# XPHOZAH — FDA application NDA213931

Informational only - not investment advice.

Application NDA213931 · type NDA · FDA status: approved · original approval 2023-10-17

Listed sponsor: ARDELYX INC · [ARDX company profile](/company/ARDX/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET | ORAL | EQ 10MG BASE | Discontinued | not listed | Yes |
| 002 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET | ORAL | EQ 20MG BASE | Prescription | not listed | Yes |
| 003 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET | ORAL | EQ 30MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 12016856, product 001; listed patent expiry date: 2029-12-30.
- Patent 12016856, product 002; listed patent expiry date: 2029-12-30.
- Patent 12016856, product 003; listed patent expiry date: 2029-12-30.
- Patent 8969377, product 001; listed patent expiry date: 2029-12-30.
- Patent 8969377, product 002; listed patent expiry date: 2029-12-30.
- Patent 8969377, product 003; listed patent expiry date: 2029-12-30.
- Patent 8541448, product 001; listed patent expiry date: 2033-08-01.
- Patent 8541448, product 002; listed patent expiry date: 2033-08-01.
- Patent 8541448, product 003; listed patent expiry date: 2033-08-01.
- Patent 10272079, product 001; listed patent expiry date: 2034-04-10.
- Patent 10272079, product 001; listed patent expiry date: 2034-04-10.
- Patent 10272079, product 002; listed patent expiry date: 2034-04-10.
- Patent 10272079, product 002; listed patent expiry date: 2034-04-10.
- Patent 10272079, product 003; listed patent expiry date: 2034-04-10.
- Patent 10272079, product 003; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 001; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 001; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 002; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 002; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 003; listed patent expiry date: 2034-04-10.
- Patent 10940146, product 003; listed patent expiry date: 2034-04-10.
- Patent 12539299, product 001; listed patent expiry date: 2042-11-26.
- Patent 12539299, product 002; listed patent expiry date: 2042-11-26.
- Patent 12539299, product 003; listed patent expiry date: 2042-11-26.
- Exclusivity NP, product 001; listed exclusivity date: 2026-10-17.
- Exclusivity NP, product 002; listed exclusivity date: 2026-10-17.
- Exclusivity NP, product 003; listed exclusivity date: 2026-10-17.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- TENAPANOR HYDROCHLORIDE · UNII 50605O2ZNS · [lmmol compound VFRAXTZDILCRKY-OWRGXFNZSA-N](https://lmmol.com/compound/VFRAXTZDILCRKY-OWRGXFNZSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ARDX/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA213931. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.