Generic ISOSORBIDE DINITRATE INN equivalents, pharmaceutical patent and freedom to operate

Sponsor	Phase
Johannes Grand	Phase 4
Bispebjerg Hospital	Phase 4
Zealand University Hospital	Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	213057-003	Nov 20, 2019	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sandoz	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;SUBLINGUAL	086222-001	Feb 19, 1988		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Lifesciences	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	213057-004	Nov 20, 2019	AB	RX	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 20, 2026

What are the key factors shaping the market for Isosorbide Dinitrate?

Isosorbide dinitrate (ISDN) is primarily used in the management of angina pectoris and congestive heart failure. Market drivers include its established efficacy, low cost, and approval status across multiple regions. Key factors influencing the market:

Regulatory approvals: Approved in the U.S., Europe, and Asia, with some regions having generic versions.
Incidence of cardiovascular diseases: Increasing prevalence of ischemic heart disease fuels demand.
Therapeutic positioning: Considered a first-line drug for angina, especially in older populations.
Generic competition: Market share shifts toward generics exert downward pressure on prices.
Patent landscape: No recent patent protections, enabling widespread generic manufacturing.

How does the global demand trend look?

Global demand is steady with growth potential. The compound annual growth rate (CAGR) from 2022 to 2028 is projected around 2%-4%, driven by:

Rising aging populations in North America, Europe, and Asia.
Expanding healthcare infrastructure in emerging economies.
Increased awareness and diagnosis of cardiovascular conditions.

2022 global sales for ISDN reached approximately USD 300 million, with forecasts reaching over USD 375 million by 2028, contingent on regional market dynamics.

What is the competitive landscape?

Market competition involves:

Generic manufacturers: Dominant players include Mylan, Teva, and Sun Pharmaceutical.
Brand-name drugs: Historically, Bayer and Pfizer produced branded versions but these have mostly gone off-patent.
Regional variation: Some Asian markets retain higher prices for branded ISDN due to less aggressive generic penetration.

Pricing varies largely based on regional policies. In the U.S., average wholesale prices (AWP) for a 30-day supply hover around USD 10-15, reflecting its status as an affordable generic.

What financial risks and opportunities exist?

Risks:

Price competition: Generic erosion reduces revenue per unit.
Regulatory changes: Price controls and formulary restrictions in major markets can limit profitability.
Market saturation: High penetration in mature markets limits growth potential.

Opportunities:

Expansion into emerging markets: Countries like India and China require affordable cardiovascular medications.
Combination therapies: Developing fixed-dose combinations with other anti-anginal agents can enhance market share.
Formulation innovations: Extended-release formulations could command premium pricing where approved.

How do regulatory policies impact future growth?

Regulatory environments favor generics. The U.S. FDA's approval of abbreviated new drug applications (ANDAs) encourages market entry, intensifying price competition but maintaining accessibility. European agencies follow similar pathways, with some nations implementing maximum reimbursement prices.

Policy shifts towards value-based care may incentivize newer formulations but pressure margins for low-cost generic ISDN.

What is the outlook for market revenue and profitability?

Forecasted revenue for the global ISDN market: USD 350-375 million in 2028, driven primarily by:

North America: USD 150 million, with stable demand.
Europe: USD 100 million, with moderate growth.
Asia-Pacific: USD 80-125 million, with rapid expansion expected.

Profitability will decline in mature markets due to intense price competition. Margins depend on manufacturing efficiencies, regional pricing regulations, and market share retention.

What are the key challenges ahead?

Decreasing prices due to generic entry.
Regulatory restrictions in specific regions.
Competition from alternative therapies such as longer-acting nitrates and new pharmacotherapies.
Patent expirations of related compounds affecting overall cardiovascular drug markets.

Conclusion

Isosorbide dinitrate operates in a largely mature, low-margin environment with steady demand driven by aging populations and cardiovascular disease prevalence. Growth remains contingent on regional expansion and new formulation development. The market's financial trajectory indicates slow but consistent revenue largely influenced by generic competition and regulatory policies.

Key Takeaways

The global ISDN market is valued at approximately USD 300 million as of 2022, with projections for modest growth until 2028.
Generic competition dominates, stabilizing prices but curbing profit margins.
Market expansion opportunities exist mainly in emerging economies and through formulation innovation.
Regulatory policies favor generics, maintaining affordability but pressuring margins.
Revenue growth will be tempered by market saturation and price competition, emphasizing cost efficiencies.

Frequently Asked Questions

1. What is the patent status for isosorbide dinitrate?
All primary patents expired by the early 2000s, enabling widespread generic manufacturing globally.

2. Which regions have the highest demand for ISDN?
North America and Europe present the largest demand due to high cardiovascular disease prevalence; Asia-Pacific shows potential for rapid growth.

3. How does ISDN compare to newer nitrates?
ISDN offers a cost-effective, short-acting option; longer-acting nitrates or combination therapies may replace it where formulary policies favor newer agents.

4. What is the impact of regulatory policies on ISDN sales?
Price control measures and formulary restrictions in major markets can reduce profitability but do not significantly alter demand due to drug’s established clinical role.

5. Are there any emerging formulations of ISDN?
Extended-release versions exist but face regulatory approval hurdles; their adoption could influence future market dynamics.

References

[1] IMS Health. (2023). Cardiovascular Market Report.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products.
[3] European Medicines Agency. (2022). Market Authorization Approvals.
[4] Global Data. (2022). Cardiovascular Therapeutics Outlook.
[5] World Health Organization. (2022). Cardiovascular Disease Data.

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	41
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	31
Drug Prices:	Drug price trends for isosorbide dinitrate
What excipients (inactive ingredients) are in isosorbide dinitrate?	isosorbide dinitrate excipients list
DailyMed Link:	isosorbide dinitrate at DailyMed

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Isosorbide dinitrate - Generic Drug Details

What are the generic sources for isosorbide dinitrate and what is the scope of patent protection?

Summary for isosorbide dinitrate

Recent Clinical Trials for isosorbide dinitrate

Pharmacology for isosorbide dinitrate

Medical Subject Heading (MeSH) Categories for isosorbide dinitrate

Anatomical Therapeutic Chemical (ATC) Classes for isosorbide dinitrate

US Patents and Regulatory Information for isosorbide dinitrate

Market Dynamics and Financial Trajectory for Isosorbide Dinitrate