Orange Book product · Brand (NDA)
MYFEMBREE
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
At a glance
May 26, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2021
5 yr 2 mo ago
Exclusivity ends · M-289
New use / labeling-change exclusivity (3 years)
Jan 27, 2026
5 mo ago
Patent 8058280 expires
Listed drug substance patent expiration.
Jan 28, 2026
5 mo ago
Today
Patent 7300935 expires
Listed drug substance patent expiration.
Jan 28, 2029
in 2 yr 8 mo
Patent 11795178 expires
Listed drug substance patent expiration.
Sep 27, 2033
in 7 yr 5 mo
Patent 12325714 expires
Listed drug substance patent expiration.
Sep 27, 2033
in 7 yr 5 mo
Patent 11033551 expires
Listed method-of-use patent (U-3129) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 11957684 expires
Listed method-of-use patent (U-3129) expiration.
Sep 29, 2037
in 11 yr 5 mo
Patent 11793812 expires
Listed method-of-use patent (U-2360) expiration.
May 03, 2038
in 12 yr 1 mo
Patent 12551447 expires
Listed drug product patent expiration.
Nov 05, 2042
in 16 yr 7 mo
Pharmaceutical detail
Active ingredient
ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Strength
1MG;0.5MG;40MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214846
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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 |
| 11795178 | Sep 27, 2033 | in 7 yr 5 mo | SubstanceProduct |
| 12325714 | 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 |
