diseases, growing geriatric population, regulatory support, and technological advancements.

3. Which region dominates the ISUPREL market?

North America currently dominates the ISUPREL market due to its robust healthcare infrastructure and significant investment in research and development.

4. What are the potential side effects of ISUPREL?

Potential side effects include tachycardia and dizziness, which can impede market growth.

5. How is the integration of telemedicine impacting the ISUPREL market?

The integration of telemedicine and digital health solutions is facilitating better patient access to treatments, including ISUPREL, thereby driving market growth.

Cited Sources:

  1. The Insight Partners, "Isoproterenol Market Key Players Analysis 2031"
  2. Bausch Health Companies Inc., "2022 ANNUAL REPORT"
  3. PMR Market Research, "Worldwide Isoproterenol Hydrochloride API Market Research 2024"
  4. Biospace, "Avenacy Announces Launch of Isoproterenol Hydrochloride Injection, USP in the U.S. Market"
  5. Herald Open Access, "A Potential Cost Savings Strategy for Isoproterenol Hydrochloride Using Novel Stability Data"

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