elagolix sodium · Abbvie · NDA 210450
Orilissa
Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Aug 2040
Blocked by patent: US 11690845. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
10 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11690845 | use U-3654 · sets the listed date | 27 Aug 2040 |
| US 11542239 | drug substance, drug product | 23 Jul 2039 |
| US 12102637 | drug product | 20 Aug 2038 |
| US 11690854 | use U-3653 | 19 Apr 2038 |
| US 10537572 | use U-2735 | 1 Sep 2036 |
| US 10682351 | use U-2850 | 1 Sep 2036 |
| US 11344551 | use U-3388, U-3389 | 14 Mar 2034 |
| US 11344551 listing row | use U-3388 | 14 Mar 2034 |
| US 11344551 listing row | use U-3389 | 14 Mar 2034 |
| US 11707464 | use U-3672 | 14 Mar 2034 |
| US 7419983 | drug substance, drug product, use U-2360 | 6 Jul 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210450 · 001 · RLD | tablet, oral | EQ 150MG BASE | 27 Aug 2040 |
| 210450 · 002 · RLD | tablet, oral | EQ 200MG BASE | 27 Aug 2040 |