Is there a generic for Potassium phosphate, dibasic; potassium phosphate, monobasic?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Potassium phosphate, dibasic; potassium phosphate, monobasic, referencing the brand POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Potassium phosphate, dibasic; potassium phosphate, monobasic?

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE (NDA 218343, AMNEAL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Potassium phosphate, dibasic; potassium phosphate, monobasic?

The Orange Book lists 3 patents against Potassium phosphate, dibasic; potassium phosphate, monobasic products, with the earliest listed expiry in 2039. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

FDA Orange Book · active-ingredient family

Potassium phosphate, dibasic; potassium phosphate, monobasic

Potassium phosphate, dibasic; potassium phosphate, monobasic: 3 brands, 6 generics; first approved Sep 19, 2019; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 6 ANDA applications approved.

Earliest patent expiry Apr 19, 2039

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 19, 2039

in 13 yr

Originator applications

Brand (NDA) products

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDERLDRS

AMNEALNDA 2183432024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

POTASSIUM PHOSPHATESRLDRS

FRESENIUS KABI USANDA 21283220195 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)	SOLUTION	INTRAVENOUS	Rx	—
1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)	SOLUTION	INTRAVENOUS	Rx	—

POTASSIUM PHOSPHATESRLD

CMP DEV LLCNDA 2121212019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)	SOLUTION	INTRAVENOUS	Discontinued	—

Abbreviated applications

Generic (ANDA) products (6)

POTASSIUM PHOSPHATES

CAPLINANDA 22037320263 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

POTASSIUM PHOSPHATES

HOSPIRAANDA 2174592025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

POTASSIUM PHOSPHATES

CIPLAANDA 21789220253 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

POTASSIUM PHOSPHATES

SOMERSET THERAPS LLCANDA 21772620242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

POTASSIUM PHOSPHATES

AMNEALANDA 21634420233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

POTASSIUM PHOSPHATES

AM REGENTANDA 21627420233 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
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

FDA approval span

Approval history

First approval

Sep 19, 2019

6 yr 11 mo ago

Most recent approval

Mar 12, 2026

4 mo ago

Approvals span 2019–2026 across 9 FDA applications.

Brand (NDA) 333%

Generic (ANDA) 667%