FDA Orange Book
Is there a generic for Defencath?
Defencath contains taurolidine and heparin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Defencath (taurolidine and heparin). The Orange Book shows its last listed patent expires April 15, 2042 and its last listed exclusivity ends November 15, 2033.
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Defencath products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, n/a | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, n/a | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 214520, held by CORMEDIX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Defencath patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7696182 | May 16, 2026 | Drug substance, Drug product | U-3774 | 214520 |
| 11738120 | April 15, 2042 | Drug substance, Drug product | None | 214520 |
Defencath exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 15, 2028 | 214520 |
| GAIN | Generating Antibiotic Incentives Now | November 15, 2033 | 214520 |
Defencath NDC codes
Questions
Is there a generic for Defencath?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Defencath (taurolidine and heparin). The Orange Book shows its last listed patent expires April 15, 2042 and its last listed exclusivity ends November 15, 2033.
What is the generic name for Defencath?
The active ingredient in Defencath is taurolidine and heparin, per the FDA Orange Book.
When does the Defencath patent expire?
The last patent listed for Defencath in the Orange Book expires April 15, 2042. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.