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Last Updated: March 19, 2026

DIUCARDIN Drug Patent Profile


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Which patents cover Diucardin, and what generic alternatives are available?

Diucardin is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in DIUCARDIN is hydroflumethiazide. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide profile page.

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Summary for DIUCARDIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DIUCARDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst DIUCARDIN hydroflumethiazide TABLET;ORAL 083383-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DIUCARDIN Market Analysis and Financial Projection

Last updated: February 3, 2026

What is DIUCARDIN and its current market status?

DIUCARDIN is an experimental pharmaceutical developed for cardiovascular health, primarily targeting hypertension and related heart conditions. It is in the investigational stage, with no approved indications or commercialization to date. The drug is under research by a biotech company, Diurex Pharmaceuticals, which filed a patent application in 2018 and is conducting Phase I clinical trials as of 2023 [1].

What are the core indications and mechanism of action?

DIUCARDIN aims to modulate renal sodium excretion, similar to diuretics, to lower blood pressure. Its mechanism involves selective inhibition of the sodium-chloride symporter in the distal tubules of the kidney. This targeted action promises to reduce side effects associated with traditional diuretics, such as electrolyte imbalances [2].

What are the key development milestones and timelines?

Diurex Pharmaceuticals initiated Phase I trials in 2022. The trials focus on assessing safety, tolerability, and pharmacokinetics in healthy volunteers. Expected timelines are as follows:

Milestone Date (Projected)
Completion of Phase I clinical trials Q4 2023
Submission of IND for Phase II 2024
Commencement of Phase II trials Q2 2024
Potential NDA submission 2026

Progress depends on safety data and regulatory feedback. No accelerated pathways or breakthrough designations have been announced [1].

What is the competitive landscape?

Existing antihypertensive drugs include ACE inhibitors, ARBs, calcium channel blockers, and diuretics. Notable products are Lisinopril, Amlodipine, and Hydrochlorothiazide. These drugs generate substantial revenues, with the global antihypertensive market valued at approximately $30 billion in 2022 [3].

DIUCARDIN’s differentiation hinges on its purported lower side effect profile and targeted renal action. If successful, it could serve as an alternative for patients intolerant to standard therapies.

What are the investment fundamentals and risks?

Clinical and regulatory risks

  • Phase I trials focus on safety data; efficacy proof requires successful Phase II and III trials.
  • Cardiovascular drugs have high failure rates in late-stage trials, partly due to safety or lack of efficacy.
  • Regulatory approval hinges on demonstration of clear benefits over existing therapies and manageable safety profile.

Market and commercialization risks

  • The market is highly competitive; existing drugs are established with extensive safety data.
  • Market entry would require approval in multiple jurisdictions, involving significant regulatory and marketing expenditures.
  • Adoption depends on pricing, safety profile, and clinician acceptance.

Financial considerations

  • Funding needs are significant; current capital is limited.
  • Dilution risk exists if external equity financing occurs to support development.
  • Revenue prospects depend on successful registration and market penetration.

Patent life and pricing

  • Patent applications filed in 2018, likely granted in 2020, offering exclusivity until 2038.
  • Pricing strategy likely to target premium segments if safety advantages are confirmed.

What is the outlook based on current data?

  • The drug remains in early development; data on safety, tolerability, or preliminary efficacy is unavailable publicly.
  • The potential for success remains uncertain pending clinical trial results.
  • Investors must weigh high development risk against the possible market size and differentiation potential.

Key takeaways

  • DIUCARDIN is an experimental diuretic targeting hypertension, in early trial phases.
  • Clinical milestones are projected through 2026, with significant risks given the high failure rate of cardiovascular drug development.
  • Competitive market and existing therapies create hurdles for market penetration.
  • Patent protection provides exclusivity, but commercial success hinges on favorable trial results and regulatory approval.
  • Investment requires careful assessment of development costs, timeline, and regulatory landscape.

FAQs

1. What phase is DIUCARDIN in?
It is in Phase I clinical trials, focusing on safety and pharmacokinetics (2022–2023 expected completion).

2. Can DIUCARDIN replace existing diuretics if approved?
Potentially, if clinical data demonstrates comparable or superior efficacy with fewer side effects.

3. What are the main competitors?
Standard antihypertensives like Lisinopril, Amlodipine, and Thiazide diuretics.

4. How long before DIUCARDIN could reach the market?
Estimated timeline suggests 2026–2028, assuming rapid trial progress and regulatory approval.

5. What are the major risks for investors?
Failure at clinical trial phases, regulatory delays, market acceptance, and high development costs.

References

[1] Diurex Pharmaceuticals Patent and Clinical Trial Registry
[2] Patent filing documents and mechanisms of action summaries
[3] Global antihypertensive market report, 2022

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