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Last Updated: December 22, 2024

DRALZINE Drug Patent Profile


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When do Dralzine patents expire, and what generic alternatives are available?

Dralzine is a drug marketed by Teva and is included in one NDA.

The generic ingredient in DRALZINE is hydralazine hydrochloride. There are twenty-one drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dralzine

A generic version of DRALZINE was approved as hydralazine hydrochloride by STRIDES PHARMA on September 27th, 1983.

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Summary for DRALZINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 118
Patent Applications: 1,172
DailyMed Link:DRALZINE at DailyMed
Drug patent expirations by year for DRALZINE

US Patents and Regulatory Information for DRALZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva DRALZINE hydralazine hydrochloride TABLET;ORAL 084301-001 Approved Prior to Jan 1, 1982 DISCN 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

DRALZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydralazine

Market Overview

Hydralazine, a medication used to treat high blood pressure (hypertension) and other cardiovascular conditions, is experiencing significant growth in the global market. Here are the key dynamics and financial projections for this drug.

Growth Drivers

The global hydralazine market is driven by several key factors:

  • Rising Prevalence of Hypertension and Heart Diseases: The increasing number of people suffering from hypertension and heart diseases is a major driver. 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].
  • Aging Population: The growing geriatric population is more susceptible to hypertension and heart diseases, further boosting the demand for hydralazine[1].
  • Low Cost and Wide Availability: Hydralazine is one of the most commonly prescribed drugs due to its low cost and extensive availability, including generic forms[1].

Market Segmentation

The hydralazine market is segmented in several ways:

  • By Type: The market is segmented into tablets and injections. The tablet segment is expected to grow significantly due to its ease of use and lower cost compared to injectable forms[1].
  • By Indication: The market is classified into hypertension, congestive heart failure, and other indications. Hypertension is expected to grow at a significant rate due to the rising prevalence of chronic diseases and lifestyle changes[1].
  • By Route of Administration: The market is segmented into oral and injectable forms, with the oral segment expected to dominate due to its convenience and lower cost[1].
  • By Distribution Channel: The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies, with hospital pharmacies expected to grow significantly[1].

Competitive Landscape

The competitive landscape of the hydralazine market is intense, with several key players:

  • Major Players: Companies such as Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen are prominent in the market[1].
  • Research and Development: Increasing research and development activities, along with strategic business expansions and collaborative ventures, are intensifying the competition[1].

Financial Projections

The financial trajectory of the hydralazine market is promising:

  • CAGR: The global hydralazine market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period[1].
  • Market Value: While the exact current market value is not specified, the growth rate indicates a steady increase in market size over the forecast period[1].
  • Regional Outlook: The market is expected to grow significantly in regions such as North America, Europe, and Asia Pacific, driven by the increasing prevalence of hypertension and heart diseases in these areas[1].

Challenges and Restraints

Despite the growth drivers, there are several challenges and restraints:

  • Side Effects: Hydralazine has several potential side effects, including low blood pressure, headache, rash, and dizziness. In rare cases, more serious side effects like heart problems and lupus-like syndrome can occur, necessitating close monitoring by healthcare professionals[1][2].
  • High Cost of Alternative Medications: While hydralazine is relatively low-cost, the high cost of alternative medications can sometimes restrain market growth[1].

Regional Performance

The market performance varies by region:

  • North America: This region is significant due to the high prevalence of hypertension, with approximately 75 million adults in the U.S. suffering from the condition[1].
  • Europe: Europe also sees a substantial market due to the high incidence of heart failure, with around 26 million people affected in 2012[1].
  • Asia Pacific: The growing geriatric population and increasing prevalence of chronic diseases in this region are driving market growth[1].

Distribution Channels

The distribution channels play a crucial role in the market dynamics:

  • Hospital Pharmacies: Expected to grow significantly due to the high demand for hydralazine in hospital settings[1].
  • Retail Pharmacies: Also important, especially for outpatient treatments[1].
  • Online Pharmacies: Growing in importance due to convenience and accessibility[1].

Key Takeaways

  • The global hydralazine market is driven by the rising prevalence of hypertension and heart diseases.
  • The market is segmented by type, indication, route of administration, and distribution channel.
  • Major players are investing in research and development, intensifying competition.
  • The market is expected to grow at a CAGR of 3.5% during the forecast period.
  • Side effects and the high cost of alternative medications are key restraints.

FAQs

What is the primary use of hydralazine?

Hydralazine is primarily used to treat high blood pressure (hypertension) and to control high blood pressure in mothers during pregnancy or in emergency situations[2].

What are the common side effects of hydralazine?

Common side effects include low blood pressure, headache, rash, and dizziness. More serious side effects can include heart problems and lupus-like syndrome[1][2].

Which regions are expected to see significant growth in the hydralazine market?

North America, Europe, and Asia Pacific are expected to see significant growth due to the high prevalence of hypertension and heart diseases in these regions[1].

Who are the major players in the hydralazine market?

Major players include Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen[1].

What is the expected CAGR of the global hydralazine market?

The global hydralazine market is expected to grow at a CAGR of 3.5% during the forecast period[1].

Cited Sources

  1. Emergen Research: Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period[1].
  2. Mayo Clinic: Hydralazine (oral route)[2].
  3. Emergen Research: Hydralazine Market Trends: Drivers, Restraints and Growth Factors[3].
  4. Valuates Reports: Global Hydralazine Market Research Report 2024[4].
  5. Drugs.com: Hydralazine Alternatives Compared[5].

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