FDA Orange Book · active-ingredient family
Tenapanor hydrochloride
Tenapanor hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:XPHOZAH · NDA 213931
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
3
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XPHOZAHRLD×3 | ARDELYX INC | NDA 213931 | — | Oct 17, 2023 | |
| IBSRELARLD | ARDELYX INC | NDA 211801 | — | Sep 12, 2019 |
Marketing exclusivity (3)
- NPNew product exclusivity (3 years)
Oct 17, 2026
in 4 mo
- NPNew product exclusivity (3 years)
Oct 17, 2026
in 4 mo
- NPNew product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9408840 | Dec 30, 2029 | in 3 yr 7 mo | U-2626 |
| 8969377 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 12016856 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 9006281 | May 02, 2030 | in 3 yr 11 mo | U-2626 |
| 8541448 | Aug 01, 2033 | in 7 yr 3 mo | SubstanceProduct |
| 10940146 | Apr 10, 2034 | in 7 yr 11 mo | U-381 |
| 10272079 | Apr 10, 2034 | in 7 yr 11 mo | U-381 |
| 12539299 | Nov 26, 2042 | in 16 yr 8 mo | Product |
Tenapanor hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
