glycopyrrolate; neostigmine methylsulfate · Azurity · NDA 216903
Prevduo
Earliest generic entry, as listed
25 Oct 2038
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10456354, US 11110054, US 11938217, US 12151020, US 12383491.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10456354 | product | 25 Oct 2038 |
| US 11110054 | product | 25 Oct 2038 |
| US 11938217 | product | 25 Oct 2038 |
| US 12151020 | product | 25 Oct 2038 |
| US 12383491 | product | 25 Oct 2038 |
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 |
|---|---|---|---|
| 216903 · 001 · RLD · discontinued | solution, intravenous | 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) | 25 Oct 2038 |