Viewing data from:

FILSPARI

NDA

SPARSENTAN | N216403 | TRAVERE THERAPEUTICS INC

2 strengths2 unique patents4 unique exclusivities

Patent Timeline

2 unique patents, 4 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

I-989

Apr. 13, 2029

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

6 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 2 completed

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
ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)NCT05630612	Phase 2	Active	University of Edinburgh	32	2022-12-08 → 2027-09-01
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy NCT03762850	Phase 3	Active	Travere Therapeutics, Inc.	406	2018-12-11 → 2026-07
Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria NCT07224776	Phase 1	Recruiting	Brigham and Women's Hospital	20	2026-07-10 → 2028-12-01
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis NCT01613118	Phase 2	Completed	Travere Therapeutics, Inc.	109	2014-03 → 2024-03-25
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)NCT03493685	Phase 3	Completed	Travere Therapeutics, Inc.	371	2018-04-17 → 2026-03-19

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$7933.29

Highest Price

$10778.91

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68974-0200-30FILSPARI 200MG TAB	$7945.06	Big4	Travere Therapeutics, Inc.	09/14/2026
68974-0200-30FILSPARI 200MG TAB	$10778.91	FSS	Travere Therapeutics, Inc.	09/14/2026
68974-0400-30FILSPARI 400MG TAB	$7933.29	Big4	Travere Therapeutics, Inc.	09/14/2026
68974-0400-30FILSPARI 400MG TAB	$10778.91	FSS	Travere Therapeutics, Inc.	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Filspari (2024)

Total Spending

$24.3M

Total Claims

2,074

Beneficiaries

323

Avg Cost/Unit

$372.23

Spending Trend

$4.8M(2023)→$24.3M(2024)

YoY Change:+8.0%

5yr CAGR:+8.0%

Source: CMS Medicare Part D Spending by Drug (2024). 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 patents4 exclusivities▴

TABLET;ORAL | Approved: Feb 17, 2023

Patents (2) · 4 use codes

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

Exclusivities (4)

Code	Date	Status
I-989	Apr 13, 2029	Active
NCE	Feb 17, 2028	Active
ODE-389	Feb 17, 2030	Active
ODE-493	Sep 5, 2031	Active

#002 — 400MG

RLD

2 patents4 exclusivities▾

TABLET;ORAL | Approved: Feb 17, 2023