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Last Updated: December 22, 2024

GUANETHIDINE MONOSULFATE - Generic Drug Details


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What are the generic drug sources for guanethidine monosulfate and what is the scope of patent protection?

Guanethidine monosulfate is the generic ingredient in three branded drugs marketed by Watson Labs and Novartis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for guanethidine monosulfate.

Summary for GUANETHIDINE MONOSULFATE
Medical Subject Heading (MeSH) Categories for GUANETHIDINE MONOSULFATE

US Patents and Regulatory Information for GUANETHIDINE MONOSULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis ISMELIN guanethidine monosulfate TABLET;ORAL 012329-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis ESIMIL guanethidine monosulfate; hydrochlorothiazide TABLET;ORAL 013553-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs GUANETHIDINE MONOSULFATE guanethidine monosulfate TABLET;ORAL 086113-001 Mar 26, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis ISMELIN guanethidine monosulfate TABLET;ORAL 012329-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs GUANETHIDINE MONOSULFATE guanethidine monosulfate TABLET;ORAL 086114-001 Mar 26, 1985 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Guanethidine Monosulfate

Introduction

Guanethidine monosulfate, an antihypertensive agent, has been used in the management of moderate and severe hypertension. To understand its market dynamics and financial trajectory, it is essential to delve into its mechanism of action, clinical use, and the evolving landscape of hypertension treatment.

Mechanism of Action and Clinical Use

Guanethidine monosulfate acts by inhibiting the release of norepinephrine at nerve endings, leading to a depletion of norepinephrine in peripheral sympathetic nerve terminals and tissues. This action results in decreased heart rate and relaxation of blood vessels, thereby reducing blood pressure[2][5].

Historical Market Presence

Guanethidine monosulfate was first introduced in the 1960s by Novartis (then Ciba Geigy) under the brand name Ismelin. It was widely used for managing hypertension, particularly in cases where other treatments were ineffective or as an adjunct therapy[2].

Market Trends and Competition

Decline in Usage

Over the years, the use of guanethidine monosulfate has declined significantly due to the introduction of newer, more effective, and safer antihypertensive agents. Drugs like ACE inhibitors (e.g., lisinopril), angiotensin II receptor blockers (e.g., valsartan), and calcium channel blockers have become preferred treatments due to their better side effect profiles and greater efficacy[3].

Regulatory Status

Guanethidine monosulfate is still listed as an approved drug, but its marketing and sales have been largely discontinued by major pharmaceutical companies. Generic versions were available until recent years, but even these have seen a significant reduction in production and distribution[2].

Financial Trajectory

Revenue Decline

The revenue generated from guanethidine monosulfate has steadily declined as the drug has been replaced by more modern antihypertensive medications. The last major marketing efforts for this drug were seen in the late 20th century, and since then, it has been largely phased out of clinical practice.

Production and Distribution Costs

The costs associated with producing and distributing guanethidine monosulfate have become less justifiable given the reduced demand. This has led to a decrease in the number of manufacturers and distributors involved in its production.

Pricing

Historical pricing data indicates that guanethidine monosulfate was relatively inexpensive compared to newer antihypertensive drugs. However, the current pricing is largely irrelevant due to its limited availability and use[2].

Clinical Trials and Research

Lack of Recent Trials

There have been no significant clinical trials focused on guanethidine monosulfate in recent years. The drug's mechanism of action and efficacy have been well established, but it is no longer a subject of active research or development[2].

Pharmacoeconomics

Cost-Effectiveness

From a pharmacoeconomic perspective, guanethidine monosulfate is no longer considered a cost-effective option for managing hypertension. Newer drugs offer better outcomes with fewer side effects, making them more favorable in terms of cost-benefit analysis[3].

Manufacturers and Packagers

Discontinued by Major Players

Major pharmaceutical companies like Novartis have discontinued the production and marketing of guanethidine monosulfate. Generic manufacturers have also reduced their involvement due to declining demand[2].

Patents and Intellectual Property

Expired Patents

The patents for guanethidine monosulfate have long since expired, which has allowed for generic production. However, the lack of market demand has made it unprofitable for most companies to continue manufacturing the drug[2].

Conclusion

Guanethidine monosulfate, once a significant player in the management of hypertension, has seen a substantial decline in its market presence and financial trajectory. The introduction of newer, more effective antihypertensive agents has rendered it largely obsolete.

Key Takeaways

  • Mechanism of Action: Guanethidine monosulfate inhibits the release of norepinephrine, leading to decreased blood pressure.
  • Historical Use: Introduced in the 1960s, it was widely used until the advent of newer antihypertensive drugs.
  • Market Decline: The drug has been largely phased out due to the introduction of safer and more effective treatments.
  • Financial Impact: Revenue has declined significantly, and production costs are no longer justifiable.
  • Clinical Trials: No recent clinical trials have focused on this drug.
  • Pharmacoeconomics: Newer drugs offer better cost-effectiveness and outcomes.

FAQs

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

A: Guanethidine monosulfate acts by inhibiting the release of norepinephrine at nerve endings, leading to a depletion of norepinephrine in peripheral sympathetic nerve terminals and tissues.

Q: Why has the use of guanethidine monosulfate declined?

A: The use of guanethidine monosulfate has declined due to the introduction of newer, more effective, and safer antihypertensive agents.

Q: Is guanethidine monosulfate still available in the market?

A: While it is still listed as an approved drug, its availability is highly limited due to discontinued production and distribution by major pharmaceutical companies.

Q: What are the current alternatives to guanethidine monosulfate for managing hypertension?

A: Current alternatives include ACE inhibitors, angiotensin II receptor blockers, and calcium channel blockers, among others.

Q: Are there any ongoing clinical trials for guanethidine monosulfate?

A: There are no significant ongoing clinical trials focused on guanethidine monosulfate due to its obsolete status in clinical practice.

Sources

  1. MedchemExpress: Guanethidine sulfate - MedchemExpress.com
  2. DrugBank: Guanethidine - DrugBank
  3. MalaCards: Hypertension, Essential - MalaCards
  4. SelleckChem: Guanethidine Monosulfate - SelleckChem
  5. DrugBank: Guanethidine monosulfate - DrugBank Online

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