fentanyl citrate · Adalvo · NDA 022266
Onsolis
Earliest generic entry, as listed · earliest of 5 marketed strengths
23 Jul 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9597288.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9597288 | drug product, use U-767 · sets the listed date | 23 Jul 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 · 022266-005Listed date 23 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 022266-004Listed date 23 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 022266-003Listed date 23 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 022266-002Listed date 23 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 022266-001Listed date 23 Jul 2027Detected 24 Oct 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022266 · 001 · discontinued | film, buccal | EQ 0.2MG BASE | 23 Jul 2027 |
| 022266 · 002 · discontinued | film, buccal | EQ 0.4MG BASE | 23 Jul 2027 |
| 022266 · 003 · discontinued | film, buccal | EQ 0.6MG BASE | 23 Jul 2027 |
| 022266 · 004 · discontinued | film, buccal | EQ 0.8MG BASE | 23 Jul 2027 |
| 022266 · 005 · discontinued | film, buccal | EQ 1.2MG BASE | 23 Jul 2027 |