Orange Book product · Brand (NDA)
ADDYI
FLIBANSERIN
Brand (NDA)NDA 022526RX SPROUT PHARMS
At a glance
Aug 18, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 18, 2015
11 yr ago
Today
Patent 7151103 expires
Listed method-of-use patent (U-1734) expiration.
May 09, 2028
in 1 yr 11 mo
Exclusivity ends · I-983
New indication exclusivity (3 years)
Dec 13, 2028
in 2 yr 6 mo
Pharmaceutical detail
Active ingredient
FLIBANSERIN
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022526
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.
Marketing exclusivity (1)
- I-983New indication exclusivity (3 years)
Dec 13, 2028
in 2 yr 6 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7151103 | May 09, 2028 | in 1 yr 11 mo | U-1734 |
