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Last Updated: December 21, 2024

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 Drug Patent Profile


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Which patents cover Hydralazine Hydrochloride W/ Hydrochlorothiazide 50/50, and when can generic versions of Hydralazine Hydrochloride W/ Hydrochlorothiazide 50/50 launch?

Hydralazine Hydrochloride W/ Hydrochlorothiazide 50/50 is a drug marketed by Ivax Pharms and is included in one NDA.

The generic ingredient in HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 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 HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
Drug patent expirations by year for HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50

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SponsorPhase
Vanderbilt University Medical CenterPhase 4
National Center for Research Resources (NCRR)Phase 4
Vanderbilt UniversityPhase 1

See all HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 clinical trials

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Pharms HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 088357-001 Apr 10, 1984 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

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydralazine Hydrochloride with Hydrochlorothiazide 50/50

Introduction to Hydralazine Hydrochloride with Hydrochlorothiazide

Hydralazine hydrochloride and hydrochlorothiazide is a combination medication used to treat hypertension (high blood pressure) and congestive heart failure. This antihypertensive-diuretic combination works by relaxing blood vessels and increasing the supply of blood to the heart, while also reducing the amount of water in the body through increased urine production[1][3][5].

Market Growth Drivers

Rising Prevalence of Hypertension and Heart Diseases

The global hydralazine market is driven significantly by the increasing 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[2].

Increasing Geriatric Population

The elderly population is more susceptible to hypertension and heart diseases due to the loss of muscle mass and elasticity in blood vessels. This demographic shift is a key factor driving the growth of the hydralazine market[2].

Cost-Effectiveness

The availability of generic hydralazine and its cost-effectiveness compared to alternative medications are significant factors restraining market growth but also maintaining a steady demand for this medication[2].

Market Segmentation

By Type

The hydralazine 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[2].

By Application

The market is segmented into hospital, clinics, recovery centers, and others. Hospital pharmacies are expected to grow at a significant rate during the forecast period due to the high volume of patients treated in these settings[2].

By Distribution Channel

The market is classified into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to dominate the market due to the high demand for antihypertensive medications in these settings[2].

Regional Outlook

The global hydralazine 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. Europe and Asia Pacific are also key regions, with countries like the UK, Germany, and China contributing substantially to the market growth[2].

Competitive Landscape

The hydralazine market is competitive, with several key players including Novartis, Akorn, American Regent, Troikaa Pharmaceuticals, Zafa Pharmaceuticals, SteriMax, and X-Gen. These companies are involved in increasing research and development activities, strategic business expansions, and collaborative ventures to enhance their market presence[2].

Financial Trajectory

Market 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 primarily driven by the increasing prevalence of hypertension and heart diseases, as well as the growing geriatric population[2].

Revenue Projections

The market revenue is projected to increase significantly over the forecast period, driven by the rising demand for antihypertensive medications. The tablet segment, in particular, is expected to grow at a significant rate due to its widespread use in treating hypertension and heart failure[2].

Dosage and Administration

The dosage of hydralazine hydrochloride with hydrochlorothiazide is determined by individual titration. The usual dosage is one capsule twice daily, with strengths varying from 25 mg/25 mg to 100 mg/50 mg. The maintenance dose should be adjusted to the lowest effective level to minimize side effects[1][3].

Side Effects and Precautions

Despite its effectiveness, hydralazine has serious side effects, including low blood pressure, headache, rash, and dizziness. In rare cases, more severe side effects such as heart problems and lupus-like syndrome can occur. Hydrochlorothiazide can cause acute loss of fluid and electrolytes, and its use is generally not recommended in patients with severe renal disease or impaired hepatic function[1][2][3].

Pharmacokinetics

Hydrochlorothiazide is rapidly absorbed after oral administration, with peak concentrations occurring within 1-2.5 hours. It is eliminated rapidly by the kidneys, with 72-97% of the dose excreted in the urine. The pharmacokinetics can vary in patients with congestive heart failure, and food can enhance the bioavailability of hydralazine[1].

"Hydrochlorothiazide is rapidly absorbed, as indicated by peak concentrations 1-2.5 hours after oral administration. Plasma levels of the drug are proportional to dose; the concentration in whole blood is 1.6-1.8 times higher than in plasma."[1]

Conclusion

The market for hydralazine hydrochloride with hydrochlorothiazide is driven by the increasing prevalence of hypertension and heart diseases, along with the growing geriatric population. Despite potential side effects, the cost-effectiveness and widespread use of this medication ensure a steady demand. The competitive landscape is intense, with several key players involved in research and development to maintain market share.

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 geriatric population is a significant factor driving market growth.
  • The tablet form of hydralazine is widely used for treating hypertension and heart failure.
  • Hospital pharmacies are expected to dominate the distribution channel segment.
  • The market is competitive, with key players involved in research and development activities.

FAQs

Q: What is the primary use of hydralazine hydrochloride with hydrochlorothiazide?

A: Hydralazine hydrochloride with hydrochlorothiazide is primarily used to treat hypertension (high blood pressure) and congestive heart failure.

Q: What are the common side effects of hydralazine hydrochloride with hydrochlorothiazide?

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

Q: How is the dosage of hydralazine hydrochloride with hydrochlorothiazide determined?

A: The dosage is determined by individual titration, with the usual dosage being one capsule twice daily, and the strength varying from 25 mg/25 mg to 100 mg/50 mg.

Q: What is the impact of food on the bioavailability of hydralazine?

A: Food significantly enhances the bioavailability of hydralazine.

Q: Which segment is expected to dominate the distribution channel for hydralazine hydrochloride with hydrochlorothiazide?

A: Hospital pharmacies are expected to dominate the distribution channel segment.

Sources

  1. RxList: Apresazide (Hydralazine and Hydrochlorothiazide) - RxList
  2. Biospace: Global Hydralazine Market to Grow at a CAGR of 3.5% During Forecast Period - Emergen Research
  3. Drugs.com: Hydralazine / Hydrochlorothiazide Dosage Guide + Max Dose
  4. Science.gov: hydrochlorothiazide: Topics by Science.gov
  5. Mayo Clinic: Reserpine, hydralazine, and hydrochlorothiazide (oral route)

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