ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Drug Patent Profile

When do Isosorbide Dinitrate And Hydralazine Hydrochloride patents expire, and what generic alternatives are available?

Isosorbide Dinitrate And Hydralazine Hydrochloride is a drug marketed by I3 Pharms and Novast Labs and is included in two NDAs.

The generic ingredient in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.

Summary for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	7
What excipients (inactive ingredients) are in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE?	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE excipients list
DailyMed Link:	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

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

Sponsor	Phase
The Danish Regions: Foundation for Medical Research	Phase 4
Danish Council for Independent Research	Phase 4
Henrik Wiggers	Phase 4

See all ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE clinical trials

Pharmacology for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Drug Class	Arteriolar Vasodilator Nitrate Vasodilator
Physiological Effect	Arteriolar Vasodilation Vasodilation

US Patents and Regulatory Information for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988-001	Jan 17, 2024	AB	RX	No	No
Novast Labs	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586-001	Apr 6, 2022	AB	RX	No	No

Market Dynamics and Financial Trajectory for Isosorbide Dinitrate and Hydralazine Hydrochloride

Last updated: February 13, 2026

Market Overview
Isosorbide dinitrate combined with hydralazine hydrochloride targets a specific segment within cardiovascular therapies, primarily chronic heart failure. The combination formulation is marketed under brand names such as BiDil in the United States, approved specifically for African American populations with heart failure. The drug’s niche status impacts its market size and growth prospects.

Regulatory and Patent Landscape
BiDil received FDA approval in 2005 for heart failure in self-identified African Americans. This makes it unique, as it was one of the first drugs approved explicitly for a racial subgroup. Patent protection lasted until around 2017, with exclusivity agreements ending; current market entry faces generic competition. As a generic, the drug has defined pricing pressures and limited exclusivity driving revenue.

Market Size and Growth Trends
Global sales of bi-dil-like combinations are modest. US sales were approximately $10 million annually in recent years, with some variation influenced by patient access and prescribing patterns. In 2021, the U.S. market experienced stabilization, with limited growth prospects owing to the aging male population with hypertension and heart failure.

Key Drivers of Market Demand

• Targeted Population: The drug’s prescription is concentrated mainly among African American patients, comprising roughly 13-15% of the U.S. heart failure population [1].
• Clinical Guidelines: The drug's recommendation in specific heart failure cases influences prescribing patterns, but newer drugs with broader indications or simplified regimens impact demand.
• Generic Competition: Entry of generics reduces prices but can expand access, balancing revenue decline per unit against increased volume.

Market Challenges

• Limited Indications: Approved solely for heart failure in African American patients constrains market size.
• Competitive Alternatives: Other vasodilator therapies and the emergence of new heart failure medications like SGLT2 inhibitors diminish market share.
• Cost-effectiveness: Rising healthcare costs favor newer, more effective therapies, pressuring older drugs like Isosorbide Dinitrate and Hydralazine Hydrochloride.

Financial Trajectory and Forecasts

• Analyst Projections: Future revenues are expected to decline gradually due to generic competition and limited expansion.
• Potential for Reformulation or New Indications: No significant pipeline products suggest limited upside unless new formulations or indications are developed.
• Market Penetration: Incremental growth is unlikely; the current market could diminish by 5-10% annually without strategic repositioning.

Opportunities and Risks

• New indications could theoretically expand revenue but require extensive clinical trials.
• Diversification into combination therapies designed for broader patient populations might uplift the market.
• Conversely, policy changes favoring cost-effective medicines and newer therapies pose risks of obsolescence.

Summary
The market for Isosorbide Dinitrate and Hydralazine Hydrochloride is small, stable to declining, with limited growth prospects driven by generic competition and narrow indications. Financial performance is forecasted to decline in the medium term unless innovation or label expansion occurs.

---

Key Takeaways

• Approved primarily for African American patients with heart failure, limiting market size.
• Market revenues are around $10 million annually in the US with downward trends expected.
• Generic competition erodes pricing power, constraining profit margins.
• Growth prospects are weak unless new indications or formulations are developed.
• Shifts toward newer therapies for heart failure could further diminish the drug’s market relevance.

---

FAQs

1. Why is the drug marketed mainly for African American patients?
The FDA approved BiDil specifically for self-identified African Americans based on clinical trials indicating increased efficacy within this population, addressing a unique disparity in heart failure treatment.

2. How does generic entry affect the drug's revenue?
Generic competition significantly lowers prices and reduces market share, leading to a decline in revenues from the branded formulation.

3. Are there ongoing developments to expand the drug’s use?
No active late-stage clinical trials suggest plans for label expansion; the focus remains on the existing population segment.

4. What are the competitive alternatives?
Other vasodilators, beta-blockers, ACE inhibitors, and emerging drugs like SGLT2 inhibitors provide broader or alternative treatment options for heart failure patients.

5. Is there potential for reformulation or combination therapies?
No public plans for reformulation; any new combination or indication would require substantial investments in clinical trials and regulatory approval.

---

References

[1] American Heart Association. Heart Failure Data, 2021.