durlobactam sodium; durlobactam sodium; sulbactam sodium · Entasis Therap · NDA 216974
Xacduro (Copackaged)
Earliest generic entry, as listed
17 Nov 2035
Blocked by patent: US 10376499, US 9968593.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10376499 | product, use U-2840 | 17 Nov 2035 |
| US 9968593 | product, use U-2840 | 17 Nov 2035 |
| US 9309245 | substance | 2 Apr 2033 |
| US 9623014 | use U-2840 | 2 Apr 2033 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 23 May 2033 |
| NCE | new chemical entity (5 years) | 23 May 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 |
|---|---|---|---|
| 216974 · 001 · RLD | powder, intravenous | EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL | 17 Nov 2035 |