FDA Orange Book
Is there a generic for Ibsrela?
Ibsrela contains tenapanor. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ibsrela (tenapanor). The Orange Book shows its last listed patent expires November 26, 2042.
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Ibsrela products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 211801, held by ARDELYX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ibsrela patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9408840 | December 30, 2029 | Method of use | U-2626 | 211801 |
| 8969377 | December 30, 2029 | Drug substance, Drug product | None | 211801 |
| 12016856 | December 30, 2029 | Drug substance, Drug product | None | 211801 |
| 9006281 | May 2, 2030 | Method of use | U-2626 | 211801 |
| 8541448 | August 1, 2033 | Drug substance, Drug product | None | 211801 |
| 12539299 | November 26, 2042 | Drug product | None | 211801 |
Ibsrela NDC codes
Questions
Is there a generic for Ibsrela?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ibsrela (tenapanor). The Orange Book shows its last listed patent expires November 26, 2042.
What is the generic name for Ibsrela?
The active ingredient in Ibsrela is tenapanor, per the FDA Orange Book.
When does the Ibsrela patent expire?
The last patent listed for Ibsrela in the Orange Book expires November 26, 2042. 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.