Isosorbide dinitrate - Generic Drug Details

What are the generic sources for isosorbide dinitrate and what is the scope of patent protection?

Isosorbide dinitrate is the generic ingredient in four branded drugs marketed by Endo Operations, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Biovail, and Watson Labs Teva, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for isosorbide dinitrate. Twenty-two suppliers are listed for this compound.

Summary for isosorbide dinitrate

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	44
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	29
Patent Applications:	6,312
Drug Prices:	Drug price trends for isosorbide dinitrate
What excipients (inactive ingredients) are in isosorbide dinitrate?	isosorbide dinitrate excipients list
DailyMed Link:	isosorbide dinitrate at DailyMed

See drug prices for isosorbide dinitrate

Recent Clinical Trials for isosorbide dinitrate

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

Sponsor	Phase
Zealand University Hospital	Phase 4
Copenhagen University Hospital, Hvidovre	Phase 4
Johannes Grand	Phase 4

See all isosorbide dinitrate clinical trials

Pharmacology for isosorbide dinitrate

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for isosorbide dinitrate

Nitric Oxide Donors

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for isosorbide dinitrate

C01DA	Organic nitrates
C01D	VASODILATORS USED IN CARDIAC DISEASES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AE	Muscle relaxants
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

US Patents and Regulatory Information for isosorbide dinitrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086925-001	Mar 12, 1987	AB	RX	No	No
Endo Operations	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086923-001	Mar 12, 1987	AB	RX	No	No
Astrazeneca	SORBITRATE	isosorbide dinitrate	TABLET, CHEWABLE;ORAL	016776-003	Apr 1, 1996		DISCN	No	No
Hikma Intl Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	088088-001	Nov 2, 1987	AB	RX	No	No
Ani Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086032-001	Jan 7, 1988		DISCN	No	No
Zydus Lifesciences	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	213057-004	Nov 20, 2019	AB	RX	No	No

Isosorbide dinitrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isosorbide Dinitrate

Introduction

Isosorbide dinitrate, a vasodilator used primarily for the relief and prophylactic management of angina pectoris, operates within a complex market influenced by various factors. This article delves into the market dynamics, financial trajectory, and key considerations for this drug.

Market Drivers

Growing Demand for Cardiovascular Treatments

The increasing prevalence of cardiovascular diseases, such as coronary artery disease and angina pectoris, drives the demand for effective treatments like isosorbide dinitrate. As the global population ages and lifestyle factors contribute to higher rates of heart disease, the need for medications that can manage these conditions effectively is on the rise[2].

Regulatory Environment

Stringent regulations and guidelines from health authorities favor the use of established and safe medications like isosorbide dinitrate. This regulatory support helps in maintaining a stable market presence for the drug[1].

Cost-Effectiveness

Studies have shown that isosorbide dinitrate, particularly in combination with hydralazine (ISDN/HYD), can be cost-effective by reducing hospitalizations and overall healthcare costs. This cost-effectiveness is a significant driver, especially in healthcare systems looking to manage expenses while improving patient outcomes[5].

Market Restraints

High Production Costs

The manufacturing process of isosorbide dinitrate is complex and costly, which can impact its market penetration. High production costs can make the drug less competitive compared to other treatments, especially generic alternatives[1].

Competition from Generic and Alternative Treatments

The market for cardiovascular medications is highly competitive, with numerous generic and branded options available. Isosorbide dinitrate faces competition from other nitrates and newer classes of drugs, which can erode its market share[2].

Technical and Manufacturing Challenges

Technical limitations in the manufacturing process, including variability in bioavailability and extensive first-pass metabolism, can affect the drug's efficacy and patient compliance. Overcoming these challenges is crucial for maintaining market position[2].

Market Opportunities

Emerging Applications

While isosorbide dinitrate is primarily used for angina, there is potential for its use in other cardiovascular conditions. Research into new derivatives and combinations, such as ISDN/HYD, opens up opportunities for expanded applications[5].

Increasing Production Capacity

Investments in increasing production capacity can help meet the growing demand for isosorbide dinitrate. This expansion can also lead to economies of scale, potentially reducing production costs[1].

Global Market Expansion

Targeting regions with strong environmental and health regulations can be beneficial. Countries with aging populations and increasing healthcare needs offer significant market opportunities for isosorbide dinitrate[1].

Financial Trajectory

Revenue Growth

The global market for isosorbide dinitrate is expected to grow, driven by the increasing demand for cardiovascular treatments and the cost-effectiveness of the drug. Market forecasts indicate a robust growth trajectory, with the global isosorbide market projected to register a CAGR of over 8% during certain forecast periods[4].

