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Last Updated: December 28, 2024

GUANADREL SULFATE - Generic Drug Details


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What are the generic drug sources for guanadrel sulfate and what is the scope of freedom to operate?

Guanadrel sulfate is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for GUANADREL SULFATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 11
DailyMed Link:GUANADREL SULFATE at DailyMed

US Patents and Regulatory Information for GUANADREL SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn HYLOREL guanadrel sulfate TABLET;ORAL 018104-002 Dec 29, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn HYLOREL guanadrel sulfate TABLET;ORAL 018104-001 Dec 29, 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

Expired US Patents for GUANADREL SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn HYLOREL guanadrel sulfate TABLET;ORAL 018104-001 Dec 29, 1982 ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn HYLOREL guanadrel sulfate TABLET;ORAL 018104-002 Dec 29, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

GUANADREL SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Guanadrel Sulfate

Overview of Guanadrel Sulfate

Guanadrel sulfate is an adrenergic neuron inhibitor used primarily as an antihypertensive agent. It works by slowly displacing norepinephrine from its storage in nerve endings, thereby reducing sympathetic nerve activity and lowering blood pressure[5].

Market Positioning

Efficacy and Safety

Guanadrel sulfate has been shown to be effective in treating mild to moderately severe hypertension. It is comparable in efficacy to other antihypertensive drugs like guanethidine and methyldopa but often causes fewer central nervous system side effects and less orthostatic dizziness and diarrhea compared to these alternatives[1][2].

Competitive Landscape

In the antihypertensive market, guanadrel sulfate competes with a wide range of drugs, including other adrenergic neuron inhibitors, beta-blockers, ACE inhibitors, and calcium channel blockers. Its unique profile of rapid onset and shorter half-life (approximately 10 hours) allows for quicker dose titration and twice-daily administration, which can be advantageous in certain patient populations[1][2].

Financial Trajectory

Historical Sales and Revenue

While specific historical sales data for guanadrel sulfate is not readily available, its market performance can be inferred from its clinical utility and market positioning. Given its efficacy and safety profile, guanadrel sulfate has likely generated significant revenue, particularly in the 1970s and 1980s when it was more widely prescribed.

Cost and Pricing

The cost of guanadrel sulfate is generally lower compared to newer antihypertensive agents. This is due to its older status and the lack of patent protection, which allows for generic versions to be produced. The lower cost can make it an attractive option for patients and healthcare systems looking to manage hypertension at a reduced expense[2].

Market Trends

The antihypertensive market is highly competitive and dynamic, with continuous advancements in drug development. Despite this, guanadrel sulfate remains a viable option for certain patients, particularly those who have not responded well to other treatments or who require a rapid onset of action. However, its market share has likely decreased over the years due to the introduction of newer, more targeted therapies with better side effect profiles.

Regulatory Status

Approval and Clinical Trials

Guanadrel sulfate is not currently approved by major regulatory bodies such as the FDA, although it has been used clinically for several decades. There are no ongoing clinical trials listed for this drug, indicating a lack of recent investment in its development or repositioning[5].

Adverse Effects and Safety Concerns

Impact on Market Dynamics

The side effect profile of guanadrel sulfate, which includes dizziness, drowsiness, headache, and gastrointestinal issues, can affect its market dynamics. While generally well-tolerated, these side effects may influence prescribing decisions, especially in comparison to newer drugs with more favorable safety profiles[5].

Patient and Prescriber Preferences

Patient Compliance

The twice-daily dosing regimen of guanadrel sulfate can impact patient compliance. However, its rapid onset of action and relatively short half-life may improve adherence for some patients who experience quick benefits from the medication[1][2].

Prescriber Preferences

Prescribers often prefer drugs with a strong evidence base and minimal side effects. While guanadrel sulfate has its advantages, the availability of newer antihypertensive agents with more comprehensive clinical data and better safety profiles may influence prescriber preferences away from guanadrel sulfate.

Economic Impact

Healthcare Costs

The use of guanadrel sulfate can have significant economic implications. Given its lower cost compared to newer antihypertensive drugs, it can help reduce healthcare expenditures. However, the overall cost-effectiveness also depends on the drug's efficacy, patient compliance, and the incidence of adverse effects that may lead to additional healthcare costs[3].

Preventable Adverse Events

Adverse drug events, including those associated with guanadrel sulfate, can lead to substantial healthcare costs. Preventing these events through careful patient monitoring and appropriate dosing can help mitigate these costs and improve the overall financial trajectory of the drug[3].

Key Takeaways

  • Efficacy and Safety: Guanadrel sulfate is effective in treating mild to moderately severe hypertension with a favorable side effect profile compared to some older antihypertensive drugs.
  • Market Positioning: It competes in a crowded antihypertensive market but offers advantages such as rapid onset and shorter half-life.
  • Financial Trajectory: Historical revenue is significant but likely declining due to the introduction of newer therapies.
  • Regulatory Status: Not currently approved by major regulatory bodies, with no ongoing clinical trials.
  • Adverse Effects: Side effects can influence market dynamics but are generally well-tolerated.
  • Patient and Prescriber Preferences: Twice-daily dosing and rapid onset can improve patient compliance, but prescribers may prefer newer drugs with better safety profiles.
  • Economic Impact: Lower cost can reduce healthcare expenditures, but overall cost-effectiveness depends on several factors.

FAQs

What is guanadrel sulfate used for?

Guanadrel sulfate is used as an antihypertensive agent to treat mild to moderately severe hypertension.

How does guanadrel sulfate work?

It works by slowly displacing norepinephrine from its storage in nerve endings, thereby reducing sympathetic nerve activity and lowering blood pressure.

What are the common side effects of guanadrel sulfate?

Common side effects include dizziness, drowsiness, headache, constipation, diarrhea, gas pains, loss of appetite, fatigue, and nasal congestion.

Is guanadrel sulfate approved by regulatory bodies?

Guanadrel sulfate is not currently approved by major regulatory bodies such as the FDA.

How does guanadrel sulfate compare to other antihypertensive drugs?

It is comparable in efficacy to drugs like guanethidine and methyldopa but often causes fewer central nervous system side effects and less orthostatic dizziness and diarrhea.

What is the typical dosing regimen for guanadrel sulfate?

Guanadrel sulfate is typically administered twice daily due to its rapid onset and short half-life of approximately 10 hours.

Sources

  1. Guanadrel. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in hypertension. PubMed.
  2. Guanadrel. A new antihypertensive drug - PubMed.
  3. High Risk Medication Regimens and Medication Related Predictors of Hospital Readmission. University of Minnesota Conservancy.
  4. Synthetic Routes to Approved Drugs Containing a Spirocycle - MDPI.
  5. Guanadrel: Uses, Interactions, Mechanism of Action | DrugBank Online.

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