FDA Orange Book
Is there a generic for Myfembree?
Myfembree contains relugolix, estradiol and norethindrone acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Myfembree (relugolix, estradiol and norethindrone acetate). The Orange Book shows its last listed patent expires November 5, 2042 and its last listed exclusivity ends January 27, 2026.
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Myfembree products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG;0.5MG;40MG | Marketed (Rx) | None | 0 | None |
NDA 214846, held by SUMITOMO PHARMA AMERICA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Myfembree patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8058280 | January 28, 2026 | Drug substance, Drug product | None | 214846 |
| 7300935 | January 28, 2029 | Drug substance | None | 214846 |
| 12325714 | September 27, 2033 | Drug substance, Drug product | None | 214846 |
| 11795178 | September 27, 2033 | Drug substance, Drug product | None | 214846 |
| 11033551 | September 29, 2037 | Method of use | U-3129 | 214846 |
| 11957684 | September 29, 2037 | Method of use | U-3129 | 214846 |
| 11793812 | May 3, 2038 | Method of use | U-2360 | 214846 |
| 12551447 | November 5, 2042 | Drug product | None | 214846 |
Myfembree exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-289 | Miscellaneous | January 27, 2026 | 214846 |
Myfembree NDC codes
Questions
Is there a generic for Myfembree?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Myfembree (relugolix, estradiol and norethindrone acetate). The Orange Book shows its last listed patent expires November 5, 2042 and its last listed exclusivity ends January 27, 2026.
What is the generic name for Myfembree?
The active ingredient in Myfembree is relugolix, estradiol and norethindrone acetate, per the FDA Orange Book.
When does the Myfembree patent expire?
The last patent listed for Myfembree in the Orange Book expires November 5, 2042. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.