FDA Orange Book · active-ingredient family
Estradiol; norethindrone acetate; relugolix
Estradiol; norethindrone acetate; relugolix is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MYFEMBREE · NDA 214846
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
1
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYFEMBREERLD | SUMITOMO PHARMA AM | NDA 214846 | — | May 26, 2021 |
Marketing exclusivity (1)
- M-289New use / labeling-change exclusivity (3 years)
Jan 27, 2026
5 mo ago
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8058280 | Jan 28, 2026 | 5 mo ago | SubstanceProduct |
| 7300935 | Jan 28, 2029 | in 2 yr 8 mo | Substance |
| 12325714 | Sep 27, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 11795178 | Sep 27, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 11033551 | Sep 29, 2037 | in 11 yr 5 mo | U-3129 |
| 11957684 | Sep 29, 2037 | in 11 yr 5 mo | U-3129 |
| 11793812 | May 03, 2038 | in 12 yr 1 mo | U-2360 |
| 12551447 | Nov 05, 2042 | in 16 yr 7 mo | Product |
Estradiol; norethindrone acetate; relugolix — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
