Orange Book product · Brand (NDA)
IBSRELA
TENAPANOR HYDROCHLORIDE
At a glance
Sep 12, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2019
6 yr 10 mo ago
Today
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 9408840 expires
Listed method-of-use patent (U-2626) expiration.
Dec 30, 2029
in 3 yr 7 mo
Patent 9006281 expires
Listed method-of-use patent (U-2626) expiration.
May 02, 2030
in 3 yr 11 mo
Patent 8541448 expires
Listed drug substance patent expiration.
Aug 01, 2033
in 7 yr 3 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 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211801
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12016856 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 8969377 | Dec 30, 2029 | in 3 yr 7 mo | SubstanceProduct |
| 9408840 | Dec 30, 2029 | in 3 yr 7 mo | U-2626 |
| 9006281 | May 02, 2030 | in 3 yr 11 mo | U-2626 |
| 8541448 | Aug 01, 2033 | in 7 yr 3 mo | SubstanceProduct |
| 12539299 | Nov 26, 2042 | in 16 yr 8 mo | Product |
