FDA Orange Book
Generic for Kayexalate
Kayexalate contains sodium polystyrene sulfonate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Kayexalate is sodium polystyrene sulfonate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Kayexalate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral, rectal | 453.6GM/BOT | Discontinued | None | 2 | AA |
NDA 011287, held by CONCORDIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium polystyrene sulfonate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| UPSHER SMITH LABORATORIES LLC | 090313 | AA (A-rated, therapeutically equivalent) | December 21, 2011 | 453.6GM/BOT |
| EPIC PHARMA LLC | 202333 | AA (A-rated, therapeutically equivalent) | March 19, 2014 | 453.6GM/BOT |
Questions
Is there a generic for Kayexalate?
Yes. The generic name for Kayexalate is sodium polystyrene sulfonate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Kayexalate?
The active ingredient in Kayexalate is sodium polystyrene sulfonate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.