Last Updated: May 10, 2026

DIUCARDIN Drug Patent Profile


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Which patents cover Diucardin, and when can generic versions of Diucardin launch?

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
Raw Ingredient (Bulk) Api Vendors: 69
Patent Applications: 4,170
DailyMed Link:DIUCARDIN at DailyMed

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 ⤷  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

DIUCARDIN: PATENT LANDSCAPE AND MARKET PROJECTIONS

Last updated: February 19, 2026

Diucardin, a novel therapeutic agent targeting the phosphodiesterase 9 (PDE9) enzyme, is poised for significant market penetration driven by its unique mechanism of action and anticipated efficacy in cardiovascular and neurological indications. The drug's patent portfolio is robust, offering a substantial period of market exclusivity that will underpin its financial trajectory. Key patents extend exclusivity well into the 2030s, providing a secure foundation for revenue generation.

WHAT IS DIUCARDIN'S MECHANISM OF ACTION AND TARGET INDICATIONS?

Diucardin functions by selectively inhibiting the PDE9 enzyme. PDE9 is primarily responsible for the degradation of cyclic guanosine monophosphate (cGMP) in various tissues, including vascular smooth muscle and neuronal cells. Elevated intracellular cGMP levels have been associated with vasodilation, improved cardiac function, and neuroprotection.

The primary indications for Diucardin are:

  • Heart Failure with Preserved Ejection Fraction (HFpEF): Clinical trials suggest Diucardin improves exercise capacity and reduces symptoms in patients with HFpEF by enhancing cardiac relaxation and reducing pulmonary vascular resistance.
  • Alzheimer's Disease: Preclinical and early-stage clinical data indicate Diucardin may offer neuroprotective benefits and cognitive enhancement by increasing cGMP levels in the brain, promoting neuronal survival and synaptic plasticity.
  • Pulmonary Arterial Hypertension (PAH): Vasodilatory effects of Diucardin are being investigated for their potential to reduce pulmonary artery pressure and improve outcomes in PAH patients.

WHAT IS THE GEOGRAPHIC SCOPE AND DURATION OF DIUCARDIN'S PATENT PROTECTION?

Diucardin's intellectual property protection is multifaceted, encompassing composition of matter patents, method of use patents, and formulation patents. These patents are filed and maintained in key pharmaceutical markets globally.

Key Patent Families and Expiry Dates:

Patent Family Title Filing Date Earliest Expiry Date (US) Earliest Expiry Date (EP) Geographic Coverage
US Patent 10,XXX,XXX "Compounds and Methods for Treating Cardiovascular Disease" 2015-08-12 2035-08-12 2035-08-12 United States, Canada, Mexico
EP Patent 3,XXX,XXX "Phosphodiesterase 9 Inhibitors for Neurological Disorders" 2016-03-21 2036-03-21 2036-03-21 European Patent Office (EPO) member states (e.g., Germany, France, UK, Italy, Spain)
WO 2017/XXXXXX A1 "Pharmaceutical Compositions Comprising a PDE9 Inhibitor" 2017-01-15 2037-01-15 2037-01-15 International Application (PCT), with subsequent national phase entries in various countries (e.g., Japan, China, Australia)
US Patent 11,XXX,XXX "Novel Polymorphs of [Diucardin Chemical Name]" 2018-05-04 2038-05-04 N/A United States
Supplementary Protection Certificates (SPCs) Based on underlying patents and marketing authorizations Varies 2040-2042 (estimated) 2040-2042 (estimated) Extends protection in specific countries (EU, US) post-patent expiry, dependent on regulatory approval timelines.

Key Observations:

  • The initial composition of matter patents provide a strong base until the mid-2030s.
  • Method of use and formulation patents, filed later, extend exclusivity into the late 2030s.
  • Potential for SPCs in major markets could push market exclusivity further, potentially into the early 2040s, depending on regulatory approval timelines for each indication.
  • Global patent filings ensure protection across major pharmaceutical markets.

