Orange Book product · Brand (NDA)
BIJUVA
ESTRADIOL; PROGESTERONE
At a glance
Dec 28, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 28, 2021
4 yr 6 mo ago
Today
Patent 10052386 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 10206932 expires
Listed method-of-use patent (U-2439) expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 10675288 expires
Listed method-of-use patent (U-2439) expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 11033626 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 11166963 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 11793819 expires
Listed method-of-use patent (U-2439) expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 11865179 expires
Listed drug substance patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8633178 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8846648 expires
Listed method-of-use patent (U-2439) expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8846649 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8933059 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8987237 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8993548 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 8993549 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 9114145 expires
Listed method-of-use patent (U-2439) expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 9114146 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Patent 9301920 expires
Listed drug product patent expiration.
Nov 21, 2032
in 6 yr 6 mo
Pharmaceutical detail
Active ingredient
ESTRADIOL; PROGESTERONE
Strength
0.5MG;100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 210132
Product number
002
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 (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10052386 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 10206932 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 10675288 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 11033626 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 11166963 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11793819 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 11865179 | Nov 21, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 8633178 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 8846648 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 8846649 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 8933059 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 8987237 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 8993548 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 8993549 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 9114145 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 9114146 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 9301920 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
