sodium phenylbutyrate · Acer · NDA 214860
Olpruva
Earliest generic entry, as listed · earliest of 8 marketed strengths
17 Oct 2036
Blocked by patent: US 11154521, US 11202767, US 11433041.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11154521 | drug product · sets the listed date | 17 Oct 2036 |
| US 11202767 | use U-3502 · sets the listed date | 17 Oct 2036 |
| US 11433041 | drug product · sets the listed date | 17 Oct 2036 |
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 · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214860 · 001 · RLD | for suspension, oral | 2GM/PACKET | 17 Oct 2036 |
| 214860 · 002 · RLD | for suspension, oral | 3GM/PACKET | 17 Oct 2036 |
| 214860 · 003 · RLD | for suspension, oral | 4GM/PACKET | 17 Oct 2036 |
| 214860 · 004 · RLD | for suspension, oral | 5GM/PACKET | 17 Oct 2036 |
| 214860 · 005 · RLD | for suspension, oral | 6GM/PACKET | 17 Oct 2036 |
| 214860 · 006 · RLD | for suspension, oral | 6.67GM/PACKET | 17 Oct 2036 |
| 214860 · 007 · RLD | for suspension, oral | 0.5GM/PACKET | 17 Oct 2036 |
| 214860 · 008 · RLD | for suspension, oral | 1GM/PACKET | 17 Oct 2036 |