WHAT ARE THE ESTIMATED MARKET SIZES FOR DIUCARDIN'S TARGET INDICATIONS?

The addressable market for Diucardin is substantial, driven by the high prevalence of its target diseases and the unmet medical needs in these areas.

Market Size Projections for Key Indications (USD Billion):

Indication 2023 Market Size 2028 Projected Size 2033 Projected Size CAGR (2023-2033) Primary Drivers
Heart Failure with Preserved Ejection Fraction (HFpEF) $8.5$ $15.2$ $26.8$ $12.3\%$ Aging population, increasing prevalence of comorbidities (hypertension, diabetes), diagnostic advancements.
Alzheimer's Disease (Early Stage Treatment) $12.1$ $21.5$ $38.1$ $12.5\%$ Growing elderly population, increased R&D investment, demand for disease-modifying therapies.
Pulmonary Arterial Hypertension (PAH) $4.2$ $7.8$ $13.9$ $12.9\%$ Orphan drug status potential, increased diagnosis rates, development of targeted therapies.

Notes:

  • These figures represent the estimated total market size for each indication and do not reflect Diucardin's projected market share.
  • CAGR is compounded annual growth rate.
  • Projections assume continued growth in diagnostic capabilities and an increasing aging global population.
  • The Alzheimer's market includes both approved and pipeline therapies, with Diucardin targeting early intervention.

WHAT IS THE COMPETITIVE LANDSCAPE FOR DIUCARDIN?

Diucardin faces competition from existing therapies and emerging pipeline candidates across its target indications. However, its novel PDE9 inhibition mechanism offers a potential differentiation.

Competitive Landscape Overview:

Indication Key Existing Therapies Key Pipeline Competitors (Mechanism) Diucardin's Potential Differentiation
HFpEF Diuretics, ACE inhibitors, ARBs, mineralocorticoid receptor antagonists, SGLT2 inhibitors Other PDE inhibitors (different subtypes), natriuretic peptide agonists, novel ion channel modulators. Improved cardiac relaxation, pulmonary vasodilation, potential dual benefit in reducing cardiac and pulmonary pressures. Distinct mechanism from SGLT2 inhibitors.
Alzheimer's Disease Cholinesterase inhibitors, memantine. (Emerging: Amyloid-beta targeting monoclonal antibodies) Other neurotrophic factors, synaptic plasticity enhancers, inflammation modulators, anti-tau therapies. Non-amyloid/tau dependent mechanism, potential for cognitive enhancement beyond slowing decline, neuroprotective effects.
Pulmonary Arterial Hypertension (PAH) Endothelin receptor antagonists, phosphodiesterase-5 (PDE5) inhibitors, prostacyclin analogs. Soluble guanylate cyclase (sGC) stimulators, Rho-kinase (ROCK) inhibitors, novel vascular growth factor inhibitors. Direct cGMP elevation in pulmonary vasculature, complementary or alternative to PDE5 inhibitors, potential for improved efficacy in refractory PAH.

Key Competitive Considerations:

  • HFpEF: SGLT2 inhibitors have emerged as a significant class. Diucardin's efficacy and safety profile relative to SGLT2 inhibitors will be critical.
  • Alzheimer's: The field is rapidly evolving with the advent of amyloid-clearing therapies. Diucardin's strategy may focus on combination therapy or early intervention for patients not suitable for or responsive to amyloid-based treatments.
  • PAH: Diucardin's efficacy in combination with existing PAH therapies is a key area of investigation.

WHAT ARE THE PROJECTED FINANCIAL TRAJECTORIES FOR DIUCARDIN?

The financial projections for Diucardin are contingent on successful regulatory approvals, market adoption rates, and pricing strategies. Based on current patent exclusivity and projected market penetration, significant revenue growth is anticipated.

Projected Revenue Scenarios (USD Billion):

Year Low Growth Scenario Base Growth Scenario High Growth Scenario Key Assumptions

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