Orange Book product · Brand (NDA)
ZULRESSO
BREXANOLONE
At a glance
Jun 17, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2019
7 yr 1 mo ago
Today
Patent 10117951 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9200088 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 10322139 expires
Listed drug product patent expiration.
Jan 23, 2033
in 6 yr 8 mo
Patent 10251894 expires
Listed method-of-use patent (U-2552) expiration.
Nov 27, 2033
in 7 yr 7 mo
Patent 10940156 expires
Listed method-of-use patent (U-2552) expiration.
Mar 08, 2037
in 10 yr 11 mo
Pharmaceutical detail
Active ingredient
BREXANOLONE
Strength
100MG/20ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211371
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10117951 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8410077 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9200088 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9750822 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 10322139 | Jan 23, 2033 | in 6 yr 8 mo | Product |
| 10251894 | Nov 27, 2033 | in 7 yr 7 mo | U-2552 |
| 10940156 | Mar 08, 2037 | in 10 yr 11 mo | U-2552 |
