cefepime hydrochloride; enmetazobactam · Orchid Pharma · NDA 216165
Exblifep
Earliest generic entry, as listed
7 Nov 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11124526. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11124526 | use U-3852 | 7 Nov 2034 |
| US 7687488 | substance, product, use U-3851 | 3 Dec 2027 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 22 Feb 2034 |
| NCE | new chemical entity (5 years) | 22 Feb 2029 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216165 · 001 · RLD · discontinued | powder, intravenous | EQ 2GM BASE/VIAL;0.5GM/VIAL | 7 Nov 2034 |