FDA Orange Book · active-ingredient family
Estradiol; progesterone
Estradiol; progesterone is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BIJUVA · NDA 210132
1
Brand (NDA)
1
Generics (ANDA)
24
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BIJUVARLD×2 | MAYNE PHARMA | NDA 210132 | — | Dec 28, 2021 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESTRADIOL AND PROGESTERONE | AMNEAL PHARMS | ANDA 214293 | — | May 16, 2022 |
Listed patents (24)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11793819 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 11033626 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 10206932 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 9301920 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 9114146 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 9114145 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 8933059 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 8846649 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 8846648 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 10675288 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 8987237 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11166963 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 8993549 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 8633178 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 10052386 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11865179 | Nov 21, 2032 | in 6 yr 6 mo | SubstanceProduct |
| 8993548 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 9006222 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 10806740 | Nov 21, 2032 | in 6 yr 6 mo | ProductU-2439 |
| 11103513 | Nov 21, 2032 | in 6 yr 6 mo | U-2439 |
| 11529360 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 10639375 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11110099 | Nov 21, 2032 | in 6 yr 6 mo | Product |
| 11103516 | Nov 21, 2032 | in 6 yr 6 mo | Product |
Estradiol; progesterone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
