IBSRELA — FDA application NDA211801
Listed sponsor: ARDELYX INC · ARDX company profile · 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 | IBSRELA | TENAPANOR HYDROCHLORIDE | TABLET | ORAL | EQ 50MG BASE | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 12016856 | 001 | listed patent expiry date: 2029-12-30 | drug substance, drug product |
| Patent 8969377 | 001 | listed patent expiry date: 2029-12-30 | drug substance, drug product |
| Patent 9408840 | 001 | listed patent expiry date: 2029-12-30 | U-2626 |
| Patent 9006281 | 001 | listed patent expiry date: 2030-05-02 | U-2626 |
| Patent 8541448 | 001 | listed patent expiry date: 2033-08-01 | drug substance, drug product |
| Patent 12539299 | 001 | listed patent expiry date: 2042-11-26 | drug product |
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 · CHEMBL3301627
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.