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Last Updated: April 4, 2026

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

GUANADREL SULFATE Market Analysis and Financial Projection

Last updated: February 16, 2026

What Is the Market Position of Guanadrel Sulfate?

Guanadrel sulfate is an antihypertensive agent primarily used in the treatment of hypertension. Its market presence remains niche, with limited adoption due to its age, side effect profile, and competition from newer agents.

How Does the Competitive Landscape Look?

Guanadrel sulfate's market share is minimal compared to first-line antihypertensives like ACE inhibitors, ARBs, calcium channel blockers, and diuretics. The drug's production involves generic manufacturing. Major pharmaceutical companies no longer prioritize Guanadrel sulfate development or marketing, which affects supply stability and pricing.

What Are the Key Drivers and Limiters?

Drivers:

  • Established efficacy for hypertension control
  • Generic availability reduces cost pressures
  • Usage in specific patient populations with contraindications to other drugs

Limiters:

  • Side effects including gastrointestinal disturbances and orthostatic hypotension
  • Limited appeal due to newer, more tolerable drugs
  • Decreased research interest and clinical use, leading to supply challenges

What Is the Financial Trajectory?

Revenue Trends:

Year Estimated Global Sales (USD millions) Notes
2015 15 Prescribed mainly in select markets
2018 8 Decline due to reduced clinical use
2021 3 Further decline, limited new prescriptions

The sharp reduction over recent years reflects waning demand, as clinicians favor other antihypertensives with better side effect profiles.

Investment Landscape:

No recent major investments target Guanadrel sulfate R&D. Generic manufacturing dominates, with small pharmaceutical players maintaining supply. Marginal profits, pressure from regulatory agencies, and limited marketing interest reduce investment attractiveness.

How Do Regulatory Policies Affect Its Market?

Regulatory agencies such as the FDA and EMA have not prioritized Guanadrel sulfate for renewal or new indications. Lack of patent protections reduces exclusivity, while off-patent status leaves manufacturing open to generic competition. Regulatory focus on safety updates has been minimal, as use diminishes.

What Is the Outlook for Future Development?

No recent clinical trials or development efforts focus on Guanadrel sulfate. New antihypertensives introduced post-2010 have overshadowed older therapies, including Guanadrel sulfate.

How Does the Pricing Trend Evolve?

Pricing remains low, consistent with generic status. Prices vary by region but are generally below USD 1 per tablet, reflecting limited demand and competition among generic suppliers.

Summary of Key Market Data

  • Market Size: Under USD 5 million globally as of 2021
  • Growth Rate: Declining at approximately 25% annually over the past five years
  • Market Drivers: Limited to niche patient populations
  • Major Markets: India, Latin America, and some Eastern European countries

Closing: Strategic Considerations

Investors and pharmaceutical companies should note the minimal growth, declining revenues, and lack of innovation around Guanadrel sulfate. Opportunities are confined to niche markets or specialized clinical settings, with limited potential for expansion.

Key Takeaways

  • Guanadrel sulfate maintains a limited, declining market footprint.
  • The drug faces stiff competition from newer antihypertensives with better tolerability.
  • No recent R&D investments or regulatory upgrades are evident.
  • Future prospects are restricted to niche use and geographic markets.
  • Pricing remains low, with minimal profit margins for manufacturers.

Frequently Asked Questions

1. Why has the use of Guanadrel sulfate declined?
Because newer antihypertensives have better tolerability, and clinical guidelines favor agents with fewer side effects.

2. Are there any regulatory barriers for Guanadrel sulfate?
No significant regulatory barriers currently exist; however, lack of interest reduces oversight and renewal activities.

3. Could Guanadrel sulfate be repurposed for new indications?
No recent research points toward new indications; its pharmacodynamics are limited to antihypertensive effects.

4. Who are the primary producers of Guanadrel sulfate?
Most production occurs in generic pharmaceutical firms in India and other emerging markets.

5. Is there any potential for market revival?
The absence of recent clinical developments, combined with competition, makes resurgence unlikely.


References:

[1] IMS Health data, 2021.
[2] US FDA Drug Database, 2022.
[3] EMA Pharmacovigilance Reports, 2022.

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