ISOSORBIDE - Generic Drug Details

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, 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.

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

Summary for ISOSORBIDE

US Patents:	0
Tradenames:	9
Applicants:	37
NDAs:	65
Drug Master File Entries:	37
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	78
Drug Prices:	Drug price trends for ISOSORBIDE
DailyMed Link:	ISOSORBIDE at DailyMed

See drug prices for ISOSORBIDE

Recent Clinical Trials for ISOSORBIDE

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

Sponsor	Phase
Shenzhen Second People's Hospital	PHASE3
Beijing Tiantan Hospital	PHASE3
Ruijin Hospital	PHASE4

See all ISOSORBIDE clinical trials

Medical Subject Heading (MeSH) Categories for ISOSORBIDE

Diuretics, Osmotic

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
Impax Labs Inc	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET, EXTENDED RELEASE;ORAL	040723-001	Mar 17, 2008		DISCN	No	No
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-006	Jul 29, 1988		DISCN	Yes	No
Aurobindo Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	216557-003	Nov 7, 2022	AB	RX	No	No
Ani Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET;ORAL	075147-002	Mar 27, 2026	AB	RX	No	No
Rubicon	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	215723-005	Jul 8, 2022	AB	RX	No	No
Ph Health	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086923-001	Mar 12, 1987	AB	RX	No	No

Market Dynamics and Financial Trajectory for Isosorbide

Last updated: February 15, 2026

Overview

Isosorbide is a chemical compound used primarily in two clinical applications: as an active pharmaceutical ingredient (API) for treating angina pectoris and as a precursor in manufacturing polycarbonate plastics. Its pharmaceutical use centers on its role as a nitrate vasodilator to prevent anginal attacks. The market for isosorbide-based drugs is influenced by factors including aging populations, cardiovascular disease prevalence, FDA approvals, generic entry, and manufacturing trends.

Market Size and Growth Trends

The global pharmaceutical market for isosorbide-based products, primarily extended-release formulations like isosorbide mononitrate, was valued at approximately USD 400 million in 2021. The compound's key application in oral nitrates benefits from a steady growth trajectory driven by the increasing burden of ischemic heart disease globally.

Projections estimate an annual growth rate of around 3-5% over the next five years, reaching USD 520-610 million by 2026. This growth outlook considers factors such as rising cardiovascular disease prevalence, patent expiries of branded formulations, and the expansion in developing markets.

Market Drivers

1. Aging Populations and Cardiovascular Disease (CVD) Trends

   Growth in the elderly demographic corresponds with increased incidence of hypertension and angina, boosting demand for nitrates like isosorbide mononitrate.

2. Patent Expiry and Generic Competition

   Several patents for leading formulations expired between 2018 and 2021, leading to increased generic entry, reducing prices and expanding access, particularly in emerging markets.

3. Regulatory Approvals and Off-Label Uses

   The FDA and EMA approvals of modified-release formulations facilitate broader prescriber adoption. Emerging off-label uses, such as in pulmonary hypertension, may influence future demand.

4. Manufacturing Trends

   Production costs for isosorbide are relatively stable; however, raw material prices and supply chain disruptions impact gross margins. The move toward biosimilars is minimal, but generics dominate the market.

Market Challenges

• Competitive Landscape

  Established pharmaceutical companies, including Teva Pharmaceuticals, Mylan, Dr. Reddy’s Labs, and Lupin, lead generic production. Competition results in price erosion, constraining profit margins.

• Clinical Limitations

  Isosorbide has known side effects, such as hypotension and headache, which may limit its prescribing scope relative to newer therapies for ischemic heart disease.

• Supply Chain and Raw Material Dependence

  Raw materials derived from glycerol, a byproduct of biodiesel production, have fluctuating prices. Supply disruptions could impact manufacturing stability.

Financial Trajectory

• Revenue Growth

  With a compound annual growth rate (CAGR) of approximately 4%, revenues are projected to increase from USD 400 million in 2021 to USD 520-610 million in 2026.

• Profitability

  The entry of low-cost generics compresses profit margins for market incumbents, with typical gross margins around 50% for branded formulations declining towards 30-40% for commoditized generics.

• Research and Development (R&D) Investment

  R&D investment focuses on new delivery mechanisms, combination therapies, and potential novel indications. R&D expenditure accounts for about 5-10% of revenues for major players.

• Future Opportunities

  Development of combination therapies with other cardiovascular agents and exploring new delivery routes could enhance market share and profitability.

Policy and Regulatory Impact

Pending patent challenges and the potential for regulatory reforms in different jurisdictions influence market stability. Some governments are expanding access policies for generic drugs, further accelerating volume sales.

Summary

The isosorbide market exhibits stable, moderate growth driven by demographic and epidemiological trends. Pricing pressures from generics and market entry barriers limit revenue expansion. Ongoing innovation and geographical expansion potential can sustain future revenue growth.

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Key Takeaways

• The global market for isosorbide-based products is valued at approximately USD 400 million (2021), with a projected growth to USD 520-610 million (2026).
• Key growth factors include aging populations, increased CVD burden, and patent expiries leading to generic competition.
• Price competition constrains profit margins, especially in mature markets.
• Innovation in delivery and indications offers new revenue streams for pharmaceutical companies.
• Market entrants must navigate raw material supply fluctuations and regulatory changes impacting product access.

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FAQs

1. What main factors affect isosorbide market growth?
   Demographic trends, CVD prevalence, patent expiries, and regulatory approval statuses.

2. How does generic competition influence profitability?
   It drives prices downward, reducing gross margins but expanding consumption volume.

3. Are there emerging applications for isosorbide?
   Potential emerging uses include pulmonary hypertension treatment and polymer manufacturing, but these are in early development stages.

4. What risks could impact future revenue?
   Supply chain disruptions, regulatory shifts, and competition from newer therapeutics.

5. What are the key regions driving growth?
   North America, Europe, and emerging markets in Asia-Pacific are the primary regions with increasing demand.

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Sources

[1] IBISWorld, "Isosorbide Market Report," 2022.
[2] GlobalData, "Pharmaceuticals and Cardiology Trends," 2022.
[3] US FDA, “Approved Nitrates and Therapeutic Indications,” 2022.