FDA Orange Book · active-ingredient family
Drospirenone; estradiol
Drospirenone; estradiol 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:ANGELIQ · NDA 021355
1
Brand (NDA)
1
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANGELIQRLD×2 | BAYER HLTHCARE | NDA 021355 | — | Feb 29, 2012 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DROSPIRENONE AND ESTRADIOL | NOVAST LABS | ANDA 218031 | AB | Oct 28, 2025 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8906890 | Oct 22, 2031 | in 5 yr 5 mo | Product |
Drospirenone; estradiol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
