Isosorbide mononitrate - Generic Drug Details

What are the generic sources for isosorbide mononitrate and what is the scope of freedom to operate?

Isosorbide mononitrate is the generic ingredient in four branded drugs marketed by Schering Plough, Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Promius Pharma, Ani Pharms, Hikma Pharms, and Omnivium Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for isosorbide mononitrate. Twenty-five suppliers are listed for this compound.

Summary for isosorbide mononitrate

US Patents:	0
Tradenames:	4
Applicants:	20
NDAs:	23
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	50
Drug Prices:	Drug price trends for isosorbide mononitrate
What excipients (inactive ingredients) are in isosorbide mononitrate?	isosorbide mononitrate excipients list
DailyMed Link:	isosorbide mononitrate at DailyMed

See drug prices for isosorbide mononitrate

See drug sales revenues for isosorbide mononitrate

Recent Clinical Trials for isosorbide mononitrate

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

Sponsor	Phase
Al-Azhar University	Early Phase 1
Cairo University	Phase 1
Aljazeera Hospital	Early Phase 1

See all isosorbide mononitrate clinical trials

Pharmacology for isosorbide mononitrate

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for isosorbide mononitrate

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

US Patents and Regulatory Information for isosorbide mononitrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	200270-001	Jun 3, 2011	AB	RX	No	No
Zydus Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	218255-003	Feb 15, 2024		DISCN	No	No
Aurobindo Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	216557-003	Nov 7, 2022	AB	RX	No	No
Actavis Elizabeth	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET;ORAL	075037-002	Oct 30, 1998	AB	RX	No	No
Strides Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	090598-001	Aug 11, 2010		DISCN	No	No

Isosorbide mononitrate Market Analysis and Financial Projection Experimental

Global Isosorbide Mononitrate Market Dynamics and Financial Trajectory

Market Overview

The global Isosorbide Mononitrate market is experiencing significant growth, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global Isosorbide Mononitrate market was valued at USD 185 million in 2023 and is forecasted to reach USD 281.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.2% during the forecast period of 2024-2030[4].

Geographic Distribution

The performance of the Isosorbide Mononitrate market varies substantially across different regions. Emerging markets, particularly in developing regions, are offering significant growth potential due to rising disposable incomes, urbanization, and a growing middle class. Companies are focusing on expanding their presence in these regions to tap into new customer bases and drive revenue growth[1].

Technological Advancements

Technological innovations, such as artificial intelligence (AI), machine learning, and big data analytics, are revolutionizing the Isosorbide Mononitrate market. These advancements enhance operational efficiencies and enable companies to offer more personalized and targeted services, which is a key driver of market growth[1].

Increasing Demand for Customization

There is a growing trend towards customization and personalization in the Isosorbide Mononitrate market. Consumers are seeking products and services tailored to their unique needs and preferences, pushing businesses to innovate and adapt to meet these demands[1].

Sustainability and Corporate Responsibility

Sustainability and corporate social responsibility (CSR) have become critical components of the Isosorbide Mononitrate market. Companies that prioritize sustainable practices and ethical governance are enhancing their brand reputation and customer loyalty, which in turn contributes to market growth[1].

Enhanced Consumer Engagement

The Isosorbide Mononitrate market is witnessing a paradigm shift in consumer engagement strategies. Businesses are leveraging digital platforms, social media, and interactive technologies to connect with their customers more effectively, leading to better customer experiences and higher satisfaction levels[1].

Key Drivers of Growth

Rising Consumer Awareness and Expectations

Today’s consumers are more informed and have higher expectations, demanding quality, transparency, and value. Businesses that can meet these expectations are likely to see increased market share and customer loyalty[1].

Economic Growth and Rising Incomes

Global economic growth and rising disposable incomes, particularly in developing regions, are driving market expansion. As consumers’ purchasing power increases, so does their ability to spend on a broader range of products and services, contributing to overall market growth[1].

Strategic Collaborations and Partnerships

Companies are forming strategic alliances and partnerships to expand their capabilities and reach. These collaborations enable businesses to leverage each other’s strengths, access new technologies, and enter new markets more effectively[1].

Market Segmentation

By Type

The Isosorbide Mononitrate market is segmented by type, including immediate-release and extended-release forms. The extended-release forms, such as those under the brand name Imdur, are particularly popular due to their convenience and sustained efficacy[2][4].

By Application

The primary application of Isosorbide Mononitrate is in the prevention and management of angina pectoris due to coronary artery disease. Its effectiveness in this area drives a significant portion of the market demand[2].

By Region

The market is segmented by region, with leading regions including North America, Europe, Asia-Pacific, and emerging markets. Each region presents unique opportunities and challenges, influenced by local healthcare policies, economic conditions, and consumer behaviors[1][4].

