meropenem; vaborbactam · Rempex · NDA 209776
Vabomere
Earliest generic entry, as listed
6 Apr 2039
Blocked by patent: US 11376237, US 12533342. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11376237 | use U-3421 · sets the listed date | 6 Apr 2039 |
| US 12533342 | use U-3421 · sets the listed date | 6 Apr 2039 |
| US 12478606 | use U-3421 | 8 Jan 2038 |
| US 8680136 | drug substance, drug product | 29 Aug 2031 |
| US 10172874 | drug product | 8 Aug 2031 |
| US 10183034 | use U-2490 | 8 Aug 2031 |
| US 10561675 | use U-2490 | 8 Aug 2031 |
| US 11007206 | use U-3128 | 8 Aug 2031 |
| US 12171772 | drug substance | 8 Aug 2031 |
| US 9694025 | use U-2120 | 8 Aug 2031 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 29 Aug 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209776 · 001 · RLD | powder, intravenous | 1GM/VIAL;1GM/VIAL | 6 Apr 2039 |
Expired or delisted (1)
- NCE · 29 Aug 2022