Orange Book product · Brand (NDA)
XPHOZAH
TENAPANOR HYDROCHLORIDE
At a glance
Oct 17, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 17, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Patent 12016856 expires
Listed drug substance patent expiration.
Dec 30, 2029
in 3 yr 7 mo
Patent 8969377 expires
Listed drug substance patent expiration.
Dec 30, 2029
in 3 yr 7 mo
Patent 8541448 expires
Listed drug substance patent expiration.
Aug 01, 2033
in 7 yr 3 mo
Patent 10272079 expires
Listed method-of-use patent (U-381) expiration.
Apr 10, 2034
in 7 yr 11 mo
Patent 10272079 expires
Listed method-of-use patent (U-3736) expiration.
Apr 10, 2034
in 7 yr 11 mo
Patent 10940146 expires
Listed method-of-use patent (U-381) expiration.
Apr 10, 2034
in 7 yr 11 mo
Patent 10940146 expires
Listed method-of-use patent (U-3736) expiration.
Apr 10, 2034
in 7 yr 11 mo
Patent 12539299 expires
Listed drug product patent expiration.
Nov 26, 2042
in 16 yr 8 mo
Pharmaceutical detail
Active ingredient
TENAPANOR HYDROCHLORIDE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213931
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 17, 2026
in 4 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12016856 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 8969377 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 8541448 | Aug 01, 2033 | in 7 yr 3 mo | SubstanceProduct |
| 10272079 | Apr 10, 2034 | in 7 yr 11 mo | U-381 |
| 10272079 | Apr 10, 2034 | in 7 yr 11 mo | U-3736 |
| 10940146 | Apr 10, 2034 | in 7 yr 11 mo | U-381 |
| 10940146 | Apr 10, 2034 | in 7 yr 11 mo | U-3736 |
| 12539299 | Nov 26, 2042 | in 16 yr 8 mo | Product |
