Orange Book product · Brand (NDA)
OSPHENA
OSPEMIFENE
At a glance
Feb 26, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2013
13 yr 6 mo ago
Today
Patent 8236861 expires
Listed method-of-use patent (U-905) expiration.
Aug 11, 2026
in 2 mo
Patent 8236861 expires
Listed method-of-use patent (U-1369) expiration.
Aug 11, 2026
in 2 mo
Patent 8236861 expires
Listed method-of-use patent (U-1370) expiration.
Aug 11, 2026
in 2 mo
Patent 8642079 expires
Listed drug product patent expiration.
Jul 09, 2028
in 2 yr 1 mo
Pharmaceutical detail
Active ingredient
OSPEMIFENE
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 203505
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 (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8236861 | Aug 11, 2026 | in 2 mo | U-905 |
| 8236861 | Aug 11, 2026 | in 2 mo | U-1369 |
| 8236861 | Aug 11, 2026 | in 2 mo | U-1370 |
| 8642079 | Jul 09, 2028 | in 2 yr 1 mo | Product |
