FDA Orange Book
Is there a generic for Xphozah?
Xphozah 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 Xphozah (tenapanor). The Orange Book shows its last listed patent expires November 26, 2042 and its last listed exclusivity ends October 17, 2026.
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Xphozah products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213931, held by ARDELYX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xphozah patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8969377 | December 30, 2029 | Drug substance, Drug product | None | 213931 |
| 12016856 | December 30, 2029 | Drug substance, Drug product | None | 213931 |
| 8541448 | August 1, 2033 | Drug substance, Drug product | None | 213931 |
| 10940146 | April 10, 2034 | Method of use | U-381 | 213931 |
| 10940146 | April 10, 2034 | Method of use | U-3736 | 213931 |
| 10272079 | April 10, 2034 | Method of use | U-381 | 213931 |
| 10272079 | April 10, 2034 | Method of use | U-3736 | 213931 |
| 12539299 | November 26, 2042 | Drug product | None | 213931 |
Xphozah exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | October 17, 2026 | 213931 |
Xphozah NDC codes
Questions
Is there a generic for Xphozah?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xphozah (tenapanor). The Orange Book shows its last listed patent expires November 26, 2042 and its last listed exclusivity ends October 17, 2026.
What is the generic name for Xphozah?
The active ingredient in Xphozah is tenapanor, per the FDA Orange Book.
When does the Xphozah patent expire?
The last patent listed for Xphozah 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.