metronidazole · Saptalis Pharms · NDA 216755
Likmez
Earliest generic entry, as listed
4 Oct 2039
Blocked by patent: US 11541035.
Listed patents · 2 unexpired
4 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11541035 | drug product · sets the listed date | 4 Oct 2039 |
| US 12257236 | drug product, use U-3169, U-4163, U-4164 | 16 Jan 2039 |
| US 12257236 listing row | drug product, use U-3169 | 16 Jan 2039 |
| US 12257236 listing row | drug product, use U-4163 | 16 Jan 2039 |
| US 12257236 listing row | drug product, use U-4164 | 16 Jan 2039 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 216755 · 001 · RLD | suspension, oral | 500MG/5ML | 4 Oct 2039 |