fentanyl citrate · Btcp Pharma · NDA 022569
Lazanda
Earliest generic entry, as listed · earliest of 3 marketed strengths
26 Jan 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9731869.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9731869 | product | 26 Jan 2032 |
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 |
|---|---|---|---|
| 022569 · 001 · RLD · discontinued | spray, metered, nasal | EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Jan 2032 |
| 022569 · 002 · RLD · discontinued | spray, metered, nasal | EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Jan 2032 |
| 022569 · 003 · RLD · discontinued | spray, metered, nasal | EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Jan 2032 |