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.
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*:
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: | ⤷ Try a Trial | Patent Expiration: | Apr 15, 2042 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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