Cost Management

Effective cost management is crucial for the financial success of isosorbide dinitrate. Strategies such as increasing the use of generics, managing utilization, and reducing hospitalizations can help in controlling costs. For instance, the ISDN/HYD combination has been shown to reduce healthcare costs by minimizing hospitalizations and improving patient outcomes[5].

Pricing Dynamics

The pricing of isosorbide dinitrate is influenced by various factors, including production costs, competition, and regulatory pressures. The drug's pricing must balance profitability with affordability to ensure market viability. The average daily drug cost of ISDN/HYD therapy, for example, is around $6.38, which is relatively affordable compared to other treatments[5].

Strategic Recommendations

Innovation and Research

Companies should focus on research and development to improve the properties and applications of isosorbide dinitrate. Innovations in new derivatives and combinations can help in capturing emerging opportunities in high-growth sectors like bioplastics and pharmaceuticals[1].

Cost-Reduction Technologies

Investing in cost-reduction technologies is essential to make isosorbide dinitrate more competitive. This includes exploring sustainable production processes and enhancing manufacturing efficiency to lower production costs[1].

Market Expansion

Targeting regions with strong environmental and health regulations can help companies capitalize on the rising demand for biodegradable and sustainable products. Fostering partnerships in the biopolymer and healthcare sectors can also enhance applications and market reach[1].

Key Company Profiles

Several companies are significant players in the isosorbide market, including BioCrick BioTech, Doc Generici SRL, Ecogreen Oleochemicals, and Merck KGaA. These companies are involved in various aspects of isosorbide production, from manufacturing to research and development. Their innovative profiles and recent developments are crucial for the market's growth and competitiveness[1].

Market Segmentation

The isosorbide market can be segmented based on product, application, and end-use. For isosorbide dinitrate, the primary application is in medical and pharmaceuticals, particularly for treating angina. Understanding these segments helps in tailoring strategies to specific market needs and opportunities[1].

Regional Analysis

The market for isosorbide dinitrate varies by region, with significant demand in the Americas, Asia-Pacific, and Europe. Regions with strong environmental regulations and aging populations offer particularly promising markets. For example, countries like the United States, China, and Japan have substantial healthcare needs that drive the demand for cardiovascular treatments[1].

Conclusion

The market dynamics for isosorbide dinitrate are shaped by a combination of factors including growing demand for cardiovascular treatments, regulatory support, and cost-effectiveness. However, the market also faces challenges such as high production costs, competition, and technical limitations. By focusing on innovation, cost reduction, and market expansion, companies can navigate these challenges and capitalize on emerging opportunities.

Key Takeaways

• Growing Demand: Increasing prevalence of cardiovascular diseases drives the demand for isosorbide dinitrate.
• Cost-Effectiveness: The drug is cost-effective, particularly in combination with hydralazine, by reducing hospitalizations and healthcare costs.
• Innovation: Research and development are crucial for improving properties and applications.
• Cost Management: Strategies to reduce production costs and manage utilization are essential.
• Market Expansion: Targeting regions with strong environmental and health regulations offers significant market opportunities.

FAQs

What is the primary use of isosorbide dinitrate?

Isosorbide dinitrate is primarily used for the relief and prophylactic management of angina pectoris in coronary artery disease.

How does isosorbide dinitrate work?

Isosorbide dinitrate works by relaxing vascular smooth muscle, leading to the dilatation of peripheral arteries and veins, which reduces left ventricular end-diastolic pressure and systemic vascular resistance[2].

What are the key market drivers for isosorbide dinitrate?

Key market drivers include the growing demand for cardiovascular treatments, regulatory support, and the cost-effectiveness of the drug.

What are the main challenges facing the isosorbide dinitrate market?

High production costs, competition from generic and alternative treatments, and technical limitations in manufacturing are significant challenges.

How can companies navigate these challenges?

Companies can navigate these challenges by focusing on innovation, cost-reduction technologies, and market expansion strategies.

Sources

1. Research and Markets: "Isosorbide Market Size, Competitors & Forecast to 2030"
2. DrugBank: "Isosorbide Dinitrate: Uses, Interactions, Mechanism of Action"
3. Law Project for Psychiatric Rights: "R E P O R T - Critical Think RxCites"
4. Mordor Intelligence: "Isosorbide Market Size | Mordor Intelligence"
5. PubMed: "Cost-effectiveness of Fixed-Dose Combination of Isosorbide Dinitrate/Hydralazine"