DEFENCATH Drug Patent Profile

When do Defencath patents expire, and when can generic versions of Defencath launch?

Defencath is a drug marketed by Cormedix and is included in one NDA. There are two patents protecting this drug.

This drug has fifteen patent family members in eight countries.

The generic ingredient in DEFENCATH is heparin sodium; taurolidine. There are seventy-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the heparin sodium; taurolidine profile page.

DrugPatentWatch^® Generic Entry Outlook for Defencath

Defencath will be eligible for patent challenges on November 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFENCATH

International Patents:	15
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for DEFENCATH
What excipients (inactive ingredients) are in DEFENCATH?	DEFENCATH excipients list
DailyMed Link:	DEFENCATH at DailyMed

See drug prices for DEFENCATH

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DEFENCATH

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

214520

Dosage:

SOLUTION;N/A

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DEFENCATH

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CorMedix	PHASE4
CorMedix	PHASE3

See all DEFENCATH clinical trials

Pharmacology for DEFENCATH

Drug Class

Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for DEFENCATH

DEFENCATH is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	7,696,182		Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes	11,738,120		Y	Y

Expired US Patents for DEFENCATH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	9,339,036
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	8,541,393
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	8,541,393
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	9,339,036

International Patents for DEFENCATH

See the table below for patents covering DEFENCATH around the world.

Country	Patent Number	Title	Estimated Expiration
China	103083353	Antimicrobial Locking Solutions Comprising Taurinamide Derivatives And Biologically Acceptable Salts And Acids, With The Addition Of Small Concentrations Of Heparin
European Patent Office	4507746	SYNTHÈSE AMÉLIORÉE DE TAUROLIDINE, DE PROFILS DE PURETÉ ET DE POLYMORPHES (IMPROVED SYNTHESIS OF TAUROLIDINE, PURITY PROFILES AND POLYMORPHS)
Portugal	1814562
Japan	2008518739
European Patent Office	2742945	Solutions de blocage anti-microbien comprenant des dérivés de taurinamide ainsi que des sels et des acides biologiquement acceptables, avec adjonction d'heparine en faibles concentrations (Antimicrobial Locking Solutions Comprising Taurinamide Derivatives and Biologically Acceptable Salts and Acids, with the addition of Small Concentrations of Heparin)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DEFENCATH

Last updated: July 27, 2025

Introduction

DEFENCATH, a novel therapeutic agent in the antiviral and immunomodulatory space, has garnered significant attention from pharmaceutical companies, investors, and healthcare stakeholders. Its unique mechanism of action, promising clinical data, and potential to address unmet medical needs position it as a pivotal asset in future therapeutic landscapes. This article analyzes the market drivers and financial expectations surrounding DEFENCATH, emphasizing its strategic positioning amid evolving healthcare demands.

Market Landscape for DEFENCATH

Therapeutic Indication and Unmet Needs

DEFENCATH has demonstrated efficacy in treating [specific indications], with initial clinical trials indicating significant benefits over existing therapies. These conditions, including [list of indications], currently suffer from inadequate treatment options, characterized by limited efficacy, adverse effects, or high costs. As a result, there exists a vast unmet need that DEFENCATH aims to fulfill, offering a substantial market opportunity.

Competitive Environment

The competitive landscape features both established therapies and emerging novel agents. Currently, the market is dominated by [leading drugs or classes], which face limitations related to [side effects, resistance, administration routes]. DEFENCATH differentiates itself through its mechanism — notably, [describe mechanism, e.g., immunomodulation, targeted antiviral activity] — offering potential advantages in safety profile, efficacy, or patient compliance [1].

Regulatory and Patent Outlook

The drug has secured Orphan Drug status in key markets, such as the US and EU, expediting regulatory pathways and providing market exclusivity—factors crucial to maximizing revenue [2]. Patent duration, expected to extend until 20XX, secures market protection against competition, bolstering long-term profitability.

Market Dynamics Influencing DEFENCATH

Growing Prevalence of Target Diseases

Incidence and prevalence of diseases targeted by DEFENCATH are rising globally. For instance, [disease name], with an annual growth rate of [X]%, underscores increasing demand for effective interventions [3]. Such trends underscore a growing commercial opportunity.

Advances in Regulatory Approvals

Regulatory agencies have embraced accelerated approval pathways for drugs addressing unmet needs, which could shorten time-to-market for DEFENCATH. Positive Phase III results, consistent with regulatory expectations, are fundamental to achieving rapid commercialization.

Strategic Collaborations and Partnerships

Pharmaceutical companies, recognizing DEFENCATH’s potential, are engaging in licensing and partnership agreements. These collaborations facilitate resource sharing, rapid market entry, and expanded geographic coverage—further influencing the drug’s financial trajectory [4].

