estradiol; norethindrone acetate; relugolix · Sumitomo Pharma Am · NDA 214846
Myfembree
Earliest generic entry, as listed
5 Nov 2042
Blocked by patent: US 12551447.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12551447 | drug product · sets the listed date | 5 Nov 2042 |
| US 11793812 | use U-2360 | 3 May 2038 |
| US 11033551 | use U-3129 | 29 Sep 2037 |
| US 11957684 | use U-3129 | 29 Sep 2037 |
| US 11795178 | drug substance, drug product | 27 Sep 2033 |
| US 12325714 | drug substance, drug product | 27 Sep 2033 |
| US 7300935 | drug substance | 28 Jan 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214846 · 001 · RLD | tablet, oral | 1MG;0.5MG;40MG | 5 Nov 2042 |
Expired or delisted (2)
- US 8058280 · substance, product · 28 Jan 2026
- M-289 · 27 Jan 2026