Viewing data from:

FILSPARI

NDA

SPARSENTAN | N216403 | TRAVERE THERAPEUTICS INC

2 strengths2 unique patents3 unique exclusivities

Patent Timeline

2 unique patents, 3 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

Today

9662312

Mar. 29, 2030

9993461

Mar. 29, 2030

NCE

Feb. 17, 2028

ODE-389

Feb. 17, 2030

ODE-493

Sep. 5, 2031

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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis NCT07219121	Phase 4	Active	Travere Therapeutics, Inc.	20	2025-10-07 → 2027-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Filspari (2023)

Total Spending

$4.8M

Total Claims

426

Beneficiaries

112

Avg Cost/Unit

$344.82

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LIFE SCIENCES PRIVATE LTDSPARSENTAN

DMF 414982025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 15, 2026	SUPPL -6	View Letter (PDF)
Aug 29, 2025	SUPPL -5	View Letter (PDF)
Sep 6, 2024	SUPPL -3	View Letter (PDF)
Oct 19, 2023	SUPPL -2	View Letter (PDF)
Feb 21, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG

RLD

2 patents3 exclusivities▴

TABLET;ORAL | Approved: Feb 17, 2023

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9662312	Mar 29, 2030	—	—	—	U-4495	—
9993461	Mar 29, 2030	—	—	—		—

Exclusivities (3)

Code	Date	Status
NCE	Feb 17, 2028	Active
ODE-389	Feb 17, 2030	Active
ODE-493	Sep 5, 2031	Active

#002 — 400MG

RLD

2 patents3 exclusivities▾

TABLET;ORAL | Approved: Feb 17, 2023

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Travere added U.S. Patent 9,662,312 to the Orange Book for Filspari (sparsentan) NDA 216403.

New: New record

ADDED7/1/2026

Travere added U.S. Patent 9,662,312 to the Orange Book listing for Filspari (sparsentan), NDA 216403.

New: New record