heparin sodium; taurolidine · Cormedix · NDA 214520
Defencath
Earliest generic entry, as listed · earliest of 2 marketed strengths
15 Apr 2042
Blocked by patent: US 11738120.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11738120 | drug substance, drug product · sets the listed date | 15 Apr 2042 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 15 Nov 2033 |
| NCE | new chemical entity (5 years) | 15 Nov 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214520 · 001 · RLD | solution, n/a | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | 15 Apr 2042 |
| 214520 · 002 · RLD | solution, n/a | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | 15 Apr 2042 |
Expired or delisted (1)
- US 7696182 · substance, product, use U-3774 · 16 May 2026