cefepime hydrochloride; zidebactam · Wockhardt Bio Ag · NDA 220787
Zaynich
Earliest generic entry, as listed
29 May 2036
Blocked by exclusivity: GAIN.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9657021 | drug substance | 12 Oct 2033 |
| US 9834557 | drug substance | 12 Oct 2033 |
| US 8822450 | drug substance, drug product | 24 Aug 2032 |
| US 8853197 | drug substance | 24 Aug 2032 |
| US 9132133 | use U-4558 | 24 Aug 2032 |
| US 9381200 | drug product | 24 Aug 2032 |
| US 9827235 | drug product, use U-4558 | 24 Aug 2032 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 29 May 2036 |
| NCE | new chemical entity (5 years) | 29 May 2031 |
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 |
|---|---|---|---|
| 220787 · 001 · RLD | powder, intravenous | EQ 2GM BASE/VIAL;1GM/VIAL | 29 May 2036 |