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Last Updated: December 25, 2024

IMDUR Drug Patent Profile


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When do Imdur patents expire, and when can generic versions of Imdur launch?

Imdur is a drug marketed by Schering Plough and is included in one NDA.

The generic ingredient in IMDUR is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Imdur

A generic version of IMDUR was approved as isosorbide mononitrate by CHARTWELL MOLECULAR on October 30th, 1998.

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Summary for IMDUR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 74
Patent Applications: 4,076
DailyMed Link:IMDUR at DailyMed
Drug patent expirations by year for IMDUR

US Patents and Regulatory Information for IMDUR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering Plough IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 020225-001 Aug 12, 1993 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering Plough IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 020225-002 Aug 12, 1993 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering Plough IMDUR isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 020225-003 Mar 30, 1995 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

IMDUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for IMDUR

Introduction

IMDUR, a brand name for the drug isosorbide mononitrate, is a crucial medication in the treatment of chronic stable angina pectoris. Understanding its market dynamics and financial trajectory is essential for pharmaceutical companies, investors, and healthcare professionals.

Mechanism of Action and Clinical Use

IMDUR is an oral extended-release formulation of isosorbide mononitrate, which works by relaxing vascular smooth muscle, leading to the dilatation of peripheral arteries and veins. This action reduces the workload on the heart and increases blood and oxygen supply, effectively preventing angina attacks[1][3][5].

Market Drivers

Predominance in Healthcare

Isosorbide mononitrate, the active ingredient in IMDUR, is widely used in the treatment of angina, a common condition in patients with coronary artery disease. This widespread applicability in healthcare drives demand for the drug[4].

Growing Demand for Sustained-Release Formulations

The sustained-release formulation of IMDUR offers a convenient once-daily dosing regimen, which enhances patient compliance compared to conventional isosorbide mononitrate preparations. This convenience is a significant market driver[3].

Market Restraints

High Manufacturing Costs

The production of isosorbide mononitrate involves complex and costly processes, which can limit the profitability of the drug. High manufacturing costs are a significant restraint in the market[4].

Lack of Expertise and Patented Processes

The manufacturing process for isosorbide mononitrate is often patented and requires specialized expertise, which can restrict new entrants into the market and limit competition[4].

Market Opportunities

Emerging Applications

While primarily used for angina, research into other potential applications of isosorbide mononitrate could expand its market. Emerging applications in other end-user sectors could provide new opportunities for growth[4].

Increasing Production Capacity

As demand for isosorbide mononitrate grows, increasing production capacity can help meet this demand and potentially reduce costs through economies of scale[4].

Market Challenges

Potential Health Side Effects

Common side effects of IMDUR include headache and dizziness, which, although generally mild to moderate, can affect patient compliance. Long-term use and potential side effects are challenges that need to be addressed[1][3].

Financial Trajectory

Historical Performance

The financial performance of pharmaceutical companies that produce IMDUR or similar drugs can provide insights into the drug's market dynamics. For instance, Pfizer's financial reports show significant revenue growth in recent years, although this is more attributed to COVID-19 related products like Paxlovid and Comirnaty rather than traditional cardiovascular medications[2].

Revenue Projections

While specific revenue data for IMDUR is not readily available due to its generic status and the discontinuation of the brand name in the U.S., the overall market for cardiovascular drugs remains robust. The demand for effective treatments for chronic stable angina ensures a steady revenue stream for manufacturers of isosorbide mononitrate[4].

Competitive Landscape

Generic Competition

The discontinuation of the Imdur brand name in the U.S. and the availability of generic versions of isosorbide mononitrate have increased competition in the market. Generic competition can drive down prices but also ensures that the drug remains accessible to a wider patient population[1].

Comparative Efficacy

Studies have shown that IMDUR is as effective as or better than other sustained-release isosorbide 5-mononitrate preparations and some other antianginal medications. This comparative efficacy helps maintain its market position despite generic competition[3].

Patient Compliance and Adherence

Once-Daily Dosing

The once-daily dosing regimen of IMDUR enhances patient compliance, which is a critical factor in the long-term management of chronic stable angina. Better compliance translates to improved health outcomes and sustained market demand[3].

Regulatory Environment

Stringent Regulations

The pharmaceutical industry is heavily regulated, and any changes in regulatory requirements can impact the market dynamics of IMDUR. Compliance with these regulations is essential for maintaining market presence[4].

Consumer Behavior

Patient Preferences

Patients prefer medications with convenient dosing regimens and minimal side effects. The sustained-release formulation of IMDUR aligns with these preferences, contributing to its market stability[3].

Conclusion

IMDUR, as a treatment for chronic stable angina, operates within a complex market influenced by various factors. While it faces challenges such as high manufacturing costs and potential side effects, its sustained-release formulation, lack of tolerance development, and convenient dosing regimen maintain its market position. As the healthcare landscape evolves, ongoing research into new applications and improvements in manufacturing processes could further enhance its financial trajectory.

Key Takeaways

  • Effective Mechanism: IMDUR works by relaxing vascular smooth muscle, reducing the heart's workload and increasing blood and oxygen supply.
  • Market Drivers: Predominance in healthcare, growing demand for sustained-release formulations.
  • Market Restraints: High manufacturing costs, lack of expertise and patented processes.
  • Market Opportunities: Emerging applications, increasing production capacity.
  • Market Challenges: Potential health side effects.
  • Financial Trajectory: Steady revenue stream due to robust demand for cardiovascular treatments.
  • Competitive Landscape: Generic competition, comparative efficacy.
  • Patient Compliance: Enhanced by once-daily dosing regimen.

FAQs

What is IMDUR used for?

IMDUR is used to prevent angina (chest pain) caused by coronary artery disease. It does not relieve the pain of an angina attack that has already started[5].

How does IMDUR work?

IMDUR works by relaxing vascular smooth muscle, leading to the dilatation of peripheral arteries and veins, which reduces the heart's workload and increases blood and oxygen supply[1][3][5].

What are the common side effects of IMDUR?

Common side effects include headache and dizziness, which are generally mild to moderate and improve with long-term therapy[1][3].

Is IMDUR available in generic form?

Yes, the Imdur brand name has been discontinued in the U.S., and generic versions of isosorbide mononitrate are available[1].

How often is IMDUR taken?

IMDUR is typically taken once daily, which enhances patient compliance and maintains therapeutic efficacy throughout the day[3].

Sources

  1. Drugs.com: Imdur: Package Insert / Prescribing Information.
  2. Pfizer: PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES 2023 FINANCIAL GUIDANCE.
  3. PubMed: Isosorbide 5-mononitrate: a review of a sustained-release preparation for the treatment of chronic stable angina pectoris.
  4. ResearchAndMarkets: Isosorbide Market Size, Competitors & Forecast to 2030.
  5. Mayo Clinic: Isosorbide mononitrate (oral route).

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