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Last Updated: December 22, 2024

ISORDIL Drug Patent Profile


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

Isordil is a drug marketed by Wyeth Ayerst, Bausch, and Biovail. and is included in three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Isordil

A generic version of ISORDIL was approved as isosorbide dinitrate by ENDO OPERATIONS on March 12th, 1987.

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Summary for ISORDIL
Drug patent expirations by year for ISORDIL
Drug Prices for ISORDIL

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Recent Clinical Trials for ISORDIL

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2
Brigham and Women's HospitalPhase 4
Momentum Research, Inc.Phase 3

See all ISORDIL clinical trials

Pharmacology for ISORDIL
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for ISORDIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst ISORDIL isosorbide dinitrate CAPSULE, EXTENDED RELEASE;ORAL 012882-002 Jul 29, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-001 Jul 29, 1988 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-002 Jul 29, 1988 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biovail ISORDIL isosorbide dinitrate TABLET;SUBLINGUAL 012940-004 Jul 29, 1988 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst ISORDIL isosorbide dinitrate TABLET, EXTENDED RELEASE;ORAL 012882-001 Jul 29, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-007 Jul 29, 1988 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-005 Jul 29, 1988 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

ISORDIL Market Analysis and Financial Projection Experimental

Isosorbide Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Isosorbide

Isosorbide, a compound derived from glucose, is widely used in various industries, including pharmaceuticals, polymers, and resins. Its applications range from treating cardiovascular diseases to serving as a component in green solvents and biodegradable plastics.

Market Size and Growth Projections

The global isosorbide market has been experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at approximately USD 0.72 million and is projected to reach USD 1.45 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.1% from 2024 to 2031[3][4].

Key Drivers of Market Growth

Increasing Demand for Sustainable Products

The shift towards more sustainable and environmentally friendly products is a major driver for the isosorbide market. Isosorbide is used in green solvents and biodegradable plastics, which are gaining popularity due to growing consumer awareness and regulatory pressures to adopt eco-friendly materials[3][4].

Pharmaceutical Industry Demand

Isosorbide derivatives, such as isosorbide mononitrate and isosorbide dinitrate, are crucial in the treatment of cardiovascular diseases, including angina and heart failure. The growing prevalence of these conditions, particularly in regions like Asia-Pacific, is driving the demand for isosorbide in the pharmaceutical sector[1][3].

Technological Advancements

Technological developments in the manufacturing process have improved the efficiency and reduced the costs associated with isosorbide production. This has increased market acceptance and driven growth in various applications[3].

Market Segmentation

By Application

The isosorbide market is segmented into various applications, including isosorbide mononitrate, isosorbide dinitrate, and isosorbide 5-mononitrate. These derivatives are used in treating cardiovascular diseases such as angina, heart failure, and hypertension[3].

By Product

The market is also segmented by product, with a focus on cardiovascular diseases, angina, heart failure, and hypertension. The pharmaceutical industry's demand for these products is a significant contributor to the market's growth[3].

By Geography

Asia-Pacific dominates the global isosorbide market, with countries like China and India leading the demand due to their large consumer bases and growing need for sustainable products[1][4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the isosorbide market. While the pandemic led to a temporary halt in construction and automotive manufacturing activities, reducing the demand for isosorbide in these sectors, it also increased the demand for isosorbide derivatives in the pharmaceutical industry. This was due to the need for treatments for chest pain (angina) induced by COVID-19[1].

Economic Value in Pharmaceutical Applications

Isosorbide dinitrate, in combination with hydralazine, is recognized for its high economic value in treating heart failure, particularly in patients who are self-identified as African American and are receiving optimal medical therapy. This combination provides significant cost-effectiveness in managing heart failure symptoms[5].

Financial Performance and Projections

Current Market Size

As of 2023, the isosorbide market was valued at USD 0.72 million, with a projected growth to USD 1.45 million by 2031[3][4].

Revenue Growth

The market is expected to grow at a CAGR of 9.1% from 2024 to 2031, driven by increasing demand from the pharmaceutical and polymer industries, as well as the growing need for sustainable products[3][4].

Regional Performance

Asia-Pacific is expected to witness the highest growth due to the increasing demand for sustainable products and the high prevalence of cardiovascular diseases in countries like China and India[1][4].

Challenges and Limitations

Health Side Effects

Despite its benefits, isosorbide derivatives can have side effects on health, which may hinder market growth. These side effects need to be carefully managed to ensure the continued adoption of isosorbide-based treatments[1].

Pandemic-Related Disruptions

The COVID-19 pandemic highlighted the vulnerability of supply chains and manufacturing processes. Future disruptions could impact the market's growth trajectory[1].

Key Takeaways

  • The isosorbide market is projected to grow significantly, driven by demand from the pharmaceutical and polymer industries.
  • The shift towards sustainable products and technological advancements are key drivers of market growth.
  • Asia-Pacific is expected to dominate the market due to high demand from countries like China and India.
  • Despite challenges, the market is poised for substantial growth, with a projected CAGR of 9.1% from 2024 to 2031.

FAQs

What are the primary applications of isosorbide?

Isosorbide is primarily used in the pharmaceutical industry for treating cardiovascular diseases such as angina and heart failure, and in the polymer industry for producing green solvents and biodegradable plastics[1][3].

How has the COVID-19 pandemic affected the isosorbide market?

The pandemic had a mixed impact, reducing demand in construction and automotive sectors but increasing demand for isosorbide derivatives in the pharmaceutical sector due to the need for treatments for COVID-19-induced angina[1].

What regions are expected to drive the growth of the isosorbide market?

Asia-Pacific, particularly countries like China and India, are expected to drive the growth of the isosorbide market due to the high demand for sustainable products and the prevalence of cardiovascular diseases[1][4].

What are the potential challenges facing the isosorbide market?

The market faces challenges such as health side effects of isosorbide derivatives and potential disruptions due to future pandemics or supply chain issues[1].

What is the projected CAGR of the isosorbide market from 2024 to 2031?

The isosorbide market is projected to grow at a CAGR of 9.1% from 2024 to 2031[3][4].

Sources

  1. Mordor Intelligence: Isosorbide Market - Share, Size & Growth.
  2. American Heart Association: 2022 AHA/ACC/HFSA Guideline for Heart Failure.
  3. Market Research Intellect: Global Isosorbide Market Size and Projections.
  4. SkyQuestT: Isosorbide Market Size & Share | Industry Growth [2030].
  5. AHA Journals: 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

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