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Last Updated: April 10, 2025

ISMO Drug Patent Profile


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Which patents cover Ismo, and what generic alternatives are available?

Ismo is a drug marketed by Promius Pharma and Alcon and is included in two NDAs.

The generic ingredient in ISMO is isosorbide. There are thirty-seven drug master file entries for this compound. Additional details are available on the isosorbide profile page.

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Summary for ISMO
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 74
Patent Applications: 4,076
DailyMed Link:ISMO at DailyMed
Drug patent expirations by year for ISMO

US Patents and Regulatory Information for ISMO

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alcon ISMOTIC isosorbide SOLUTION;ORAL 017063-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Promius Pharma ISMO isosorbide mononitrate TABLET;ORAL 019091-001 Dec 30, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Isosorbide Mononitrate (ISMN)

Overview of Isosorbide Mononitrate (ISMN)

Isosorbide mononitrate (ISMN), commonly known by brand names such as Imdur, Imdur ER, and Monoket, is an antianginal agent used to treat angina pectoris, a symptom of coronary artery disease. Here’s a detailed look at the market dynamics and financial trajectory of ISMN.

Market Size and Forecast

The ISMN market was valued at USD 400 million in 2023 and is projected to reach USD 700 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.7% during the forecast period of 2024-2030[1].

Key Drivers of Market Growth

Cardiovascular Disease Prevalence

The increasing prevalence of cardiovascular disorders worldwide is a significant driver for the ISMN market. As cardiovascular diseases rise, so does the demand for medications like ISMN[1].

Growing Aging Population

The aging population is another crucial factor. As the global population ages, the incidence of cardiovascular illnesses and related disorders increases, thereby influencing the demand for ISMN[1].

Growing Healthcare Expenditure

Increased healthcare spending in both developed and developing countries makes drugs like ISMN more accessible, contributing to market expansion[1].

Drug Delivery System Advancements

Advancements in drug delivery systems, such as extended-release formulations of ISMN, enhance patient compliance and efficacy, driving market growth[1].

Government Programs and Healthcare Policies

Government initiatives that improve access to pharmaceuticals, enhance healthcare infrastructure, and raise awareness about cardiovascular diseases also support the growth of the ISMN market[1].

Market Segmentation

By Formulation

ISMN is available in various formulations, including immediate-release and extended-release tablets. The extended-release formulations are particularly popular due to their ability to maintain therapeutic levels over a longer period, improving patient compliance[5].

By Indication

ISMN is primarily used to treat angina pectoris. Its efficacy in managing this condition makes it a staple in cardiovascular treatment regimens[5].

By Distribution Channel

  • Hospital Pharmacies: ISMN can be prescribed for both inpatient and outpatient use and is often dispensed by hospital pharmacies.
  • Retail Pharmacies/Community Pharmacies: These pharmacies fill the majority of ISMN prescriptions for outpatient use.
  • Online Pharmacies: The convenience of online pharmacies is also driving the market, especially with the growing use of e-commerce in the pharmaceutical sector[1].

By Geography

  • North America: This region holds the largest market share due to high rates of cardiovascular disease and access to advanced medical treatments.
  • Europe: The second-largest market, driven by an aging population and increased awareness of cardiovascular health.
  • Asia Pacific: Expected to grow at the highest rate due to its large population base and rapidly expanding economies.
  • Latin America and Middle East & Africa: These regions are also growing, driven by increasing healthcare spending and government initiatives[1].

Challenges and Restraints

Availability of Substitute Drugs

The presence of alternative treatments such as beta-blockers, calcium channel blockers, and surgical procedures can limit the market expansion of ISMN[1].

Drug Interactions

ISMN can have harmful interactions with other drugs, particularly those prescribed for erectile dysfunction, which may prevent its use in certain patient populations[2].

Limited Clinical Evidence

Despite its common use, there may be insufficient clinical evidence to support the effectiveness of ISMN in specific patient populations or clinical circumstances, which could impact market demand and prescribing practices[1].

Financial Trajectory

Generic Competition

The expiration of patents for branded ISMN formulations leads to the introduction of generic alternatives, which increases competition and can drive down prices, thereby increasing market penetration[1].

Pricing Dynamics

The pharmaceutical market, including ISMN, is influenced by pricing and access measures. Generic versions of ISMN can reduce costs for patients, while brand-name drugs face slower price increases due to competition and regulatory pressures[3].

Healthcare Spending Trends

Global spending on medicines is expected to grow, albeit at a slower rate than in previous years. The adoption of new medicines and the focus on value assessments will continue to shape the market. For ISMN, increased healthcare spending and the shift towards generics will be key financial drivers[3].

Patient Awareness and Emerging Markets

Increasing Patient Awareness

Greater awareness among patients about the importance of controlling cardiovascular health and the availability of therapies like ISMN can expand the market[1].

Emerging Markets

Emerging nations with rapidly urbanizing populations, changing lifestyles, and improving healthcare facilities offer significant growth opportunities for the ISMN market[1].

Technological and Clinical Developments

Technological Developments in Manufacturing Processes

Advancements in manufacturing processes could lead to more affordable production techniques, reducing the overall cost of ISMN and increasing its accessibility[1].

Clinical Studies and Research

Ongoing clinical studies and research aimed at examining the safety and efficacy of ISMN in various patient populations can expand its indications and commercial potential[1].

Key Takeaways

  • The ISMN market is projected to grow significantly, driven by increasing cardiovascular disease prevalence, an aging population, and advancements in drug delivery systems.
  • Market segmentation by formulation, indication, distribution channel, and geography highlights the diverse and growing demand for ISMN.
  • Challenges such as substitute drugs, drug interactions, and limited clinical evidence need to be addressed.
  • Financial trajectory is influenced by generic competition, pricing dynamics, and healthcare spending trends.
  • Increasing patient awareness and emerging markets offer substantial growth opportunities.

FAQs

What is Isosorbide Mononitrate (ISMN) used for?

ISMN is used to treat angina pectoris, a symptom of coronary artery disease. It is not used to treat acute angina attacks[5].

What are the common side effects of ISMN?

Common side effects include headache, dizziness, nausea, and flushing. More severe side effects can include drug interactions and specific adverse reactions such as terrifying dreams and tooth disorders[2].

How does the market segmentation of ISMN look?

The market is segmented by formulation (immediate-release and extended-release), indication (primarily angina pectoris), distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies), and geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)[1].

What are the key drivers of the ISMN market growth?

Key drivers include the increasing prevalence of cardiovascular diseases, an aging population, growing healthcare expenditure, advancements in drug delivery systems, and government programs and healthcare policies[1].

How does generic competition affect the ISMN market?

Generic competition increases market penetration by driving down prices and making ISMN more accessible to a wider range of patients[1].

What are the potential restraints on the ISMN market?

Potential restraints include the availability of substitute drugs, drug interactions, and limited clinical evidence supporting its effectiveness in specific patient populations[1].

Sources

  1. Verified Market Research: Isosorbide Mononitrate Market Size, Share, Scope & Forecast.
  2. Drugs.com: Ismo Advanced Patient Information.
  3. IQVIA: Outlook for Global Medicines through 2021.
  4. GAO: Brand-Name Prescription Drug Pricing.
  5. RxList: Ismo (Isosorbide Mononitrate): Side Effects, Uses, Dosage.

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