relugolix · Sumitomo Pharma Am · NDA 214621
Orgovyx
Earliest generic entry, as listed
29 Sep 2037
Blocked by patent: US 10449191, US 10786501, US 11583526, US 12097198, US 12144809, US 12336990, US 12629370. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10449191 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 10786501 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 11583526 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 12097198 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 12144809 | use U-4035 · sets the listed date | 29 Sep 2037 |
| US 12336990 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 12629370 | use U-3020 · sets the listed date | 29 Sep 2037 |
| US 10350170 | drug product | 25 Feb 2036 |
| 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
- 25 Oct 2026Generic tentatively approved · 214621-0012 Sep 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214621 · 001 · RLD | tablet, oral | 120MG | 29 Sep 2037 |
Expired or delisted (1)
- US 8058280 · substance, product · 28 Jan 2026