ranolazine · Spil · NDA 216018
Aspruzyo Sprinkle
Earliest generic entry, as listed · earliest of 2 marketed strengths
24 Jan 2038
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10898444, US 11510878, US 12161761.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10898444 | drug product · sets the listed date | 24 Jan 2038 |
| US 11510878 | drug product · sets the listed date | 24 Jan 2038 |
| US 12161761 | drug product · sets the listed date | 24 Jan 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 |
|---|---|---|---|
| 216018 · 001 · RLD · discontinued | granule, extended release, oral | 500MG | 24 Jan 2038 |
| 216018 · 002 · RLD · discontinued | granule, extended release, oral | 1GM | 24 Jan 2038 |