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
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	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	214520-001	Nov 15, 2023	8,541,393
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	9,339,036

International Patents for DEFENCATH

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

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2006049813
Spain	2951567
Japan	5805617
Japan	2013090933	ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN
China	103083353	Antimicrobial Locking Solutions Comprising Taurinamide Derivatives And Biologically Acceptable Salts And Acids, With The Addition Of Small Concentrations Of Heparin
Portugal	1814562

DEFENCATH Market Analysis and Financial Projection

Last updated: April 23, 2026

DEFENCATH: Market Dynamics and Financial Trajectory

DEFENCATH has insufficient publicly verifiable, source-backed information to support a complete market and financial trajectory assessment.

No market sizing, revenue, pricing, payer coverage, launch timing, geography, competitor set, manufacturing scale, patent/market exclusivity status, or sales/market-share figures can be cited for “DEFENCATH” from reliable public sources in a way that supports an accurate, decision-grade analysis.

What is DEFENCATH in the market?

• No source-backed confirmation of the drug’s active ingredient, dosage form, route of administration, indication(s), or regulatory status (approval date, countries approved) is available for “DEFENCATH” in the provided context.

How does demand form around DEFENCATH?

• No source-backed evidence is available for:
  • target population size,
  • disease prevalence/incidence link to DEFENCATH’s indication,
  • expected treatment sequencing,
  • pricing basis by country (list price vs net price),
  • tender dynamics and reimbursement coverage.

What do pricing and reimbursement dynamics indicate?

• No source-backed information is available on:
  • payer reimbursement rates,
  • hospital formulary access,
  • national tender outcomes,
  • discounts, rebates, or outcomes-based contracting.

What does the competitive set look like?

• No source-backed identification of therapeutic alternatives (same mechanism, same line of therapy, or same clinical outcome) is available for “DEFENCATH.”

What is the financial trajectory (sales, profitability, and funding signals)?

• No source-backed sales data, procurement volumes, milestone payments, or financial reporting line items (revenue by product, territory, or indication) are available for “DEFENCATH.”

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Key Takeaways

• DEFENCATH cannot be assessed with decision-grade accuracy on market dynamics or financial trajectory based on publicly verifiable information in the provided context.
• No defensible, cite-able facts exist to support estimates of revenue growth, pricing power, payer pull-through, or competitive displacement.

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FAQs

1. What is DEFENCATH used for?
   No source-backed indication and drug identity can be confirmed from the provided context.

2. Has DEFENCATH launched in major markets?
   No source-backed launch timeline by geography can be confirmed.

3. What is DEFENCATH’s competitive landscape?
   The therapeutic alternatives cannot be identified with verifiable sourcing from the provided context.

4. What are DEFENCATH’s pricing and reimbursement outcomes?
   No cite-able reimbursement or pricing records are available from the provided context.

5. Is DEFENCATH profitable and growing in revenue?
   No source-backed sales or financial reporting exists for DEFENCATH in the provided context.

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References (APA)

[1] No reliable sources were provided or identifiable in the context to cite for DEFENCATH.