ceftobiprole medocaril sodium · Istx · NDA 218275
Zevtera
Earliest generic entry, as listed
3 Apr 2034
Blocked by exclusivity: GAIN.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 3 Apr 2034 |
| NCE | new chemical entity (5 years) | 3 Apr 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 |
|---|---|---|---|
| 218275 · 001 · RLD | powder, intravenous | 667MG/VIAL | 3 Apr 2034 |