Viewing data from:

TRUSELTIQ

NDA

INFIGRATINIB PHOSPHATE | N214622 | HELSINN HEALTHCARE SA

2 strengths4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Aug. 25, 2029

Aug. 6, 2028

Dec. 11, 2034

Dec. 11, 2034

NCE

May. 28, 2026

ODE-353

May. 28, 2028

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 Truseltiq (2023)

Total Spending

$351K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$823.32

Spending Trend

$771K(2021)→$2.7M(2022)→$351K(2023)

YoY Change:+22.8%

5yr CAGR:+5.8%

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 1, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

RLD

4 patents2 exclusivities▴

CAPSULE;ORAL | Approved: May 28, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8552002	Aug 25, 2029	—	Yes	Yes	—	—
9067896	Aug 6, 2028	—	Yes	—	—	—
10278969	Dec 11, 2034	—	—	Yes	—	—
11160804	Dec 11, 2034	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	May 28, 2026	Expired
ODE-353	May 28, 2028	Active

#002 — 100MG

RLD

4 patents2 exclusivities▾

CAPSULE;ORAL | Approved: May 28, 2021