Last Updated: June 17, 2026

isosorbide - Profile


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What are the generic drug 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, Ph Health, 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 Intl, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Promius Pharma, Genus, Hikma Pharms, and Omnivium Pharms, and is included in sixty-five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for isosorbide
US Patents:0
Tradenames:9
Applicants:37
NDAs:65

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
Alcon ISMOTIC isosorbide SOLUTION;ORAL 017063-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations DILATRATE-SR isosorbide dinitrate CAPSULE, EXTENDED RELEASE;ORAL 019790-001 Sep 2, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst ISORDIL isosorbide dinitrate CAPSULE, EXTENDED RELEASE;ORAL 012882-002 Jul 29, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Astrazeneca SORBITRATE isosorbide dinitrate TABLET, CHEWABLE;ORAL 016776-002 Apr 1, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 17, 2026

What Is the Investment Outlook for Isosorbide?

Isosorbide is a small molecule primarily used as a vasodilator and a precursor in producing biodegradable polymers. Its market is driven by applications in pharmaceuticals and plastics. The compound has a well-established patent life, with limited but consistent demand growth. Current trends indicate stable pricing and modest volume growth, with potential expansion in certain niche markets such as medical devices and biodegradable plastics.

What Are the Market Drivers for Isosorbide?

Pharmaceutical Demand

Isosorbide is used as an active pharmaceutical ingredient (API) in formulations for managing angina and heart failure. It is a component in isosorbide dinitrate and mononitrate. Demand from cardiovascular drug markets remains stable, with global sales touching approximately $300 million in 2022, according to industry data[1].

Green Chemistry and Bioplastics

Increasing focus on sustainable materials promotes use of isosorbide as a monomer in bio-based polymers like polyisosorbide terephthalate (PIT), which competes with petroleum-based plastics. The bioplastics segment is expected to grow at a compound annual growth rate (CAGR) of 10-12% through 2030, with isosorbide-based polymers representing a growing niche[2].

Regulatory Environment

Market growth benefits from regulatory approvals favoring biodegradable and non-toxic materials. As regulators tighten restrictions on single-use plastics, demand for bio-based alternatives like isosorbide-derived polymers could increase.

What Are the Key Supply and Manufacturing Considerations?

Production Technologies

Isosorbide is produced via dehydration of sorbitol, derived from glucose or sucrose. Major producers include India, China, and Europe. Production capacity is concentrated, with significant expansion potential if bioplastics markets accelerate.

Price Trends and Cost Dynamics

Prices for isosorbide have ranged from $4 to $7 per kg over the past five years. Raw material costs, especially sorbitol, influence pricing. Technological advancements may enable cost reductions by increasing yield and process efficiency.

Supply Risks

Supply chain disruptions could emerge from raw material shortages or geopolitical issues. Market concentration among a few producers adds some vulnerability, though substitute monomers exist in niche applications.

What Are the Competitive and Regulatory Challenges?

Competition in Pharmaceuticals

While the pharmaceutical market for isosorbide-based treatments is mature, patent expiration and generic competition pressure prices downward. R&D efforts focus on new delivery mechanisms and combination drugs to extend product life cycles.

Competition in Bioplastics

Isosorbide faces competition from other monomers like bisphenol A (BPA) and bio-derived alternatives such as succinic acid. The relative cost competitiveness and process scalability will influence market share.

Regulatory Environment

Stringent regulations on plastics and pharmaceuticals will impact manufacturing and usage. Compliance with environmental standards and drug safety regulations requires ongoing investment.

What Are the Future Growth Opportunities?

  • Niche Pharmaceuticals: Developing new formulations or delivery mechanisms for aging populations or emerging markets.
  • Biodegradable Plastics: Scaling production and reducing costs for bio-based polymers to challenge petrochemical plastics.
  • New Derivatives: Synthesizing novel derivatives with enhanced properties for medical or industrial applications.

What Is the Investment Risk Profile?

Market Maturity and Price Stability

The pharmaceutical segment for isosorbide remains mature, with stable but limited growth. Price pressures from generics and commoditization hinder significant profit expansion.

Technological Risks

Advancements could render existing production methods obsolete, but current technologies are well-established.

Regulatory Risks

Stringent and evolving regulations could restrict certain uses or increase compliance costs, especially in environmentally sensitive applications.

Market Concentration

Limited supplier diversity entails supply risks. Investment in capacity expansion could mitigate this but requires significant capital.

What Is the Overall Investment Thesis?

Investors should view isosorbide as a stable, low-growth asset in the pharmaceutical segment, with additional growth potential in bioplastic applications. Market demand remains grounded in existing workflows, but technological and regulatory developments could alter risk/reward dynamics.

Key Takeaways

  • Isosorbide is a bio-based, versatile compound used in pharmaceuticals and bioplastics.
  • Demand in pharmaceuticals remains stable; bioplastics present growth opportunities.
  • Supply chains are concentrated; raw material costs influence pricing.
  • Competition and regulation pose risks; technological innovation can open new pathways.
  • Investment prospects depend on growth in bioplastics and emergence of new pharmaceutical applications.

FAQs

1. What are the main applications of isosorbide?
Primarily used as an API in cardiovascular drugs and as a monomer in biodegradable plastics.

2. How does technology influence isosorbide production?
Advances in dehydration and catalytic processes improve yield and reduce costs, impacting supply availability and pricing.

3. Who are the leading producers of isosorbide?
Major producers include India’s SLO and China’s Huzhou Huaze Technology, with European companies like Ripplon Chemicals engaged in custom synthesis.

4. What are regulatory challenges associated with isosorbide?
Increased regulation of plastics reinforces demand for biodegradable polymers but may constrain certain pharmaceutical formulations under evolving safety standards.

5. How does the market competition impact isosorbide pricing?
Market concentration and patent expiries in pharmaceuticals pressure margins; bioplastics competition influences monomer prices and market share.


Citations

[1] Pharmaceutical Market Data, IQVIA, 2022.
[2] MarketResearch.com, "Growth of Bioplastics," 2023.

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