probenecid; sulopenem etzadroxil · Iterum Therap · NDA 213972
Orlynvah
Earliest generic entry, as listed
23 Dec 2039
Blocked by patent: US 11478428, US 12544337.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11478428 | product, use U-4026 | 23 Dec 2039 |
| US 12544337 | product, use U-4026 | 23 Dec 2039 |
| US 11554112 | use U-4026 | 1 Apr 2039 |
| US 12109197 | use U-4026 | 1 Apr 2039 |
| US 7795243 | substance, product, use U-4026 | 3 Jun 2029 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 25 Oct 2034 |
| NCE | new chemical entity (5 years) | 25 Oct 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 |
|---|---|---|---|
| 213972 · 001 · RLD | tablet, oral | 500MG;500MG | 23 Dec 2039 |