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Last Updated: December 22, 2024

APRESOLINE-ESIDRIX Drug Patent Profile


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Which patents cover Apresoline-esidrix, and what generic alternatives are available?

Apresoline-esidrix is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in APRESOLINE-ESIDRIX 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-ESIDRIX
Drug patent expirations by year for APRESOLINE-ESIDRIX

US Patents and Regulatory Information for APRESOLINE-ESIDRIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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-ESIDRIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydralazine (Apresoline)

Introduction to Hydralazine

Hydralazine, commonly known by its brand name Apresoline, is a medication used to treat high blood pressure (hypertension) and congestive heart failure. It belongs to the class of vasodilators, which work by relaxing blood vessels to reduce blood pressure.

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:

  • 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. In the U.S., hypertension affects around 75 million adults, which is roughly one in every three adults[1].
  • Increasing Geriatric Population: The elderly are more susceptible to hypertension and heart diseases due to the loss of muscle mass and elasticity in blood vessels, further driving the demand for hydralazine[1].

Market Segmentation

The hydralazine market is segmented based on several factors:

  • Type: The market is segmented into tablets and injections. The tablet form is widely used for treating hypertension and heart failure, while the injectable form is used for managing severe hypertension[1].
  • Indication: The market is classified into hypertension, congestive heart failure, and other indications. Hypertension is expected to grow significantly due to the rise in the geriatric population and changes in lifestyle[1].
  • Route of Administration: The market is segmented into oral and injectable forms. The oral segment is expected to grow significantly due to its ease of administration and lower cost compared to the injectable form[1].
  • Distribution Channel: The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to grow significantly during the forecast period[1].

Competitive Landscape

The competitive landscape of the hydralazine market is characterized by:

  • Research and Development: Increasing research and development activities by pharmaceutical and biotechnological companies are intensifying competition in the market[1].
  • Key Players: Companies such as Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, and Zafa Pharmaceuticals are among the key players in the hydralazine market[1].

Financial Trajectory

The financial trajectory of the hydralazine market is influenced by several factors:

  • Revenue Growth: The market is expected to see steady revenue growth driven by the increasing demand for hydralazine due to the rising prevalence of hypertension and heart diseases[1].
  • Regional Outlook: The market is segmented regionally, with North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa (MEA) being key regions. North America, particularly the U.S., is a significant market due to the high prevalence of hypertension[1].

Challenges and Restraints

Despite the growth prospects, the hydralazine market faces several challenges:

  • Side Effects: 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, necessitating close monitoring by healthcare professionals[1][2].
  • High Cost of Alternative Medications: The high cost of alternative medications and the availability of generic hydralazine can restrain market growth. However, the generic form of hydralazine also contributes to its widespread use[1].

Pharmacological and Clinical Aspects

  • Metabolism and Excretion: Hydralazine is metabolized by the liver and undergoes polymorphic acetylation. Slow acetylators require lower doses of the drug. Both the acetylated drug and unchanged drug are excreted in the urine and feces[2].
  • Dosage and Effects: For intravenous dosing, the blood-pressure-lowering effects of hydralazine occur within 5 to 30 minutes and last for 2 to 6 hours. For oral dosing, the effects occur within 20 to 30 minutes and last for 2 to 4 hours[2].

Precautions and Contraindications

  • Regular Monitoring: It is crucial for patients taking hydralazine to be monitored regularly by healthcare professionals to check for unwanted effects and ensure the medicine is working properly[5].
  • Contraindications: Hydralazine is contraindicated in patients with coronary artery disease due to its stimulation of the sympathetic nervous system, which can provoke myocardial ischemia. It should also be used with caution in breastfeeding women and in cases of aortic dissection[2].

Side Effects and Toxicity

  • Common Side Effects: Hydralazine can cause headaches, dizziness, loss of appetite, nausea, and vomiting. Less common side effects include constipation, decreased sexual ability, and shortness of breath with exercise[5].
  • Rare but Serious Side Effects: Rare cases of toxic epidermal necrolysis (TEN) and polyneuritis have been reported. Chronic toxicity could lead to drug-induced lupus erythematosus (DILE)[2].

Market Outlook and Projections

The hydralazine market is poised for steady growth driven by the increasing prevalence of hypertension and heart diseases. Here are some key projections:

  • Tablet Segment Growth: The tablet segment is expected to grow significantly due to its ease of administration and lower cost[1].
  • Hospital Pharmacies: Hospital pharmacies are expected to be a major distribution channel, contributing significantly to the market growth[1].

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 into tablets and injections, with the oral segment expected to grow significantly.
  • Key players are investing in research and development, intensifying competition.
  • Despite growth prospects, the market faces challenges such as side effects and the high cost of alternative medications.
  • Regular monitoring and adherence to precautions are crucial for patients taking hydralazine.

FAQs

Q: What is the primary use of hydralazine? A: Hydralazine is primarily used to treat high blood pressure (hypertension) and congestive heart failure.

Q: What are the common side effects of hydralazine? A: Common side effects include headaches, dizziness, loss of appetite, nausea, and vomiting.

Q: Why is hydralazine contraindicated in patients with coronary artery disease? A: Hydralazine is contraindicated in patients with coronary artery disease because it can stimulate the sympathetic nervous system, leading to increased cardiac output and oxygen demand, which can provoke myocardial ischemia.

Q: How is hydralazine metabolized and excreted? A: Hydralazine is metabolized by the liver and undergoes polymorphic acetylation. Both the acetylated drug and unchanged drug are excreted in the urine and feces.

Q: What are the rare but serious side effects of hydralazine? A: Rare but serious side effects include toxic epidermal necrolysis (TEN) and polyneuritis, and chronic toxicity could lead to drug-induced lupus erythematosus (DILE).

Sources

  1. Emergen Research: "Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period"[1].
  2. National Institutes of Health (NIH): "Hydralazine - StatPearls"[2].
  3. Mayo Clinic: "Hydralazine and hydrochlorothiazide (oral route) - Mayo Clinic"[5].

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