HYDRALAZINE HYDROCHLORIDE - Generic Drug Details

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

Hydralazine hydrochloride is the generic ingredient in twenty-eight branded drugs marketed by Novartis, Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Riconpharma Llc, and is included in one hundred and twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for hydralazine hydrochloride. Forty-three suppliers are listed for this compound.

Summary for HYDRALAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	28
Applicants:	52
NDAs:	125
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	65
Patent Applications:	1,703
Drug Prices:	Drug price trends for HYDRALAZINE HYDROCHLORIDE
What excipients (inactive ingredients) are in HYDRALAZINE HYDROCHLORIDE?	HYDRALAZINE HYDROCHLORIDE excipients list
DailyMed Link:	HYDRALAZINE HYDROCHLORIDE at DailyMed

See drug prices for HYDRALAZINE HYDROCHLORIDE

Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE

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

Sponsor	Phase
McMaster University	Phase 3
Shahid Sadoughi University of Medical Sciences and Health Services	Phase 3
National Institute for Medical Research Development (NIMAD), Iran	Phase 3

See all HYDRALAZINE HYDROCHLORIDE clinical trials

Pharmacology for HYDRALAZINE HYDROCHLORIDE

Drug Class	Arteriolar Vasodilator
Physiological Effect	Arteriolar Vasodilation

Medical Subject Heading (MeSH) Categories for HYDRALAZINE HYDROCHLORIDE

Antihypertensive Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE

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

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West Ward	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	088240-001	May 27, 1983		DISCN	No	No
Novartis	APRESOLINE	hydralazine hydrochloride	TABLET;ORAL	008303-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Watson Labs	HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	hydralazine hydrochloride; hydrochlorothiazide	CAPSULE;ORAL	085446-001	Mar 4, 1982		DISCN	No	No
Strides Pharma	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	TABLET;ORAL	200770-004	Jun 25, 2019		DISCN	No	No

HYDRALAZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydralazine Hydrochloride

Market Overview

The global hydralazine market is poised for significant growth, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of hydralazine hydrochloride.

Growing Prevalence of Hypertension and Heart Diseases

The primary driver of the hydralazine market 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 globally[1].

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 hydralazine[1].

Market Segmentation

By Type

The hydralazine market is segmented into tablets and injections. The tablet segment is expected to grow significantly due to its ease of administration and lower cost compared to injectable forms. Hydralazine tablets are available in various strengths, such as 25 mg and 50 mg, and are widely used for treating hypertension and heart failure[1].

By Route of Administration

The market is also segmented by route of administration into oral and injectable forms. The oral segment is anticipated to dominate the market due to its convenience and cost-effectiveness. The injectable segment, further sub-segmented into intravenous (IV) and intramuscular (IM), is used for managing severe hypertension[1].

By Indication

Hydralazine is used to treat hypertension, congestive heart failure, and other conditions. The hypertension segment is expected to grow significantly due to the rising prevalence of high blood pressure globally[1].

By Distribution Channel

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[1].

Competitive Landscape

The hydralazine market is highly competitive, with several key players involved in research and development, strategic expansions, and collaborative ventures. Some of the major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen[1].

Financial Trajectory

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[1].

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[1].

Revenue Forecast

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].

Challenges and Restraints

Side Effects and Safety Concerns

Despite its widespread use, hydralazine has several side effects, including low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects such as heart problems and lupus-like syndrome can occur. These safety concerns necessitate close monitoring by healthcare professionals[1].

High Cost of Alternative Medications

The high cost of alternative antihypertensive medications and the availability of generic hydralazine are factors that can restrain market growth. However, the cost-effectiveness of hydralazine, especially in its generic form, continues to drive its adoption[1].

Regulatory and Quality Control Aspects

Method Validation and Quality Control

Methods for the assay of hydralazine hydrochloride have been validated for accuracy, reproducibility, and cost-effectiveness. These methods ensure the quality of hydralazine in both pure and pharmaceutical formulations, adhering to international standards such as those set by the International Conference on Harmonization (ICH) Q2 (R1)[5].

Market Strategies and Promotions

Promotional Expenditures

The pharmaceutical industry, including the hydralazine market, is known for significant promotional expenditures. Companies spend a substantial portion of their sales on promotion to differentiate their products and maintain market share. This is particularly evident in markets with few sellers of differentiated products[3].

Key Takeaways

• The global hydralazine market is driven by the rising prevalence of hypertension and heart diseases.
• The geriatric population is a significant demographic factor contributing to market growth.
• The market is segmented by type, route of administration, indication, and distribution channel.
• Key players are engaged in intense competition through research and development and strategic ventures.
• The market is expected to grow at a CAGR of 3.5% during the forecast period.
• Side effects and safety concerns are critical factors that need to be managed.
• Regulatory and quality control measures are essential for ensuring the quality of hydralazine products.

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.

Which segment is expected to grow significantly in the hydralazine market?

The tablet segment is expected to grow significantly due to its ease of administration and lower cost compared to injectable forms.

What are the common side effects of hydralazine?

Common side effects include low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects such as heart problems and lupus-like syndrome can occur.

Who are the major players in the hydralazine market?

Major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen.

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.

Sources

1. Emergen Research: Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period[1].
2. DailyMed: Hydralazine Hydrochloride tablet, film coated[2].
3. Federal Trade Commission: Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets[3].
4. Valuates Reports: Global Hydralazine Market Research Report 2024[4].
5. Scientific Research Publishing: Method Verification and Validation of Hydralazine Hydrochloride[5].