FDA Orange Book · active-ingredient family
Sodium zirconium cyclosilicate
Sodium zirconium cyclosilicate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:LOKELMA · NDA 207078
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOKELMARLD×2 | ASTRAZENECA | NDA 207078 | — | May 18, 2018 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9844567 | Feb 10, 2032 | in 5 yr 9 mo | U-2312 |
| 10398730 | Feb 10, 2032 | in 5 yr 9 mo | U-2312 |
| 9861658 | Feb 10, 2032 | in 5 yr 9 mo | U-2312 |
| 10335432 | Feb 10, 2032 | in 5 yr 9 mo | U-2312 |
| 8808750 | Feb 10, 2032 | in 5 yr 9 mo | U-2312 |
| 11406662 | Feb 10, 2032 | in 5 yr 9 mo | Substance |
| 10413569 | Feb 10, 2032 | in 5 yr 9 mo | Substance |
| 8802152 | Apr 19, 2032 | in 5 yr 11 mo | Substance |
| 9913860 | Oct 22, 2033 | in 7 yr 5 mo | SubstanceU-2312 |
| 8877255 | Oct 22, 2033 | in 7 yr 5 mo | Substance |
| 10695365 | Oct 22, 2033 | in 7 yr 5 mo | Substance |
| 9592253 | Oct 14, 2035 | in 9 yr 5 mo | SubstanceU-2312 |
| 10300087 | Oct 14, 2035 | in 9 yr 5 mo | SubstanceU-2312 |
| 11738044 | Oct 14, 2035 | in 9 yr 5 mo | U-2312 |
Sodium zirconium cyclosilicate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
