ibuprofen · Apotex · NDA 022348
Caldolor
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Mar 2032
Blocked by patent: US 11806400, US 9072661, US 9072710. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11806400 | use U-3746 · sets the listed date | 16 Mar 2032 |
| US 9072661 | use U-2264 · sets the listed date | 16 Mar 2032 |
| US 9072710 | use U-2266 · sets the listed date | 16 Mar 2032 |
| US 9012508 | use U-981 | 14 Sep 2030 |
| US 8735452 | use U-981 | 30 Sep 2029 |
| US 8871810 | use U-981 | 30 Sep 2029 |
| US 9114068 | use U-1735 | 30 Sep 2029 |
| US 9138404 | use U-1756 | 30 Sep 2029 |
| US 9295639 | use U-1756 | 30 Sep 2029 |
| US 9649284 | use U-2018 | 30 Sep 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022348 · 001 · discontinued | solution, intravenous | 400MG/4ML (100MG/ML) | open |
| 022348 · 002 · RLD | solution, intravenous | 800MG/8ML (100MG/ML) | 16 Mar 2032 |
| 022348 · 003 · RLD | solution, intravenous | 800MG/200ML (4MG/ML) | 16 Mar 2032 |
Expired or delisted (1)
- NPP · 11 May 2026