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Last Updated: February 22, 2024

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. Additional details are available on the heparin sodium; taurolidine profile page.

DrugPatentWatch® Generic Entry Outlook for Defencath

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 2, 2024. 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
Formulation / Manufacturing:see details
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*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for DEFENCATH

DEFENCATH is protected by four US patents.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Cormedix DEFENCATH heparin sodium; taurolidine SOLUTION;N/A 214520-002 Nov 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Cormedix DEFENCATH heparin sodium; taurolidine SOLUTION;N/A 214520-001 Nov 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Cormedix DEFENCATH heparin sodium; taurolidine SOLUTION;N/A 214520-002 Nov 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Cormedix DEFENCATH heparin sodium; taurolidine SOLUTION;N/A 214520-001 Nov 15, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 3083353
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 14562
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 14562
Estimated Expiration: ⤷  Try a Trial

Patent: 42945
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005022124
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 05617
Estimated Expiration: ⤷  Try a Trial

Patent: 08518739
Estimated Expiration: ⤷  Try a Trial

Patent: 13090933
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 14562
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 56946
Estimated Expiration: ⤷  Try a Trial

Patent: 51567
Estimated Expiration: ⤷  Try a Trial

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.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2023201019 ⤷  Try a Trial
Japan 2013090933 ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN ⤷  Try a Trial
Japan 5805617 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006049813 ⤷  Try a Trial
Denmark 1814562 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Medtronic
Baxter
Harvard Business School
Johnson and Johnson

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