Heparin sodium; taurolidine - Generic Drug Details

What are the generic sources for heparin sodium; taurolidine and what is the scope of freedom to operate?

Heparin sodium; taurolidine is the generic ingredient in one branded drug marketed by Cormedix and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Heparin sodium; taurolidine has fourteen patent family members in eight countries.

One supplier is listed for this compound.

Summary for heparin sodium; taurolidine

International Patents:	14
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	heparin sodium; taurolidine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for heparin sodium; taurolidine

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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 heparin sodium; taurolidine

Drug Class

Anti-coagulant Unfractionated Heparin

Anatomical Therapeutic Chemical (ATC) Classes for heparin sodium; taurolidine

B01AB	Heparin group
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

C05BA	Heparins or heparinoids for topical use
C05B	ANTIVARICOSE THERAPY
C05	VASOPROTECTIVES
C	Cardiovascular system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for heparin sodium; taurolidine

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			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	214520-001	Nov 15, 2023		RX	Yes	Yes			Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes			Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes			Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023		RX	Yes	Yes			Y	Y
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023		RX	Yes	Yes			Y	Y

International Patents for heparin sodium; taurolidine

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
Germany	202005022124
Japan	2013090933	ANTIMICROBIAL LOCKING SOLUTION COMPRISING TAURINAMIDE DERIVATIVE AND BIOLOGICALLY ACCEPTABLE SALT AND ACID, WITH ADDITION OF SMALL CONCENTRATION OF HEPARIN
China	101094679	Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin
Japan	2008518739
Japan	5805617
European Patent Office	1814562	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)