HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - Generic Drug Details

What are the generic drug sources for hydralazine hydrochloride; isosorbide dinitrate and what is the scope of freedom to operate?

Hydralazine hydrochloride; isosorbide dinitrate is the generic ingredient in two branded drugs marketed by Azurity, I3 Pharms, and Novast Labs, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	6
Clinical Trials:	7
DailyMed Link:	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE at DailyMed

Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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 HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE clinical trials

Pharmacology for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Drug Class	Arteriolar Vasodilator Nitrate Vasodilator
Physiological Effect	Arteriolar Vasodilation Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

C01DA	Organic nitrates
C01D	VASODILATORS USED IN CARDIAC DISEASES
C01	CARDIAC THERAPY
C	Cardiovascular system

C02DB	Hydrazinophthalazine derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

C05AE	Muscle relaxants
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	AB	RX	Yes	Yes
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

Expired US Patents for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Hydralazine Hydrochloride and Isosorbide Dinitrate?

Hydralazine hydrochloride and isosorbide dinitrate are combined therapies primarily used in managing heart failure, particularly in African-American populations. The combination is marketed under the brand name Bidil. The market for these drugs is influenced by demographic trends, regulatory approvals, and clinical guidelines.

Market Penetration and Geographic Focus

• The U.S. represents the primary market, driven by the FDA's approval of Bidil in 2005 as a treatment for heart failure in African-Americans.
• The patent for Bidil expired in 2017, exposing the drug to generic competition, which impacts pricing and market share.
• Expansion into international markets remains limited due to regulatory hurdles and the specific demographic focus.

Demographics and Prescription Trends

• Heart failure affects approximately 6.2 million adults in the U.S. (CDC, 2020).
• African-American patients show a higher prevalence of heart failure and a faster progression, making targeted therapies like Bidil more relevant.
• Prescriptions are influenced by clinical guidelines emphasizing the use of these drugs in specified populations.

Competitive Landscape

• Generic versions of hydralazine hydrochloride and isosorbide dinitrate are available, lowering costs.
• No significant branded competitors target the same demographic with a similar formulation.

How Do Regulatory and Patent Factors Impact Market Trajectory?

Patent and Patent Expiry

• Bidil's patent expired in 2017, allowing generic manufacturers to enter the market.
• Generic versions are priced significantly lower, reducing revenue for originators.

Regulatory Environment

• FDA approval for the combination was based on clinical trials demonstrating efficacy in African-American patients.
• Strict approval and labeling restrict use to specific populations, limiting broader market expansion.

Reimbursement Policies

• Medicare and Medicaid reimbursements favor generic prescriptions, pressuring brand-name sales.
• Insurance coverage varies based on region and formulary preferences.

What Is the Financial Outlook for Hydralazine Hydrochloride and Isosorbide Dinitrate?

Revenue Trends

• Prior to patent expiry, Bidil achieved peak sales of approximately $70 million annually (IQVIA, 2016).
• Post-patent expiry, generic competition reduces market revenue; estimates suggest a decline exceeding 70% within two years.

Cost Structures and Profitability

• Production costs of generics are lower, but profit margins diminish due to price erosion.
• Originator companies face revenue reduction and may shift focus to specialty formulations or clinical research.

Investment and R&D Prospects

• Limited R&D pipelines for the specific combination.
• Potential for reformulation or new indications to revive commercial interest.

Forecasting

Year	Estimated Revenue (USD)	Notes
2022	$10–15 million	Generic competition dominates
2025	$5 million or less	Expected continued decline

Exogenous factors like shifts in heart failure management guidelines, emerging therapies, and healthcare policy changes could modify these projections.

How Do Broader Industry Trends Influence This Market?

Rise of New Heart Failure Treatments

• SGLT2 inhibitors (e.g., dapagliflozin) and angiotensin receptor neprilysin inhibitors (e.g., sacubitril/valsartan) now feature prominently in heart failure management.
• These offer alternative treatment pathways, potentially decreasing demand for traditional vasodilators like hydralazine and isosorbide dinitrate.

Growing Focus on Personalized Medicine

• Demographic-specific therapies are under scrutiny, and broader applicability of Bidil remains limited.
• Investment favors drugs with wider indications and broader patient bases.

Market Entry Barriers

• High regulatory and clinical trial costs deter new entrants.
• Existing generics and established guidelines limit the growth potential.

Key Takeaways

• The market for hydralazine hydrochloride and isosorbide dinitrate is shrinking due to patent expiration and generic competition.
• The primary use remains in heart failure management for African-American patients, limiting expansion.
• Revenue declined sharply post-patent expiry, with forecasts indicating continued erosion.
• New heart failure therapies present significant competition, reducing market attractiveness.
• Industry trends favor drugs with broader indications and newer mechanisms of action.

FAQs

1. Is there a pathway for hydralazine and isosorbide dinitrate to regain market share?
Limited; reintroduction would require new clinical evidence, expanded indications, or reformulations. Regulatory approval for broader populations faces significant hurdles.

2. Are there ongoing R&D efforts for new formulations?
No major pipelines target this specific combination; focus is on novel drugs with additional benefits or different mechanisms.

3. How does pricing compare between branded and generic versions?
Generics are priced approximately 60–80% lower than the branded BIDIL, leading to decreased revenue for originators.

4. What are the key regulatory challenges for this market?
Restrictions on use to certain populations limit commercial scope; also, approval of similar combinations requires substantial clinical data.

5. How do new heart failure treatments affect the market?
Emerging therapies with broader indications and superior efficacy reduce demand for traditional vasodilators, further shrinking the market.

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References

1. Centers for Disease Control and Prevention (CDC). Heart Failure Statistics. 2020.
2. IQVIA. Pharmaceutical Market Data. 2016.
3. FDA. Approved Drug Products: BIDIL. 2005.