vancomycin · Hikma · NDA 213895
Vancomycin
Earliest generic entry, as listed
6 Nov 2035
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10039804, US 10188697, US 10849956, US 11000567, US 11517609.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10039804 | product, use U-282 | 6 Nov 2035 |
| US 10188697 | product, use U-282 | 6 Nov 2035 |
| US 10849956 | product | 6 Nov 2035 |
| US 11000567 | product | 6 Nov 2035 |
| US 11517609 | use U-282 | 6 Nov 2035 |
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 |
|---|---|---|---|
| 213895 · 001 · RLD · discontinued | solution, intravenous, oral | 5GM/100ML (50MG/ML) | 6 Nov 2035 |