Details for New Drug Application (NDA): 214520

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NDA 214520 describes DEFENCATH, which is a drug marketed by Cormedix and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DEFENCATH profile page.

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.

Summary for 214520

Tradename:	DEFENCATH
Applicant:	Cormedix
Ingredient:	heparin sodium; taurolidine
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 214520

Generic Entry Date for 214520^: ⤷ Sign Up* 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 NDA: 214520

Suppliers and Packaging for NDA: 214520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520	NDA	CorMedix Inc.	72990-103	72990-103-10	10 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;N/A			Strength	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)
Approval Date:	Nov 15, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 15, 2033
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Nov 15, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Apr 15, 2042	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 214520

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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	⤷ Sign Up	⤷ Sign Up
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	⤷ Sign Up	⤷ Sign Up
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-001	Nov 15, 2023	⤷ Sign Up	⤷ Sign Up
Cormedix	DEFENCATH	heparin sodium; taurolidine	SOLUTION;N/A	214520-002	Nov 15, 2023	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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