amino acids; calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium acetate; sodium glycerophosphate; soybean oil · Fresenius Kabi Usa · NDA 200656
Kabiven In Plastic Container
Earliest generic entry, as listed · earliest of 4 marketed strengths
3 May 2036
Blocked by patent: US 12390398.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12390398 | drug product · sets the listed date | 3 May 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200656 · 004 · RLD | emulsion, intravenous | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) | 3 May 2036 |
| 200656 · 005 · RLD | emulsion, intravenous | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) | 3 May 2036 |
| 200656 · 006 · RLD | emulsion, intravenous | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) | 3 May 2036 |
| 200656 · 007 · RLD | emulsion, intravenous | 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) | 3 May 2036 |