FDA Orange Book · active-ingredient family
Potassium phosphate, dibasic; potassium phosphate, monobasic
Potassium phosphate, dibasic; potassium phosphate, monobasic is approved as 3 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE · NDA 218343
3
Brand (NDA)
6
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDERLD | AMNEAL | NDA 218343 | — | Jul 26, 2024 | |
| POTASSIUM PHOSPHATESRLD×5 | FRESENIUS KABI USA | NDA 212832 | AP | Nov 26, 2019 | |
| POTASSIUM PHOSPHATESRLD | CMP DEV LLC | NDA 212121 | — | Sep 19, 2019 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM PHOSPHATES×3 | CAPLIN | ANDA 220373 | AP | Mar 12, 2026 | |
| POTASSIUM PHOSPHATES | HOSPIRA | ANDA 217459 | AP | Sep 11, 2025 | |
| POTASSIUM PHOSPHATES×3 | CIPLA | ANDA 217892 | AP | Jan 24, 2025 | |
| POTASSIUM PHOSPHATES×2 | SOMERSET THERAPS LLC | ANDA 217726 | AP | Jul 11, 2024 | |
| POTASSIUM PHOSPHATES×3 | AMNEAL | ANDA 216344 | AP | Oct 10, 2023 | |
| POTASSIUM PHOSPHATES×3 | AM REGENT | ANDA 216274 | AP | Oct 02, 2023 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10632150 | Apr 19, 2039 | in 13 yr | ProductU-2789 |
| 11925661 | Oct 12, 2041 | in 15 yr 6 mo | ProductU-4185 |
| 11813291 | Oct 12, 2041 | in 15 yr 6 mo | ProductU-4185 |
Potassium phosphate, dibasic; potassium phosphate, monobasic — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
