ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate · Norgine · NDA 209381
Plenvu
Earliest generic entry, as listed
10 Sep 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10016504, US 10918723, US 12083179, US 8999313, US 9326969, US 9707297.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10016504 | drug product · sets the listed date | 10 Sep 2033 |
| US 10918723 | use U-2310 · sets the listed date | 10 Sep 2033 |
| US 12083179 | drug product, use U-2310 · sets the listed date | 10 Sep 2033 |
| US 8999313 | drug product · sets the listed date | 10 Sep 2033 |
| US 9326969 | use U-2310 · sets the listed date | 10 Sep 2033 |
| US 9707297 | drug product · sets the listed date | 10 Sep 2033 |
| US 9592252 | drug product, use U-2310 | 11 Aug 2032 |
| US 10646512 | drug product | 25 Mar 2032 |
| US 10780112 | drug product | 9 Mar 2032 |
| US 10792306 | drug product, use U-2310 | 9 Mar 2032 |
| US 11529368 | drug product, use U-2310 | 9 Mar 2032 |
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 |
|---|---|---|---|
| 209381 · 001 · RLD · discontinued | for solution, oral | 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | 10 Sep 2033 |