cilastatin sodium; imipenem; relebactam · Msd Merck Co · NDA 212819
Recarbrio
Earliest generic entry, as listed
21 Mar 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8487093, US 8487093, US 8487093.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8487093 | substance, product, use U-2587 | 21 Mar 2033 |
| US 8487093 | substance, product, use U-2840 | 21 Mar 2033 |
| US 8487093 | substance, product, use U-2586 | 21 Mar 2033 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 16 Jul 2029 |
| NPP | new patient population | 9 Dec 2028 |
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 |
|---|---|---|---|
| 212819 · 001 · RLD · discontinued | powder, intravenous | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | 21 Mar 2033 |
Expired or delisted (1)
- NCE · 16 Jul 2024