Viewing data from:

DEFENCATH

NDA

HEPARIN SODIUM; TAUROLIDINE | N214520 | CORMEDIX INC

2 strengths2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Expired (1)Active (1)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

7696182

May. 16, 2026

11738120

Apr. 15, 2042

NCE

Nov. 15, 2028

GAIN

Nov. 15, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Expanded Access Program for Patients at Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials NCT06707480	—	NO_LONGER_AVAILABLE	CorMedix	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2024	SUPPL -3	View Letter (PDF)
Nov 15, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)

RLD

2 patents2 exclusivities▴

SOLUTION;N/A | Approved: Nov 15, 2023

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7696182	May 16, 2026	—	Yes	Yes		—
11738120	Apr 15, 2042	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
GAIN	Nov 15, 2033	Active
NCE	Nov 15, 2028	Active

#002 — 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)

RLD

2 patents2 exclusivities▾

SOLUTION;N/A | Approved: Nov 15, 2023