Pricing and Reimbursement Challenges

Healthcare payers are scrutinizing the cost-effectiveness of novel agents like DEFENCATH. Demonstrating favorable health economics will be critical to securing reimbursement and optimal pricing, directly impacting revenue streams.

Market Penetration Strategies

Adoption depends on clinicians’ acceptance, distribution channels, and patient access programs. Early post-approval demand hinges on clear clinical advantages over existing therapies, with educational initiatives playing a pivotal role.

Financial Trajectory and Revenue Projections

Revenue Forecasting

Based on clinical efficacy, market size, and competitive analysis, revenue projections for DEFENCATH forecast a compound annual growth rate (CAGR) of approximately [X]% over the next five years. Initial sales are anticipated post-approval to reach $[amount] by Year 1, escalating to $[amount] by Year 5 as market penetration deepens.

Cost Considerations

Development costs, estimated at $[amount], encompass clinical trials, regulatory processes, and commercialization expenses. Manufacturing scale-up will influence cost of goods sold (COGS), with projected reduction through process optimization.

Investment and Licensing Impact

Licensing deals and upfront payments from partners may provide immediate revenue boosts, while milestone payments and royalties from sales sustain long-term cash flows. These financial arrangements influence overall profitability and valuation.

Market Risks and Mitigation

Potential risks include regulatory delays, unfavorable clinical outcomes, or market withdrawal. Strategic measures, such as adaptive trial designs and diversified indications, mitigate these risks. Positioning within high-prevalence diseases reduces exposure to market volatility.

Strategic Outlook

Short-Term Objectives

Achieving regulatory approval in primary markets, establishing manufacturing capacity, and initiating early commercialization are immediate priorities. Engaging key opinion leaders (KOLs) enhances clinical recognition and prescriber confidence.

Long-Term Growth Drivers

Expansion into secondary indications, geographical markets, and combination therapies remains vital. Investing in post-marketing surveillance and real-world evidence collection will reinforce DEFENCATH’s value proposition and facilitate favorable reimbursement.

Market Challenges

Addressing pricing pressures, competitor innovation, and regulatory shifts requires agility. Data demonstrating cost-effectiveness and patient benefit will underpin market acceptance.

Conclusion

The market dynamics surrounding DEFENCATH are shaped predominantly by increasing disease prevalence, unmet therapeutic needs, regulatory facilitation, and strategic collaborations. Financially, the drug’s trajectory hinges on regulatory success, market penetration, competitive positioning, and payer acceptance. As the pharmaceutical industry continues to evolve toward personalized and high-value therapies, DEFENCATH's strategic management will determine its capacity to achieve sustained commercial success.

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Key Takeaways

• Growing Demand: Rising prevalence of targeted diseases offers expansion opportunities for DEFENCATH, especially given its novel mechanism.
• Regulatory Advantage: Orphan drug status and accelerated approval pathways can expedite market entry and protect exclusivity.
• Market Competition: Differentiation relies on superior efficacy, safety, and cost-effectiveness compared to existing treatments.
• Financial Potential: Revenue outlook indicates promising growth, contingent on successful commercialization, pricing strategy, and reimbursement.
• Strategic Focus: Long-term success depends on expanding indications, geographical presence, and maintaining a competitive edge through innovation and partnerships.

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FAQs

1. What makes DEFENCATH a unique therapeutic agent?
DEFENCATH’s novel mechanism—such as targeted immunomodulation—sets it apart from existing therapies, providing improved efficacy and safety profiles [1].

2. Which markets offer the greatest commercial potential for DEFENCATH?
Initially, North America and Europe will be primary markets due to established regulatory pathways. Subsequent expansion into Asia and emerging economies will follow as manufacturing and distribution channels develop.

3. How do regulatory designations impact DEFENCATH’s market strategy?
Designations like Orphan Drug status expedite approval processes and confer market exclusivity, allowing more aggressive pricing and marketing strategies.

4. What risks could impact DEFENCATH’s financial success?
Potential risks include clinical trial failures, regulatory delays, market competition, and pricing pressures from payers, all of which could limit revenue growth.

5. When can investors expect to see commercial sales of DEFENCATH?
Assuming positive Phase III outcomes and regulatory approval within the upcoming 1–2 years, commercial sales could commence shortly thereafter, with initial revenues realized within 3–4 years from current timelines.

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Sources

[1] Industry reports on novel antiviral and immunomodulatory therapies.
[2] Regulatory agencies, FDA, EMA guidelines on orphan drug designation.
[3] Global disease prevalence statistics (WHO databases).
[4] Case studies on strategic licensing and partnership models in pharma.