Orange Book product · Brand (NDA)
DEFITELIO
DEFIBROTIDE SODIUM
At a glance
Mar 30, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 30, 2016
10 yr 4 mo ago
Today
Patent 11085043 expires
Listed drug product patent expiration.
Jun 22, 2032
in 6 yr 1 mo
Patent 11236328 expires
Listed method-of-use patent (U-3301) expiration.
Jun 22, 2032
in 6 yr 1 mo
Patent 11746348 expires
Listed drug product patent expiration.
Jun 22, 2032
in 6 yr 1 mo
Patent 12529052 expires
Listed drug product patent expiration.
Jun 22, 2032
in 6 yr 1 mo
Patent 12534722 expires
Listed drug product patent expiration.
Jun 22, 2032
in 6 yr 1 mo
Pharmaceutical detail
Active ingredient
DEFIBROTIDE SODIUM
Strength
200MG/2.5ML (80MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208114
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11085043 | Jun 22, 2032 | in 6 yr 1 mo | Product |
| 11236328 | Jun 22, 2032 | in 6 yr 1 mo | U-3301 |
| 11746348 | Jun 22, 2032 | in 6 yr 1 mo | Product |
| 12529052 | Jun 22, 2032 | in 6 yr 1 mo | Product |
| 12534722 | Jun 22, 2032 | in 6 yr 1 mo | Product |
