Viewing data from:

XPHOZAH

NDA

TENAPANOR HYDROCHLORIDE | N213931 | ARDELYX INC

3 strengths6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Aug. 1, 2033

Dec. 30, 2029

Apr. 10, 2034

Apr. 10, 2034

Dec. 30, 2029

Nov. 26, 2042

Oct. 17, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xphozah (2023)

Total Spending

$1.3M

Total Claims

339

Beneficiaries

318

Avg Cost/Unit

$51.96

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2025	SUPPL -5	View Letter (PDF)
Mar 25, 2025	SUPPL -2	View Letter (PDF)
Oct 18, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 10MG BASE

RLD

6 patents1 exclusivity▴

TABLET;ORAL | Approved: Oct 17, 2023

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8541448	Aug 1, 2033	—	Yes	Yes	—	—
8969377	Dec 30, 2029	—	Yes	Yes	—	—
10272079	Apr 10, 2034	—	—	—		—
10940146	Apr 10, 2034	—	—	—		—
12016856	Dec 30, 2029	—	Yes	Yes	—	—
12539299	Nov 26, 2042	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NP	Oct 17, 2026	< 1 year

#002 — EQ 20MG BASE

RLD

6 patents1 exclusivity▾

TABLET;ORAL | Approved: Oct 17, 2023

#003 — EQ 30MG BASE

RLD

6 patents1 exclusivity▾

TABLET;ORAL | Approved: Oct 17, 2023