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DEFENCATH Drug Patent Profile

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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 four patents protecting this drug.

This drug has fourteen 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

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Summary for DEFENCATH

International Patents:	14
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DEFENCATH
What excipients (inactive ingredients) are in DEFENCATH?	DEFENCATH excipients list
DailyMed Link:	DEFENCATH at DailyMed

Drug patent expirations by year for DEFENCATH

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

Generic Entry Date for DEFENCATH^: ⤷ Sign Up* 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.

Pharmacology for DEFENCATH

Drug Class	Anti-coagulant Unfractionated Heparin

US Patents and Regulatory Information for DEFENCATH

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DEFENCATH is ⤷ Sign Up.

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.

Patents protecting DEFENCATH

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A CATHETER LOCK SOLUTION TO REDUCE CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT PATIENTS RECEIVING HEMODIALYSIS THROUGH A CENTRAL VENOUS CATHETER

Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A CATHETER LOCK SOLUTION TO REDUCE CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT PATIENTS RECEIVING HEMODIALYSIS THROUGH A CENTRAL VENOUS CATHETER

FDA Regulatory Exclusivity protecting DEFENCATH

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

International Patents for DEFENCATH

When does loss-of-exclusivity occur for DEFENCATH?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

Patent: 1094679
Patent: Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Estimated Expiration: ⤷ Sign Up

Patent: 3083353
Patent: Antimicrobial Locking Solutions Comprising Taurinamide Derivatives And Biologically Acceptable Salts And Acids, With The Addition Of Small Concentrations Of Heparin
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 14562
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 14562
Patent: SOLUTIONS DE BLOCAGE ANTI-MICROBIEN COMPRENANT DES DERIVES 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)
Estimated Expiration: ⤷ Sign Up

Patent: 42945
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Germany

Patent: 2005022124
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 05617
Estimated Expiration: ⤷ Sign Up

Patent: 08518739
Estimated Expiration: ⤷ Sign Up

Patent: 13090933
Patent: ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 14562
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 56946
Estimated Expiration: ⤷ Sign Up

Patent: 51567
Estimated Expiration: ⤷ Sign Up

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

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

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Country	Patent Number	Title	Estimated Expiration
Germany	202005022124		⤷ Sign Up
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)	⤷ Sign Up
Portugal	1814562		⤷ Sign Up
Denmark	1814562		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration