FDA Orange Book · active-ingredient family
Brexanolone
Brexanolone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZULRESSO · NDA 211371
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZULRESSORLD | SAGE THERAP | NDA 211371 | — | Jun 17, 2019 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 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 |
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 10117951 | 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 |
Brexanolone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
