tenapanor hydrochloride · Ardelyx Inc · NDA 211801
Ibsrela
Earliest generic entry, as listed
26 Nov 2042
Blocked by patent: US 12539299.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12539299 | drug product · sets the listed date | 26 Nov 2042 |
| US 8541448 | drug substance, drug product | 1 Aug 2033 |
| US 9006281 | use U-2626 | 2 May 2030 |
| US 12016856 | drug substance, drug product | 30 Dec 2029 |
| US 8969377 | drug substance, drug product | 30 Dec 2029 |
| US 9408840 | use U-2626 | 30 Dec 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211801 · 001 · RLD | tablet, oral | EQ 50MG BASE | 26 Nov 2042 |