fenofibrate · Lupin · NDA 021695
Antara (Micronized)
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9314447 | drug product, use U-1447, U-1448 | 31 May 2033 |
| US 9314447 listing row | drug product, use U-1447 | 31 May 2033 |
| US 9314447 listing row | drug product, use U-1448 | 31 May 2033 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021695 · 001 · RLD | capsule, oral | 43MG | open |
| 021695 · 002 · discontinued | capsule, oral | 87MG | open |
| 021695 · 003 · RLD | capsule, oral | 130MG | open |
| 021695 · 004 · RLD · discontinued | capsule, oral | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021695 · 005 · RLD · discontinued | capsule, oral | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 31 May 2033 |