fentanyl citrate · Cephalon · NDA 021947
Fentora
Earliest generic entry, as listed · earliest of 6 marketed strengths
15 Jun 2028
1 of 6 marketed strengths has no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7862832, US 7862833.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7862832 | drug product · sets the listed date | 15 Jun 2028 |
| US 7862833 | drug product · sets the listed date | 15 Jun 2028 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021947 · 001 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 15 Jun 2028 |
| 021947 · 002 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 15 Jun 2028 |
| 021947 · 003 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 15 Jun 2028 |
| 021947 · 004 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 15 Jun 2028 |
| 021947 · 005 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 15 Jun 2028 |
| 021947 · 006 · RLD · discontinued | tablet, buccal, sublingual | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |