FDA Orange Book · active-ingredient family
Ethinyl estradiol; segesterone acetate
Ethinyl estradiol; segesterone acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ANNOVERA · NDA 209627
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · ring
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANNOVERARLD | MAYNE PHARMA | NDA 209627 | — | Aug 10, 2018 |
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10632066 | Feb 01, 2039 | in 12 yr 10 mo | U-2787 |
| 10780047 | Feb 01, 2039 | in 12 yr 10 mo | U-2787 |
| 10765628 | Feb 01, 2039 | in 12 yr 10 mo | U-2786 |
| 11850251 | Jun 21, 2039 | in 13 yr 2 mo | U-3785 |
| 11529308 | Jun 21, 2039 | in 13 yr 2 mo | Product |
| 10918649 | Jun 21, 2039 | in 13 yr 2 mo | Product |
| 10925882 | Jun 21, 2039 | in 13 yr 2 mo | Product |
| 10940157 | Jun 21, 2039 | in 13 yr 2 mo | Product |
| 12303518 | Jun 21, 2039 | in 13 yr 2 mo | Product |
Ethinyl estradiol; segesterone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
