Skip to content

Drybench Patent.

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC, NDA 212832

The patents and exclusivities FDA's Orange Book lists for NDA 212832 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026
Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app

Listed protection

Listed dates run from 12 Oct 2041 to 12 Oct 2041, each by its own rule; no one date stands for this product.

Earliest listed date
12 Oct 2041US 11,813,291, product and use patentRule R1 · Products 004, 005
Source lines

patent.txt lines 14,433, 14,435

Latest listed date
12 Oct 2041US 11,925,661, product and use patentRule R1 · Products 004, 005
Source lines

patent.txt lines 14,434, 14,436

Latest substance patent
None listed
Latest listed patent
12 Oct 2041US 11,925,661, product and use patentRule R1 · Products 004, 005
Source lines

patent.txt lines 14,434, 14,436

Latest exclusivity
None listed

Listed dates of other NDAs in the same years:2041

4 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 212832, as listed. The sections below name products by these numbers.

  • Product 001 · POTASSIUM PHOSPHATES

    Dosage form; route
    SOLUTION;INTRAVENOUS
    Strength
    1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)
    Approval date as listed
    26 Nov 2019
    Type as listed
    RX
    Applicant as listed
    FRESENIUS KABI USA LLC
  • Product 002 · POTASSIUM PHOSPHATES

    Dosage form; route
    SOLUTION;INTRAVENOUS
    Strength
    3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
    Approval date as listed
    26 Nov 2019
    Type as listed
    RX
    Applicant as listed
    FRESENIUS KABI USA LLC
  • Product 003 · POTASSIUM PHOSPHATES

    Dosage form; route
    SOLUTION;INTRAVENOUS
    Strength
    11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)
    Approval date as listed
    26 Nov 2019
    Type as listed
    RX
    Applicant as listed
    FRESENIUS KABI USA LLC
  • Product 004 · POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE

    Dosage form; route
    SOLUTION;INTRAVENOUS
    Strength
    1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)
    Approval date as listed
    9 May 2025
    Type as listed
    RX
    Applicant as listed
    FRESENIUS KABI USA LLC
  • Product 005 · POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE

    Dosage form; route
    SOLUTION;INTRAVENOUS
    Strength
    1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)
    Approval date as listed
    9 May 2025
    Type as listed
    RX
    Applicant as listed
    FRESENIUS KABI USA LLC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

2 entries from 4 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 11,813,291, product and use patent

    patent.txt lines 14,433, 14,435
    Expiry as listed
    12 Oct 2041
    Rule
    R1
    Flags
    product · use code U-4185
    Product numbers
    004, 005
  • US 11,925,661, product and use patent

    patent.txt lines 14,434, 14,436
    Expiry as listed
    12 Oct 2041
    Rule
    R1
    Flags
    product · use code U-4185
    Product numbers
    004, 005

Listed exclusivities

Each exclusivity FDA lists for NDA 212832, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 212832.

Paragraph IV list rows giving NDA 212832

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212832, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 212832 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

Notes from the trace

  • R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week