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Last Updated: December 22, 2024

APRESAZIDE Drug Patent Profile


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When do Apresazide patents expire, and when can generic versions of Apresazide launch?

Apresazide is a drug marketed by Novartis and is included in three NDAs.

The generic ingredient in APRESAZIDE 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 APRESAZIDE
Drug patent expirations by year for APRESAZIDE

US Patents and Regulatory Information for APRESAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis APRESAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 084735-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 084810-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis APRESAZIDE hydralazine hydrochloride; hydrochlorothiazide CAPSULE;ORAL 084811-001 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

APRESAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Apresazide

Introduction

Apresazide, a combination of hydralazine and hydrochlorothiazide, is an antihypertensive-diuretic medication used to treat hypertension. Understanding the market dynamics and financial trajectory of this drug involves examining its usage, side effects, interactions, pricing, and the broader pharmaceutical market context.

Mechanism of Action and Clinical Use

Apresazide works by combining the vasodilating effects of hydralazine with the diuretic properties of hydrochlorothiazide. Hydralazine relaxes vascular smooth muscle, reducing peripheral vascular resistance and lowering blood pressure, while hydrochlorothiazide helps eliminate excess fluid and electrolytes, further reducing blood pressure[1][4].

Market Position

Apresazide is one of several antihypertensive medications available, and its market position is influenced by the presence of other effective treatments. The antihypertensive market is highly competitive, with various combination therapies and monotherapies available, such as PRESTALIA® (perindopril arginine/amlodipine besylate), which has shown significant efficacy in reducing blood pressure[2].

Pricing and Cost Considerations

The pricing of Apresazide can be a critical factor in its market dynamics. Pharmaceutical companies often face scrutiny over drug pricing, and significant price increases can lead to negative media coverage, which can impact the company's financial performance and capitalization[3].

Side Effects and Safety Profile

The safety profile of Apresazide includes several potential side effects, such as headache, anorexia, nausea, and cardiovascular issues like hypotension and tachycardia. These side effects can influence patient compliance and physician prescribing habits, affecting the drug's market trajectory[1].

Drug Interactions and Contraindications

Apresazide interacts with other medications, such as MAO inhibitors and digitalis, and has contraindications like hypersensitivity to hydralazine or hydrochlorothiazide, and certain heart conditions. These interactions and contraindications must be carefully managed to ensure patient safety and maintain market trust[1].

Regulatory and Approval Status

Apresazide has been approved for use in treating hypertension, but its regulatory status can change based on new clinical data or safety concerns. For instance, hydralazine, a component of Apresazide, is recommended by the WHO for pregnancy-induced hypertension but is not included in the WHO Prequalification Programme (PQP)[4].

Financial Performance and Capitalization

The financial performance of pharmaceutical companies producing Apresazide can be influenced by several factors, including media coverage of drug prices. Negative media coverage can lead to a reduction in stock value and affect the company's market capitalization. Studies have shown significant relationships between drug price news and financial metrics such as net margin, return on research capital, and market capitalization[3].

Market Competition

The antihypertensive market is highly competitive, with numerous drugs available. The success of Apresazide depends on its efficacy, safety profile, and pricing strategy compared to other treatments. For example, PRESTALIA® has demonstrated significant reductions in blood pressure and has a higher percentage of responders compared to monocomponent treatments, which could impact Apresazide's market share[2].

Patient and Physician Preferences

Patient and physician preferences play a crucial role in the market dynamics of Apresazide. Factors such as ease of administration, side effect profile, and overall efficacy influence prescribing decisions. For instance, hydralazine's use in pregnancy-induced hypertension, despite its potential for maternal and perinatal adverse effects, highlights the need for careful consideration in prescribing[4].

Procurement and Availability

The availability of Apresazide can be affected by procurement practices. In the absence of WHO-prequalified products, procurement agencies may need to conduct their own quality assessments. This can impact the drug's accessibility and market penetration, especially in regions where quality-assured products are preferred[4].

Media Coverage and Public Perception

Media coverage of drug prices and safety issues can significantly impact public perception and market dynamics. Negative coverage can lead to reduced sales and financial performance, while positive coverage can enhance the drug's reputation and market position[3].

Regulatory Environment

The regulatory environment, including changes in healthcare policies and reimbursement strategies, can influence the financial trajectory of Apresazide. For example, changes in formulary listings or reimbursement rates can affect the drug's market share and revenue[3].

Future Outlook

The future outlook for Apresazide depends on several factors, including ongoing clinical research, regulatory updates, and market competition. As new antihypertensive treatments emerge, Apresazide must maintain its competitive edge through demonstrated efficacy, safety, and cost-effectiveness.

Key Takeaways

  • Efficacy and Safety: Apresazide's combination of hydralazine and hydrochlorothiazide provides effective blood pressure management but comes with potential side effects.
  • Market Competition: The antihypertensive market is highly competitive, with Apresazide facing competition from other combination therapies.
  • Pricing and Media Coverage: Drug pricing and media coverage significantly impact the financial performance and market capitalization of pharmaceutical companies.
  • Regulatory Status: Apresazide's regulatory status, including WHO recommendations and procurement practices, affects its availability and market penetration.
  • Patient and Physician Preferences: Prescribing decisions are influenced by factors such as ease of administration, side effect profile, and overall efficacy.

FAQs

What is Apresazide used for?

Apresazide is used to treat hypertension (high blood pressure) by combining the vasodilating effects of hydralazine with the diuretic properties of hydrochlorothiazide.

What are the common side effects of Apresazide?

Common side effects include headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, and angina pectoris.

How does Apresazide interact with other medications?

Apresazide interacts with MAO inhibitors, digitalis, and other potent antihypertensive drugs, requiring careful management to avoid adverse effects.

Is Apresazide recommended for use in pregnancy?

Hydralazine, a component of Apresazide, is recommended by the WHO for pregnancy-induced hypertension but is associated with more maternal and perinatal adverse effects when used intravenously.

How does media coverage of drug prices affect the financial performance of pharmaceutical companies?

Negative media coverage of drug prices can lead to a reduction in stock value and affect the company's market capitalization, impacting financial performance and capitalization.

Sources

  1. RxList: Apresazide (Hydralazine and Hydrochlorothiazide) - RxList
  2. Pharmadesk: PRESTALIA® (perindopril arginine/amlodipine besylate) - Clinical Review
  3. ScholarWorks: Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Performance and Capitalization
  4. Global Health Supply Chain: HYDRALAZINE - Procurement and Quality Assurance

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