# DEFENCATH — FDA application NDA214520

Informational only - not investment advice.

Application NDA214520 · type NDA · FDA status: approved · original approval 2023-11-15

Listed sponsor: CORMEDIX · [CRMD company profile](/company/CRMD/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION | N/A | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | Prescription | not listed | Yes |
| 002 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION | N/A | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7696182, product 001; listed patent expiry date: 2026-05-16.
- Patent 7696182, product 002; listed patent expiry date: 2026-05-16.
- Patent 11738120, product 001; listed patent expiry date: 2042-04-15.
- Patent 11738120, product 002; listed patent expiry date: 2042-04-15.
- Exclusivity NCE, product 001; listed exclusivity date: 2028-11-15.
- Exclusivity NCE, product 002; listed exclusivity date: 2028-11-15.
- Exclusivity GAIN, product 001; listed exclusivity date: 2033-11-15.
- Exclusivity GAIN, product 002; listed exclusivity date: 2033-11-15.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- HEPARIN · UNII T2410KM04A · no lmmol compound match
- TAUROLIDINE · UNII 8OBZ1M4V3V · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/CRMD/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA214520. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.