FDA Orange Book
Generic for Lokelma
Lokelma contains sodium zirconium cyclosilicate. 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 Lokelma is sodium zirconium cyclosilicate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lokelma products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 10GM/PACKET | Marketed (Rx) | AB | 1 | AB |
| for suspension, oral | 5GM/PACKET | Marketed (Rx) | AB | 1 | AB |
NDA 207078, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium zirconium cyclosilicate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 217549 | AB (A-rated, therapeutically equivalent) | August 7, 2026 | 10GM/PACKET, 5GM/PACKET |
Lokelma patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9844567 | February 10, 2032 | Method of use | U-2312 | 207078 |
| 10398730 | February 10, 2032 | Method of use | U-2312 | 207078 |
| 9861658 | February 10, 2032 | Method of use | U-2312 | 207078 |
| 10335432 | February 10, 2032 | Method of use | U-2312 | 207078 |
| 8808750 | February 10, 2032 | Method of use | U-2312 | 207078 |
| 11406662 | February 10, 2032 | Drug substance | None | 207078 |
| 10413569 | February 10, 2032 | Drug substance | None | 207078 |
| 8802152 | April 19, 2032 | Drug substance | None | 207078 |
| 9913860 | October 22, 2033 | Drug substance | U-2312 | 207078 |
| 8877255 | October 22, 2033 | Drug substance | None | 207078 |
| 10695365 | October 22, 2033 | Drug substance | None | 207078 |
| 9592253 | October 14, 2035 | Drug substance | U-2312 | 207078 |
| 10300087 | October 14, 2035 | Drug substance | U-2312 | 207078 |
| 11738044 | October 14, 2035 | Method of use | U-2312 | 207078 |
Lokelma NDC codes
Questions
Is there a generic for Lokelma?
Yes. The generic name for Lokelma is sodium zirconium cyclosilicate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lokelma?
The active ingredient in Lokelma is sodium zirconium cyclosilicate, per the FDA Orange Book.
When does the Lokelma patent expire?
The last patent listed for Lokelma in the Orange Book expires October 14, 2035. A listed patent expiry date is not a generic launch date.
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.