By Company

Key players in the Isosorbide Mononitrate market include Teva, Merck, Nesher Pharmaceuticals, Taj Pharmaceuticals, AMRI, Intas Pharmaceuticals, Sandoz, Globus Remedies, Shandong Fangming Pharmaceutical Group, and ReYoung Pharmaceutical. These companies are driving innovation and competition in the market[4].

Financial Projections

• Current Market Size: USD 185 million in 2023[4].
• Forecasted Market Size: USD 281.2 million by 2030[4].
• CAGR: 6.2% during the forecast period of 2024-2030[4].

Competitive Landscape

The competitive landscape of the Isosorbide Mononitrate market is characterized by intense competition among key players. Companies are focusing on product innovation, strategic collaborations, and expanding their presence in emerging markets to gain a competitive edge.

Consumer Behavior and Preferences

Consumers are increasingly seeking personalized healthcare solutions, which is driving the demand for customized and targeted treatments. The use of digital health technologies and personalized medicine approaches is becoming more prevalent, influencing the market dynamics of Isosorbide Mononitrate.

Regulatory Environment

The regulatory environment plays a crucial role in shaping the Isosorbide Mononitrate market. Regulatory approvals and compliance with healthcare standards are essential for market entry and expansion. Companies must navigate these regulations carefully to ensure their products meet the required safety and efficacy standards.

Pharmacological Profile

Isosorbide Mononitrate is an anti-anginal agent and vasodilator that relaxes vascular smooth muscle to prevent and manage angina pectoris. Here are some key pharmacological aspects:

• Absorption: Rapidly absorbed after oral administration, reaching peak concentrations within an hour[5].
• Metabolism: Undergoes no significant first-pass metabolism and is virtually 100% bioavailable[5].
• Elimination: The elimination half-life is approximately 5 hours, with the majority of the dose eliminated as inactive metabolites in the urine[5].

Adverse Effects and Safety

While Isosorbide Mononitrate is generally well-tolerated, it can cause several adverse effects, including:

• Vasodilatation: Leading to venous pooling, reduced cardiac output, and hypotension.
• Other Symptoms: Headache, confusion, vertigo, palpitations, visual disturbances, nausea, vomiting, syncope, and in severe cases, heart blocks, bradycardia, paralysis, coma, seizures, and death[2].

Conclusion

The Isosorbide Mononitrate market is poised for significant growth driven by technological advancements, increasing demand for customization, expansion into emerging markets, and a focus on sustainability and corporate responsibility. As the market continues to evolve, companies must adapt to changing consumer preferences, regulatory environments, and competitive landscapes to maintain their market position.

Key Takeaways

• Market Growth: The global Isosorbide Mononitrate market is expected to grow from USD 185 million in 2023 to USD 281.2 million by 2030.
• CAGR: The market will grow at a CAGR of 6.2% during the forecast period of 2024-2030.
• Key Drivers: Rising consumer awareness, economic growth, and strategic collaborations are key drivers of market growth.
• Market Segmentation: The market is segmented by type, application, region, and company.
• Pharmacological Profile: Isosorbide Mononitrate is rapidly absorbed, has a half-life of approximately 5 hours, and is eliminated primarily through the urine.

FAQs

Q1: What is the primary use of Isosorbide Mononitrate?

Isosorbide Mononitrate is primarily used for the prevention and management of angina pectoris due to coronary artery disease[2].

Q2: What is the forecasted market size of Isosorbide Mononitrate by 2030?

The global Isosorbide Mononitrate market is forecasted to reach USD 281.2 million by 2030[4].

Q3: What are the key drivers of growth in the Isosorbide Mononitrate market?

Key drivers include rising consumer awareness and expectations, economic growth and rising incomes, and strategic collaborations and partnerships[1].

Q4: How is Isosorbide Mononitrate absorbed and eliminated in the body?

Isosorbide Mononitrate is rapidly absorbed after oral administration, reaches peak concentrations within an hour, and is eliminated primarily through the urine as inactive metabolites[5].

Q5: What are some common adverse effects of Isosorbide Mononitrate?

Common adverse effects include vasodilatation, headache, confusion, vertigo, palpitations, visual disturbances, nausea, vomiting, and in severe cases, heart blocks, bradycardia, paralysis, coma, seizures, and death[2].

Sources

1. Global Isosorbide Mononitrate Market [2024-2032] | Streamline Business Operations - Northeast News Channel Nebraska
2. Isosorbide mononitrate: Uses, Interactions, Mechanism of Action - DrugBank
3. Global Isosorbide Mononitrate Tablet Market Size, Trends and ... - Market Research Intellect
4. Isosorbide Mononitrate - Market Size - Valuates Reports - Valuates Reports
5. Pharmacokinetics of isosorbide mononitrate - PubMed - PubMed