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Last Updated: December 22, 2024

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - Generic Drug Details

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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 Riconpharma Llc, 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 Aase og Ejnar Danielsen Foundation	Phase 4
The Novo Nordisk Foundation	Phase 4
Danish Heart Foundation	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

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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Glossary

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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
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	AB	RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Riconpharma Llc	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586-001	Apr 6, 2022	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988-001	Jan 17, 2024	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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

HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydralazine Hydrochloride and Isosorbide Dinitrate

Introduction

Hydralazine hydrochloride and isosorbide dinitrate are crucial medications, particularly for the treatment of heart failure and hypertension. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, investors, and healthcare professionals.

Growing Prevalence of Hypertension and Heart Diseases

The primary driver of the market for hydralazine hydrochloride and isosorbide dinitrate is the increasing prevalence of hypertension and heart diseases globally. According to the World Health Organization (WHO), approximately 1 billion people worldwide suffer from high blood pressure, making it a leading cause of death[4].

Demographic Factors

The geriatric population is another significant factor contributing to market growth. Elderly individuals are more susceptible to hypertension and heart diseases due to the loss of muscle mass and elasticity in blood vessels. This demographic shift is expected to continue driving demand for these medications[4].

Clinical Outcomes and Cost-Effectiveness

The fixed-dose combination of isosorbide dinitrate and hydralazine (ISDN/HYD) has been shown to improve clinical outcomes and reduce healthcare costs. In the African-American Heart Failure Trial (A-HeFT), ISDN/HYD therapy reduced heart failure-related hospitalizations and total healthcare costs, making it a cost-effective treatment option[2].

Market Size and Growth Rate

The global hydralazine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period. This growth is attributed to the increasing demand for antihypertensive medications and the expanding geriatric population[4].

Regional Outlook

The market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America, particularly the U.S., is a significant market due to the high prevalence of hypertension, affecting approximately 75 million adults[4].

Distribution Channels

The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to grow at a significant rate due to the high volume of prescriptions filled in these settings[4].

Competitive Landscape

The hydralazine market is highly competitive, with several key players involved in research and development, strategic expansions, and collaborative ventures. Major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen[4].

Regulatory Approvals and Exclusivity

Recent regulatory approvals, such as the FDA approval of Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets by RiconPharma LLC, have granted 180 days of Competitive Generic Therapy (CGT) exclusivity. This exclusivity period can significantly impact market dynamics by limiting competition during this time[3].

Financial Trajectory

The global hydralazine market was valued at a significant amount in 2023 and is anticipated to reach a higher value by 2030. The revenue growth is driven by the increasing adoption of hydralazine in various therapeutic applications and the expanding distribution channels[4].

Market Strategies and Promotions

Pharmaceutical companies spend a substantial portion of their sales on promotional activities to differentiate their products and maintain market share. This is particularly evident in markets with few sellers of differentiated products[4].

Eco-Friendly Analytical Methods

The development of eco-friendly analytical methods, such as the Green Analytical Quality by Design-based UPLC method for determining isosorbide dinitrate and hydralazine hydrochloride, is becoming increasingly important. These methods are validated for accuracy, reproducibility, and selectivity and are evaluated for their environmental benignity, which can contribute to the long-term sustainability of pharmaceutical production[1].

Pharmacokinetics and Bioavailability

Understanding the pharmacokinetics of hydralazine hydrochloride and isosorbide dinitrate is crucial for their effective use. The bioavailability of these drugs varies, with hydralazine showing non-linear kinetics and isosorbide dinitrate having highly variable bioavailability due to first-pass metabolism[5].

Side Effects and Safety Concerns

Common side effects of hydralazine include low blood pressure, headache, rash, and dizziness. Serious side effects such as heart problems and lupus-like syndrome can also occur. Managing these side effects and ensuring patient safety is a critical aspect of their use[5].

Key Takeaways

Growing Demand: The market is driven by the rising prevalence of hypertension and heart diseases.
Demographic Impact: The geriatric population significantly contributes to market growth.
Cost-Effectiveness: ISDN/HYD therapy reduces healthcare costs and improves clinical outcomes.
Market Growth: The global hydralazine market is expected to grow at a CAGR of 3.5%.
Regulatory Approvals: Recent FDA approvals and CGT exclusivity periods influence market dynamics.
Eco-Friendly Methods: The development of sustainable analytical methods is gaining importance.
Pharmacokinetics: Understanding the bioavailability and pharmacokinetics of these drugs is essential for their effective use.

FAQs

What is the primary driver of the hydralazine market?

The primary driver of the hydralazine market is the increasing prevalence of hypertension and heart diseases globally[4].

Which demographic factor significantly contributes to market growth?

The geriatric population is a significant demographic factor contributing to market growth due to their increased susceptibility to hypertension and heart diseases[4].

How does ISDN/HYD therapy impact healthcare costs?

ISDN/HYD therapy reduces heart failure-related hospitalizations and total healthcare costs, making it a cost-effective treatment option[2].

What is the expected CAGR of the global hydralazine market during the forecast period?

The global hydralazine market is expected to grow at a CAGR of 3.5% during the forecast period[4].

What are the common side effects of hydralazine hydrochloride?

Common side effects include low blood pressure, headache, rash, and dizziness. Serious side effects such as heart problems and lupus-like syndrome can also occur[5].

Sources

Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using a Green Analytical Quality by Design-based UPLC Method. Royal Society of Chemistry.
Cost-effectiveness of fixed-dose combination of isosorbide dinitrate and hydralazine in the treatment of heart failure. PubMed.
FDA Approval Letter for Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets. U.S. Food & Drug Administration.
Hydralazine Hydrochloride - Generic Drug Details. DrugPatentWatch.
Isosorbide and Hydralazine Tablets: Package Insert / Prescribing Info. Drugs.com.

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