Orange Book product · Brand (NDA)
DAURISMO
GLASDEGIB MALEATE
At a glance
Nov 21, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2018
7 yr 8 mo ago
Today
Patent 8431597 expires
Listed drug product patent expiration.
Jun 29, 2028
in 2 yr 1 mo
Patent 8148401 expires
Listed drug substance patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 10414748 expires
Listed drug substance patent expiration.
Apr 13, 2036
in 10 yr
Patent 11168066 expires
Listed method-of-use patent (U-3254) expiration.
Apr 13, 2036
in 10 yr
Patent 11891372 expires
Listed method-of-use patent (U-3254) expiration.
Apr 13, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
GLASDEGIB MALEATE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 210656
Product number
001
Marketing status
RX
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8431597 | Jun 29, 2028 | in 2 yr 1 mo | Product |
| 8148401 | Nov 21, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 10414748 | Apr 13, 2036 | in 10 yr | SubstanceProduct |
| 11168066 | Apr 13, 2036 | in 10 yr | U-3254 |
| 11891372 | Apr 13, 2036 | in 10 yr | U-3254 |
