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Last Updated: December 22, 2024

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE - Generic Drug Details


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What are the generic sources for guanethidine monosulfate; hydrochlorothiazide and what is the scope of freedom to operate?

Guanethidine monosulfate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE at DailyMed

US Patents and Regulatory Information for GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ESIMIL guanethidine monosulfate; hydrochlorothiazide TABLET;ORAL 013553-001 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

GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Guanethidine Monosulfate and Hydrochlorothiazide

Introduction

Guanethidine monosulfate and hydrochlorothiazide are two antihypertensive drugs that have been used in the management of hypertension for several decades. Understanding their market dynamics and financial trajectories is crucial for pharmaceutical companies, healthcare providers, and policymakers.

Historical Context of Guanethidine Monosulfate

Discovery and Initial Use

Guanethidine was first introduced in the 1960s as a treatment for moderate to severe hypertension. It works by inhibiting the release of norepinephrine from postganglionic sympathetic nerve terminals, thereby reducing blood pressure[4].

Mechanism of Action

Guanethidine's mechanism involves blocking the release of norepinephrine, leading to a depletion of norepinephrine stores in nerve endings. This action results in decreased peripheral resistance and cardiac output, which in turn lowers blood pressure[4].

Clinical Use and Acceptance

Studies have shown that guanethidine is effective in reducing blood pressure in patients with mild to moderate hypertension, often with a good benefit-to-risk ratio. However, its use has been limited by side effects, particularly at higher doses, and the availability of newer antihypertensive agents[2].

Market Dynamics for Guanethidine Monosulfate

Decline in Usage

Over the years, the use of guanethidine has declined significantly due to the introduction of newer, more effective, and safer antihypertensive drugs. Drugs like ACE inhibitors, ARBs, and calcium channel blockers have become preferred choices due to their better side effect profiles and greater efficacy[3].

Financial Impact

The decline in usage has naturally led to a decrease in the financial performance of guanethidine. Pharmaceutical companies have seen reduced sales and revenue from this drug as it is no longer a first-line treatment for hypertension.

Current Status

Guanethidine is now mostly used in specific cases where other treatments have failed or are contraindicated. Its niche market status means it is no longer a significant contributor to the overall antihypertensive drug market.

Historical Context of Hydrochlorothiazide

Discovery and Initial Use

Hydrochlorothiazide, a thiazide diuretic, was introduced in the 1950s and quickly became a cornerstone in the treatment of hypertension. It works by increasing sodium and water excretion, which reduces blood volume and subsequently lowers blood pressure[2].

Mechanism of Action

Hydrochlorothiazide acts on the kidneys to increase the excretion of sodium and chloride ions, leading to a decrease in blood volume and a reduction in blood pressure. It is often used in combination with other antihypertensive agents to enhance its effects[2].

Clinical Use and Acceptance

Hydrochlorothiazide has remained a widely used antihypertensive drug due to its efficacy, low cost, and relatively good safety profile. It is often used as a first-line treatment for mild to moderate hypertension and is commonly combined with other drugs like ACE inhibitors or ARBs[3].

Market Dynamics for Hydrochlorothiazide

Continued Usage

Unlike guanethidine, hydrochlorothiazide continues to be a staple in the treatment of hypertension. Its widespread use is due to its effectiveness, affordability, and the fact that it is often prescribed in combination with other antihypertensive medications.

Financial Performance

The financial performance of hydrochlorothiazide remains strong due to its continued use and low production costs. It is one of the most prescribed antihypertensive drugs globally, contributing significantly to the revenue of pharmaceutical companies.

Generic Status

Hydrochlorothiazide is available in generic form, which has further increased its accessibility and usage. The generic status has also led to competitive pricing, making it an attractive option for both patients and healthcare providers.

Comparative Financial Trajectory

Guanethidine Monosulfate

  • Declining Revenue: The revenue from guanethidine has been declining over the years due to reduced usage and the preference for newer antihypertensive drugs.
  • Niche Market: It now serves a niche market, primarily for patients who cannot use other antihypertensive medications.
  • Limited Investment: Pharmaceutical companies are less likely to invest heavily in the development and marketing of guanethidine due to its limited market potential.

Hydrochlorothiazide

  • Stable Revenue: Hydrochlorothiazide continues to generate stable revenue due to its widespread use and combination therapy regimens.
  • Generic Market: The availability of generic versions has maintained its market presence and affordability.
  • Ongoing Investment: Pharmaceutical companies continue to invest in the production and distribution of hydrochlorothiazide due to its consistent demand.

Key Takeaways

  • Guanethidine Monosulfate: Its use has declined significantly due to the availability of newer and safer antihypertensive drugs, leading to reduced financial performance.
  • Hydrochlorothiazide: It remains a widely used and financially viable antihypertensive drug due to its efficacy, low cost, and continued prescription in combination therapies.
  • Market Dynamics: The antihypertensive drug market is highly competitive, with newer drugs often replacing older ones. However, hydrochlorothiazide's generic status and combination therapy use have ensured its continued market presence.

FAQs

Q: What is the primary mechanism of action of guanethidine monosulfate?

A: Guanethidine monosulfate works by inhibiting the release of norepinephrine from postganglionic sympathetic nerve terminals, leading to a depletion of norepinephrine stores and a reduction in blood pressure[4].

Q: Why has the use of guanethidine monosulfate declined?

A: The use of guanethidine has declined due to the introduction of newer antihypertensive drugs with better efficacy and safety profiles, as well as its side effects at higher doses[2].

Q: What is the role of hydrochlorothiazide in the treatment of hypertension?

A: Hydrochlorothiazide is a thiazide diuretic that reduces blood pressure by increasing sodium and water excretion, and it is often used as a first-line treatment or in combination with other antihypertensive medications[2].

Q: Why is hydrochlorothiazide still widely used despite the availability of newer drugs?

A: Hydrochlorothiazide remains widely used due to its efficacy, low cost, and the fact that it is often prescribed in combination with other antihypertensive medications, making it a cost-effective and effective treatment option[3].

Q: How has the generic status of hydrochlorothiazide affected its market presence?

A: The generic status of hydrochlorothiazide has increased its accessibility and usage by making it more affordable, which has helped maintain its market presence and financial viability.

Sources

  1. The effect of guanethidine and hydrochlorothiazide on blood pressure and tyrosine hydroxylase activity - PubMed[1]
  2. Patient acceptance of guanethidine as therapy for mild to moderate hypertension - PubMed[2]
  3. Hypertension, Essential - MalaCards[3]
  4. Guanethidine: Uses, Interactions, Mechanism of Action - DrugBank[4]
  5. Essential Medicines in the United States - The BMJ[5]

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