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Last Updated: December 23, 2024

ISOSORBIDE - Generic Drug Details


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

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

There are thirty-seven drug master file entries for isosorbide.

Drug Prices for ISOSORBIDE

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Recent Clinical Trials for ISOSORBIDE

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

SponsorPhase
Copenhagen University Hospital, HvidovrePhase 4
Johannes GrandPhase 4
Bispebjerg HospitalPhase 4

See all ISOSORBIDE clinical trials

Medical Subject Heading (MeSH) Categories for ISOSORBIDE

US Patents and Regulatory Information for ISOSORBIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075448-003 Aug 7, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598-002 Aug 11, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst ISORDIL isosorbide dinitrate TABLET, EXTENDED RELEASE;ORAL 012882-001 Jul 29, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Promius Pharma ISMO isosorbide mononitrate TABLET;ORAL 019091-001 Dec 30, 1991 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-001 Jul 29, 1988 AB RX Yes Yes ⤷  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

ISOSORBIDE Market Analysis and Financial Projection Experimental

Isosorbide Market Dynamics and Financial Trajectory

Market Overview

The global Isosorbide market is poised for significant growth, driven by increasing demand for bio-based and sustainable products. Here are the key dynamics and financial projections for the market.

Market Size and Growth Rate

  • The global Isosorbide market was valued at approximately USD 0.8 billion in 2023 and is expected to reach USD 1.9 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 9.1% during the forecast period from 2024 to 2033[2][3][4].
  • Another estimate suggests the market could reach USD 1.45 billion by 2031, also at a CAGR of 9.1% from 2024 to 2031[4].

End-Use Segments

  • The market is dominated by the resins and polymers segment, which holds a significant share, around 52.4% of the total market. This segment is driven by increasing demand from industries such as construction, electrical and electronics, and automotive[2][3].
  • Other significant end-use segments include additives and pharmaceuticals, with the latter seeing increased demand for isosorbide derivatives like isosorbide mononitrate and dinitrate for treating cardiovascular diseases[1][3].

Applications

  • Polyethylene Isosorbide Terephthalate (PEIT) leads the applications, holding a market share of around 26.3%. Other applications include polycarbonate, polyurethane, and polyester polyisosorbide succinate (PIS)[2].
  • The pharmaceutical industry is a major consumer, particularly for treating chest pain (angina) and other cardiovascular conditions[1].

Regional Analysis

  • The Asia-Pacific region dominates the global Isosorbide market, commanding a significant 32.5% share. Countries like China and India are major contributors due to their growing demand for sustainable products and the prevalence of cardiovascular diseases[2][4].
  • North America and Europe also show steady demand, driven by rigorous environmental regulations and consumer preferences for sustainable and natural products[2][3].

Driving Factors

  • The growing demand for bio-based products and sustainable materials is a key driver. Isosorbide, derived from renewable resources like corn starch and sugar beet, aligns well with the global shift towards eco-friendly products[2][3][4].
  • Increasing disposable income and wealth in developing regions, particularly in Asia and Latin America, are driving the adoption of sustainable products, including those made from isosorbide[2].

Restraining Factors

  • High initial investments required for the development and production of isosorbide are a significant barrier. Establishing bio-refining facilities and conducting research and development are costly, which can hinder market growth, especially for new entrants and smaller firms[2].
  • The COVID-19 pandemic had a negative impact on the market in 2020, particularly affecting the construction and automotive industries. However, the demand for isosorbide derivatives in the pharmaceutical sector increased during this period[1].

Impact of COVID-19

  • The pandemic temporarily halted construction and automotive manufacturing activities, reducing the consumption of isosorbide-based products. However, the pharmaceutical sector saw an increase in demand for isosorbide derivatives to treat COVID-19-related health issues[1].

Financial Projections

  • By 2033, the market is expected to reach USD 1.9 billion, with a CAGR of 9.1% from 2024 to 2033. This growth is supported by the increasing demand for sustainable materials and the expanding applications of isosorbide in various industries[2][3].
  • Another projection indicates the market could reach USD 1.45 billion by 2031, also growing at a CAGR of 9.1% from 2024 to 2031[4].

Competitive Landscape

  • The market is competitive, with key players such as J&K Scientific Ltd. and Jinan Hongbaifeng Industry. These companies are focusing on research and development to expand the applications of isosorbide and improve its production efficiency[2].

Illustrative Statistics

  • Market Size (2023): USD 0.8 billion[2]
  • Forecast Revenue (2033): USD 1.9 billion[2]
  • CAGR (2024-2033): 9.1%[2][3][4]
  • Dominant Segment: Resins & Polymers (52.4% market share)[2]
  • Leading Application: PEIT (26.3% market share)[2]
  • Regional Dominance: Asia-Pacific (32.5% market share)[2]

Expert Insights

"The increasing focus on sustainability and the growing demand for bio-based products are driving the isosorbide market. As consumers become more aware of environmental issues, the demand for eco-friendly materials is expected to rise significantly," - Industry Expert[3].

Regional Growth Opportunities

  • The rise in disposable income and accumulating wealth in developing regions, such as Asia and Latin America, presents a substantial growth opportunity. These regions are shifting towards more sustainable and environmentally friendly products, which aligns well with the benefits of isosorbide[2].

High Initial Investment Challenges

  • The high initial investments required for the development and production of isosorbide can be a significant barrier. This includes the costs associated with establishing bio-refining facilities and conducting research and development, which can be challenging for new entrants and smaller firms[2].

Key Takeaways

  • The global Isosorbide market is expected to grow significantly, driven by the demand for bio-based and sustainable products.
  • The resins and polymers segment dominates the market, with PEIT being the leading application.
  • Asia-Pacific is the leading region, driven by countries like China and India.
  • High initial investments and the impact of COVID-19 are significant challenges.
  • The market is expected to reach USD 1.9 billion by 2033, growing at a CAGR of 9.1%.

FAQs

What is the expected growth rate of the global Isosorbide market?

The global Isosorbide market is expected to grow at a CAGR of 9.1% from 2024 to 2033[2][3][4].

Which segment dominates the Isosorbide market?

The resins and polymers segment dominates the Isosorbide market, holding a 52.4% market share[2].

What are the main driving factors for the Isosorbide market?

The main driving factors include the growing demand for bio-based products, increasing focus on sustainability, and the expanding applications in various industries[2][3][4].

How did the COVID-19 pandemic impact the Isosorbide market?

The COVID-19 pandemic had a negative impact on the construction and automotive industries but increased demand for isosorbide derivatives in the pharmaceutical sector[1].

Which region commands the largest share of the global Isosorbide market?

The Asia-Pacific region commands the largest share, with a significant 32.5% of the global market[2].

Cited Sources:

  1. Mordor Intelligence: Isosorbide Market - Share, Size & Growth[1]
  2. MarketResearch.biz: Isosorbide Market Size, Share, Growth | CAGR of 9.1%[2]
  3. Grand View Research: Global Isosorbide Market Size & Share Report, 2022-2030[3]
  4. SkyQuest: Isosorbide Market Size & Share | Industry Growth [2030][4]

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