FDA Orange Book · active-ingredient family
Estradiol valerate
Estradiol valerate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DELESTROGEN · NDA 009402
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DELESTROGENRLD×3 | PH HEALTH | NDA 009402 | AO | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESTRADIOL VALERATE×3 | XIROMED | ANDA 216656 | AO | Apr 28, 2023 | |
| ESTRADIOL VALERATE×3 | HIKMA | ANDA 203723 | AO | Apr 21, 2020 | |
| ESTRADIOL VALERATE×2 | AM REGENT | ANDA 090920 | AO | Jan 19, 2010 | |
| ESTRADIOL VALERATE×3 | FOSUN PHARMA | ANDA 040628 | — | Oct 04, 2007 | |
| ESTRADIOL VALERATE | DR REDDYS | ANDA 083547 | — | Approved Prior to Jan 1, 1982 | |
| ESTRADIOL VALERATE | DR REDDYS | ANDA 083714 | — | Approved Prior to Jan 1, 1982 | |
| ESTRADIOL VALERATE | WATSON LABS | ANDA 083546 | — | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Estradiol valerate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
