potassium phosphate, dibasic; potassium phosphate, monobasic · Fresenius Kabi Usa · NDA 212121, 212832
Potassium Phosphates
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10632150 | drug product, use U-2789 | 19 Apr 2039 |
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
- Generic approved · ANDA 220373, Caplin · 212121-001Approved 12 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212121 · 001 · RLD · discontinued | solution, intravenous | 4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML) | 19 Apr 2039 |
| 212832 · 001 · RLD | solution, intravenous | 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) | open |
| 212832 · 002 · RLD | solution, intravenous | 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) | open |
| 212832 · 003 · RLD | solution, intravenous | 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) | open |