nimodipine · Azurity · NDA 203340
Nymalize
Earliest generic entry, as listed
16 Apr 2038
Blocked by patent: US 10342787, US 10576070, US 11207306, US 11413277, US 11806338, US 12186308.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10342787 | drug product, use U-2804 · sets the listed date | 16 Apr 2038 |
| US 10576070 | drug product, use U-2804 · sets the listed date | 16 Apr 2038 |
| US 11207306 | use U-2804 · sets the listed date | 16 Apr 2038 |
| US 11413277 | drug product, use U-2804 · sets the listed date | 16 Apr 2038 |
| US 11806338 | drug product · sets the listed date | 16 Apr 2038 |
| US 12186308 | drug product, use U-2804 · sets the listed date | 16 Apr 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203340 · 001 · RLD · discontinued | solution, oral | 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 203340 · 002 · RLD | solution, oral | 6MG/ML | 16 Apr 2038 |