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Last Updated: December 22, 2024

APRESOLINE Drug Patent Profile


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

Apresoline is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in APRESOLINE is hydralazine hydrochloride; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.

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Summary for APRESOLINE
Drug patent expirations by year for APRESOLINE
Recent Clinical Trials for APRESOLINE

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SponsorPhase
Medical College of WisconsinN/A
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
University of CincinnatiPhase 2

See all APRESOLINE clinical trials

US Patents and Regulatory Information for APRESOLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis APRESOLINE hydralazine hydrochloride INJECTABLE;INJECTION 008303-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESOLINE hydralazine hydrochloride TABLET;ORAL 008303-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESOLINE hydralazine hydrochloride TABLET;ORAL 008303-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESOLINE hydralazine hydrochloride TABLET;ORAL 008303-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESOLINE-ESIDRIX hydralazine hydrochloride; hydrochlorothiazide TABLET;ORAL 012026-002 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

APRESOLINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Apresoline (Hydralazine)

Introduction

Apresoline, known generically as hydralazine, is a medication primarily used to treat hypertension and congestive heart failure. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Growth and Drivers

The global hydralazine market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% during the forecast period. The primary drivers of this growth include the rising prevalence of hypertension and heart diseases. 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].

Prevalence of Hypertension and Heart Diseases

Hypertension affects a significant portion of the global population. In the U.S., for example, hypertension affects around 75 million adults, which is approximately one in every three adults. This high prevalence, coupled with the increasing geriatric population, who are more susceptible to hypertension and heart diseases, fuels the demand for hydralazine[1].

Market Segmentation

The hydralazine market is segmented based on several factors:

Type

  • Tablets: Expected to grow significantly due to their ease of use and lower cost compared to injectable forms. Hydralazine tablets are available in 25 mg and 50 mg doses and are commonly used for treating hypertension and heart failure[1].
  • Injections: Used for managing severe hypertension and are further sub-segmented into intravenous (IV) and intramuscular (IM) forms[1].

Indication

  • Hypertension: The largest segment, driven by the high prevalence of hypertension globally.
  • Congestive Heart Failure: Another significant segment, with around 6.3 million adults in the U.S. suffering from this condition as of 2014[1].

Route of Administration

  • Oral: Expected to grow significantly due to its ease of administration and lower cost.
  • Injectable: Used in more severe cases and further segmented into IV and IM forms[1].

Distribution Channel

  • Hospital Pharmacies: Expected to grow significantly, given the high number of hospitals and the critical nature of the treatments administered there.
  • Retail Pharmacies: Also a significant segment, providing easy access to patients.
  • Online Pharmacies: Growing in importance due to convenience and accessibility[1].

Competitive Landscape

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

Financial Performance and Capitalization

The financial performance of pharmaceutical companies producing hydralazine can be significantly influenced by several factors, including media coverage of drug prices. Research has shown that mass media coverage of drug prices can impact the financial performance and capitalization of pharmaceutical companies. For instance, negative media coverage can lead to a reduction in stock value and affect the company's profit margin and market share[3].

Impact of Drug Price News

Drug price news can have a profound impact on the financial trajectory of pharmaceutical companies. High drug prices, particularly for medications like hydralazine that are essential for managing chronic conditions, can lead to public and political scrutiny. This scrutiny can result in decreased financial performance and capitalization for the companies involved. The high cost of research and development (R&D) is often cited as a reason for high drug prices, but significant price increases without evident innovations can provoke public and media backlash[3].

Regional Outlook

The global hydralazine market is segmented regionally, with North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa being key regions. The U.S. and Europe are significant markets due to the high prevalence of hypertension and heart diseases in these regions. The Asia Pacific region is also expected to grow significantly due to an increasing geriatric population and rising healthcare expenditure[1].

Side Effects and Safety Concerns

While hydralazine is effective in managing hypertension and heart failure, it comes with several potential side effects. These include low blood pressure, headache, rash, dizziness, and in rare cases, more serious side effects such as heart problems and lupus-like syndrome. These side effects necessitate close monitoring by healthcare professionals[1][4].

Adverse Reactions

Adverse reactions to hydralazine can be significant and include neurologic, hematologic, and hypersensitive reactions. Neurologic reactions may include peripheral neuritis, dizziness, and tremors. Hematologic reactions can involve blood dyscrasias, such as reduction in hemoglobin and red cell count. Hypersensitive reactions may include rash, urticaria, and fever[4].

Dosage and Administration

Hydralazine is available in both oral and injectable forms. The dosage and administration must be carefully managed to avoid adverse reactions. For example, patients with suspected coronary artery disease or cerebral vascular accidents should use hydralazine with caution[4].

Quality of Care and Performance Metrics

The quality of care for patients with hypertension is a critical factor in the market dynamics of hydralazine. Performance metrics such as the percentage of patients with controlled blood pressure below 140/90 mmHg are important indicators. Despite improvements, there remains a significant gap in the quality of care, with lower performing plans having potential for significant improvement[2].

Key Takeaways

  • The global hydralazine market is expected to grow at a CAGR of 3.5% driven by the rising prevalence of hypertension and heart diseases.
  • The market is segmented by type, indication, route of administration, and distribution channel.
  • Media coverage of drug prices can significantly impact the financial performance and capitalization of pharmaceutical companies.
  • Hydralazine has several potential side effects that require close monitoring.
  • Quality of care metrics are crucial in evaluating the effectiveness of hydralazine treatment.

FAQs

What is the primary driver of the global hydralazine market growth?

The primary driver of the global hydralazine market growth is the rising prevalence of hypertension and heart diseases.

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

The oral segment, particularly tablets, is expected to grow significantly due to their ease of use and lower cost.

How does media coverage of drug prices affect pharmaceutical companies?

Media coverage of drug prices can impact the financial performance and capitalization of pharmaceutical companies, particularly if the coverage is negative, leading to reduced stock value and affected profit margins.

What are some of the potential side effects of hydralazine?

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

Which regions are significant markets for hydralazine?

North America, Europe, and the Asia Pacific are significant markets due to the high prevalence of hypertension and heart diseases in these regions.

Sources

  1. Emergen Research: Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period.
  2. National Quality Forum: Hypertension Measures.
  3. ScholarWorks: Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies.
  4. Drugs.com: Apresoline: Package Insert / Prescribing Information.

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