FDA Orange Book · active-ingredient family
Dienogest; estradiol valerate
Dienogest; estradiol valerate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NATAZIA · NDA 022252
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NATAZIARLD | BAYER HLTHCARE | NDA 022252 | — | May 06, 2010 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071577 | May 13, 2026 | 1 mo ago | ProductU-1 |
| 8153616 | Jan 30, 2028 | in 1 yr 8 mo | U-1240 |
Dienogest; estradiol valerate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
