FDA Orange Book · active-ingredient family
Sodium polystyrene sulfonate
Sodium polystyrene sulfonate is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KAYEXALATE · NDA 011287
1
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KAYEXALATERLD | CONCORDIA | NDA 011287 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM POLYSTYRENE SULFONATE | LYNE | ANDA 214912 | AA | Jun 10, 2025 | |
| SODIUM POLYSTYRENE SULFONATE | AJENAT PHARMS | ANDA 205727 | AA | Feb 23, 2016 | |
| SODIUM POLYSTYRENE SULFONATE | CHARTWELL RX | ANDA 206815 | AA | Feb 18, 2016 | |
| KALEXATE×2 | KVK TECH | ANDA 040905 | — | Apr 03, 2015 | |
| SODIUM POLYSTYRENE SULFONATE×2 | NUVO PHARMS INC | ANDA 204071 | — | Nov 28, 2014 | |
| SODIUM POLYSTYRENE SULFONATE | EPIC PHARMA LLC | ANDA 202333 | AA | Mar 19, 2014 | |
| SODIUM POLYSTYRENE SULFONATE | UPSHER SMITH LABS | ANDA 090313 | AA | Dec 21, 2011 | |
| SODIUM POLYSTYRENE SULFONATE | ANI PHARMS | ANDA 090590 | — | May 13, 2011 | |
| SODIUM POLYSTYRENE SULFONATE | CITRUSPHRMA | ANDA 040909 | — | Dec 03, 2008 | |
| KIONEX | ANI PHARMS | ANDA 040028 | AA | Sep 17, 2007 | |
| KIONEX | ANI PHARMS | ANDA 040029 | AA | Feb 06, 1998 | |
| SODIUM POLYSTYRENE SULFONATE | CMP PHARMA INC | ANDA 089910 | AA | Jan 19, 1989 | |
| SODIUM POLYSTYRENE SULFONATE | HIKMA | ANDA 089049 | — | Nov 17, 1986 | |
| SODIUM POLYSTYRENE SULFONATERLD | PAI HOLDINGS PHARM | ANDA 088786 | — | Sep 11, 1984 | |
| SODIUM POLYSTYRENE SULFONATE | MORTON GROVE | ANDA 088717 | — | Sep 11, 1984 | |
| SODIUM POLYSTYRENE SULFONATE | ROXANE | ANDA 088453 | — | Nov 17, 1983 | |
| SPSRLD | CMP PHARMA INC | ANDA 087859 | AA | Dec 08, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Sodium polystyrene sulfonate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
