Is there a generic for Sodium zirconium cyclosilicate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Sodium zirconium cyclosilicate, referencing the brand LOKELMA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Sodium zirconium cyclosilicate?

LOKELMA (NDA 207078, ASTRAZENECA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Sodium zirconium cyclosilicate?

The Orange Book lists 14 patents against Sodium zirconium cyclosilicate products, with the earliest listed expiry in 2032. 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.

What dosage forms of Sodium zirconium cyclosilicate are approved?

Sodium zirconium cyclosilicate is approved in the following dosage form: for suspension.

FDA Orange Book · active-ingredient family

Sodium zirconium cyclosilicate

Sodium zirconium cyclosilicate: 1 brand, 1 generic; first approved May 18, 2018; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Feb 10, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 10, 2032

in 5 yr 6 mo

Brand (NDA) products

Originator applications

LOKELMARLD
ASTRAZENECANDA 20707820182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5GM/PACKET FOR SUSPENSION ORAL Rx AB
10GM/PACKET FOR SUSPENSION ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5GM/PACKET	FOR SUSPENSION	ORAL	Rx	AB
10GM/PACKET	FOR SUSPENSION	ORAL	Rx	AB

Generic (ANDA) products (1)

Abbreviated applications

SODIUM ZIRCONIUM CYCLOSILICATE
LUPINANDA 21754920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5GM/PACKET FOR SUSPENSION ORAL Rx AB
10GM/PACKET FOR SUSPENSION ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5GM/PACKET	FOR SUSPENSION	ORAL	Rx	AB
10GM/PACKET	FOR SUSPENSION	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9844567	Feb 10, 2032	in 5 yr 6 mo	U-2312
10398730	Feb 10, 2032	in 5 yr 6 mo	U-2312
9861658	Feb 10, 2032	in 5 yr 6 mo	U-2312
10335432	Feb 10, 2032	in 5 yr 6 mo	U-2312
8808750	Feb 10, 2032	in 5 yr 6 mo	U-2312
11406662	Feb 10, 2032	in 5 yr 6 mo	Substance
10413569	Feb 10, 2032	in 5 yr 6 mo	Substance
8802152	Apr 19, 2032	in 5 yr 8 mo	Substance
9913860	Oct 22, 2033	in 7 yr 2 mo	SubstanceU-2312
8877255	Oct 22, 2033	in 7 yr 2 mo	Substance
10695365	Oct 22, 2033	in 7 yr 2 mo	Substance
9592253	Oct 14, 2035	in 9 yr 2 mo	SubstanceU-2312
10300087	Oct 14, 2035	in 9 yr 2 mo	SubstanceU-2312
11738044	Oct 14, 2035	in 9 yr 2 mo	U-2312

Approval history

FDA approval span

First approval

May 18, 2018

8 yr 6 mo ago

Most recent approval

Aug 07, 2026

1 mo ago

Approvals span 2018–2026 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Sodium zirconium cyclosilicate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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