Orange Book product · Brand (NDA)
DEFINITY RT
PERFLUTREN
At a glance
Nov 17, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 2020
5 yr 8 mo ago
Today
Patent 10022460 expires
Listed drug substance patent expiration.
Dec 28, 2035
in 9 yr 8 mo
Patent 10583207 expires
Listed method-of-use patent (U-665) expiration.
Dec 28, 2035
in 9 yr 8 mo
Patent 11395856 expires
Listed drug substance patent expiration.
Dec 28, 2035
in 9 yr 8 mo
Patent 10583208 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11266750 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11529431 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11857646 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11925695 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 12161730 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 9789210 expires
Listed method-of-use patent (U-665) expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 10588988 expires
Listed method-of-use patent (U-665) expiration.
May 04, 2037
in 11 yr
Pharmaceutical detail
Active ingredient
PERFLUTREN
Strength
13.04MG/2ML (6.52MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021064
Product number
002
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 (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10022460 | Dec 28, 2035 | in 9 yr 8 mo | SubstanceProduct |
| 10583207 | Dec 28, 2035 | in 9 yr 8 mo | U-665 |
| 11395856 | Dec 28, 2035 | in 9 yr 8 mo | SubstanceProductU-665 |
| 10583208 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11266750 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11529431 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11857646 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 11925695 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 12161730 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 9789210 | Mar 16, 2037 | in 10 yr 11 mo | U-665 |
| 10588988 | May 04, 2037 | in 11 yr | U-665 |
