tenapanor hydrochloride · Ardelyx Inc · NDA 213931
Xphozah
Earliest generic entry, as listed · earliest of 2 marketed strengths
26 Nov 2042
Blocked by patent: US 12539299.
Listed patents · 6 unexpired
8 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12539299 | drug product · sets the listed date | 26 Nov 2042 |
| US 10272079 | use U-3736, U-381 | 10 Apr 2034 |
| US 10272079 listing row | use U-3736 | 10 Apr 2034 |
| US 10272079 listing row | use U-381 | 10 Apr 2034 |
| US 10940146 | use U-3736, U-381 | 10 Apr 2034 |
| US 10940146 listing row | use U-3736 | 10 Apr 2034 |
| US 10940146 listing row | use U-381 | 10 Apr 2034 |
| US 8541448 | drug substance, drug product | 1 Aug 2033 |
| US 12016856 | drug substance, drug product | 30 Dec 2029 |
| US 8969377 | drug substance, drug product | 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213931 · 001 · RLD · discontinued | tablet, oral | EQ 10MG BASE | 26 Nov 2042 |
| 213931 · 002 · RLD | tablet, oral | EQ 20MG BASE | 26 Nov 2042 |
| 213931 · 003 · RLD | tablet, oral | EQ 30MG BASE | 26 Nov 2042 |
Expired or delisted (1)
- NP · 17 Oct 2026