Orange Book product · Brand (NDA)
DEFENCATH
HEPARIN SODIUM; TAUROLIDINE
At a glance
Nov 15, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 15, 2023
2 yr 8 mo ago
Patent 7696182 expires
Listed drug substance patent expiration.
May 16, 2026
1 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Nov 15, 2033
in 7 yr 6 mo
Patent 11738120 expires
Listed drug substance patent expiration.
Apr 15, 2042
in 16 yr 1 mo
Pharmaceutical detail
Active ingredient
HEPARIN SODIUM; TAUROLIDINE
Strength
3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)
Dosage form
SOLUTION
Route
N/A
TE code
Not listed
Application
NDA 214520
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Nov 15, 2028
in 2 yr 5 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Nov 15, 2033
in 7 yr 6 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7696182 | May 16, 2026 | 1 mo ago | SubstanceProductU-3774 |
| 11738120 | Apr 15, 2042 | in 16 yr 1 mo | SubstanceProduct |
