saxagliptin hydrochloride · Astrazeneca Ab · NDA 022350
Onglyza
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Nov 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7951400.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7951400 | product | 30 Nov 2028 |
Exclusivities · 1 unexpired
| M-14 | miscellaneous (3 years) | 11 Oct 2027 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022350 · 001 · RLD · discontinued | tablet, oral | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 30 Nov 2028 |
| 022350 · 002 · RLD · discontinued | tablet, oral | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 30 Nov 2028 |