Orange Book product · Brand (NDA)
QBREXZA
GLYCOPYRRONIUM TOSYLATE
At a glance
Jun 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 2018
8 yr 1 mo ago
Today
Patent 10052267 expires
Listed drug product patent expiration.
Oct 17, 2028
in 2 yr 4 mo
Patent 8618160 expires
Listed drug product patent expiration.
Dec 10, 2029
in 3 yr 6 mo
Patent 9744105 expires
Listed drug product patent expiration.
Jul 18, 2030
in 4 yr 2 mo
Patent 10004717 expires
Listed drug product patent expiration.
Feb 28, 2033
in 6 yr 10 mo
Patent 10543192 expires
Listed drug product patent expiration.
Feb 28, 2033
in 6 yr 10 mo
Patent 10548875 expires
Listed drug substance patent expiration.
Feb 28, 2033
in 6 yr 10 mo
Patent 8859610 expires
Listed drug product patent expiration.
Feb 28, 2033
in 6 yr 10 mo
Patent 9259414 expires
Listed method-of-use patent (U-2398) expiration.
Feb 28, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
GLYCOPYRRONIUM TOSYLATE
Strength
EQ 2.4% BASE
Dosage form
CLOTH
Route
TOPICAL
TE code
Not listed
Application
NDA 210361
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10052267 | Oct 17, 2028 | in 2 yr 4 mo | ProductU-2398 |
| 8618160 | Dec 10, 2029 | in 3 yr 6 mo | ProductU-2398 |
| 9744105 | Jul 18, 2030 | in 4 yr 2 mo | ProductU-2398 |
| 10004717 | Feb 28, 2033 | in 6 yr 10 mo | ProductU-2398 |
| 10543192 | Feb 28, 2033 | in 6 yr 10 mo | Product |
| 10548875 | Feb 28, 2033 | in 6 yr 10 mo | SubstanceProductU-2398 |
| 8859610 | Feb 28, 2033 | in 6 yr 10 mo | ProductU-2398 |
| 9259414 | Feb 28, 2033 | in 6 yr 10 mo | U-2398 |
