fenofibric acid · Rosemount · NDA 022418
Fibricor
Earliest generic entry, as listed · earliest of 2 marketed strengths
20 Aug 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7569612, US 7741373, US 7741374, US 7915247. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
7 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7569612 | use U-1000 · sets the listed date | 20 Aug 2027 |
| US 7741373 | use U-1059 · sets the listed date | 20 Aug 2027 |
| US 7741374 | use U-1060, U-1061 | 20 Aug 2027 |
| US 7741374 listing row | use U-1060 · sets the listed date | 20 Aug 2027 |
| US 7741374 listing row | use U-1061 · sets the listed date | 20 Aug 2027 |
| US 7915247 | use U-1000, U-1059, U-1061 | 20 Aug 2027 |
| US 7915247 listing row | use U-1000 · sets the listed date | 20 Aug 2027 |
| US 7915247 listing row | use U-1059 · sets the listed date | 20 Aug 2027 |
| US 7915247 listing row | use U-1061 · sets the listed date | 20 Aug 2027 |
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
- Enters 12-month window basis: patent, carve-out possible · 022418-002Listed date 20 Aug 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent, carve-out possible · 022418-001Listed date 20 Aug 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022418 · 001 · RLD · discontinued | tablet, oral | 35MG | 20 Aug 2027 |
| 022418 · 002 · RLD · discontinued | tablet, oral | 105MG | 20 Aug 2027 |