Orange Book product · Brand (NDA)
DSUVIA
SUFENTANIL CITRATE
At a glance
Nov 02, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
21
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2018
7 yr 9 mo ago
Today
Patent 10245228 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 10342762 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 10507180 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8226978 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8231900 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8252328 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8252329 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8535714 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 8778393 expires
Listed method-of-use patent (U-1351) expiration.
Jan 05, 2027
in 7 mo
Patent 8778394 expires
Listed method-of-use patent (U-1351) expiration.
Jan 05, 2027
in 7 mo
Patent 8865211 expires
Listed method-of-use patent (U-1351) expiration.
Jan 05, 2027
in 7 mo
Patent 9320710 expires
Listed method-of-use patent (U-1351) expiration.
Jan 05, 2027
in 7 mo
Patent 9744129 expires
Listed drug product patent expiration.
Jan 05, 2027
in 7 mo
Patent 10896751 expires
Listed drug product patent expiration.
Mar 16, 2030
in 3 yr 10 mo
Patent 11676691 expires
Listed drug product patent expiration.
Mar 16, 2030
in 3 yr 10 mo
Patent 12033733 expires
Listed drug product patent expiration.
Mar 16, 2030
in 3 yr 10 mo
Patent 8574189 expires
Listed drug product patent expiration.
Mar 16, 2030
in 3 yr 10 mo
Patent 8202535 expires
Listed method-of-use patent (U-1351) expiration.
Oct 22, 2030
in 4 yr 5 mo
Patent 8865743 expires
Listed method-of-use patent (U-1351) expiration.
Oct 22, 2030
in 4 yr 5 mo
Patent 8945592 expires
Listed drug product patent expiration.
Jul 29, 2031
in 5 yr 2 mo
Patent 11672738 expires
Listed drug product patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Pharmaceutical detail
Active ingredient
SUFENTANIL CITRATE
Strength
EQ 0.03MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
TE code
Not listed
Application
NDA 209128
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10245228 | Jan 05, 2027 | in 7 mo | ProductU-1351 |
| 10342762 | Jan 05, 2027 | in 7 mo | Product |
| 10507180 | Jan 05, 2027 | in 7 mo | ProductU-1351 |
| 8226978 | Jan 05, 2027 | in 7 mo | ProductU-1351 |
| 8231900 | Jan 05, 2027 | in 7 mo | Product |
| 8252328 | Jan 05, 2027 | in 7 mo | Product |
| 8252329 | Jan 05, 2027 | in 7 mo | Product |
| 8535714 | Jan 05, 2027 | in 7 mo | ProductU-1351 |
| 8778393 | Jan 05, 2027 | in 7 mo | U-1351 |
| 8778394 | Jan 05, 2027 | in 7 mo | U-1351 |
| 8865211 | Jan 05, 2027 | in 7 mo | U-1351 |
| 9320710 | Jan 05, 2027 | in 7 mo | U-1351 |
| 9744129 | Jan 05, 2027 | in 7 mo | Product |
| 10896751 | Mar 16, 2030 | in 3 yr 10 mo | Product |
| 11676691 | Mar 16, 2030 | in 3 yr 10 mo | Product |
| 12033733 | Mar 16, 2030 | in 3 yr 10 mo | Product |
| 8574189 | Mar 16, 2030 | in 3 yr 10 mo | Product |
| 8202535 | Oct 22, 2030 | in 4 yr 5 mo | U-1351 |
| 8865743 | Oct 22, 2030 | in 4 yr 5 mo | U-1351 |
| 8945592 | Jul 29, 2031 | in 5 yr 2 mo | Product |
| 11672738 | Feb 02, 2038 | in 11 yr 10 mo | Product |
