Viewing data from:

LUMASON

NDA

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES | N203684 | BRACCO DIAGNOSTICS INC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2026

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Today

10232061

Jul. 6, 2038

10335502

Jul. 6, 2038

11723869

May. 15, 2039

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from International Contrast Ultrasound Society FDA-2018-P-3354 · 14 docket documents The International Contrast Ultrasound Society filed this citizen petition on August 29, 2018, requesting that the FDA remove the boxed warnings from the labels of ultrasound contrast agents (UCAs) Optison, Definity, and Lumason, arguing that peer-reviewed scientific data accumulated since 2007 demon	Other	2018-09-05	Denied	International Contrast Ultrasound Society

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov — 1 recruiting, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
CEUS for Blunt Abdominal Trauma in Children NCT03490929	Phase 4	Recruiting	Children's Hospital of Philadelphia	146	2018-06-01 → 2026-12-31
CEUS Evaluation of Hypoxic Ischemic Injury NCT03549520	Phase 3	Completed	Children's Hospital of Philadelphia	1	2020-12-01 → 2024-05-07
Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis NCT03407001	Early Phase 1	Completed	M.D. Anderson Cancer Center	9	2018-01-12 → 2020-09-15
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy NCT02786810	Phase 2	Completed	University of Tennessee	10	2016-03 → 2016-11
The Role of Contrast Enhanced Ultrasound in Appendicitis NCT03687502	Phase 2	Completed	Children's Mercy Hospital Kansas City	37	2019-01-04 → 2022-07-05
Safety of SonoVue on Pulmonary Hemodynamics NCT01306292	Phase 2	Completed	Bracco Diagnostics, Inc	36	2011-04 → 2011-11
CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis NCT03549507	Phase 3	Terminated	Children's Hospital of Philadelphia	1	2020-11-04 → 2024-05-07
Contrast-Enhanced Ultrasound for Kidney Transplant NCT02911714	Phase 1	Terminated	University of Utah	20	2018-02-21 → 2022-06-30
Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis NCT03295656	Phase 1	Withdrawn	Boston Children's Hospital	—	2020-07-15 → 2020-07-15
Contrast Enhanced Ultrasound Evaluation of Brain Perfusion in Neonatal Post-Hemorrhagic Hydrocephalus NCT03061045	Phase 4	Withdrawn	Johns Hopkins University	—	2017-04-01 → 2018-01-22

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$329.26

Highest Price

$1312.29

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00270-7097-07LUMASON KIT FOR INJECTABLE SUSPENSION	$1312.29	FSS	Bracco Diagnostics, Inc.	04/15/2026
00270-7099-16LUMASON KIT FOR INJECTABLE SUSPENSION	$329.26	FSS	Bracco Diagnostics, Inc.	04/15/2026

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

Medicare Part B Spending

CMS physician-administered drug spending for Lumason (2024)

Total Spending

$314K

Total Claims

4,038

Beneficiaries

3,798

ASP Price

$18.88

Spending Trend

$767K(2019)→$512K(2020)→$243K(2021)→$323K(2022)→$324K(2023)→$314K(2024)

YoY Change:+3.0%

5yr CAGR:+13.4%

HCPCS: Q9950 — Injection, sulfur hexafluoride lipid microspheres, per ml

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 13, 2021	SUPPL -9	View Letter (PDF)
Dec 3, 2020	SUPPL -7	View Letter (PDF)
Nov 15, 2019	SUPPL -5	View Letter (PDF)
Dec 23, 2016	SUPPL -2	View Letter (PDF)
Apr 4, 2016	SUPPL -1	View Letter (PDF)
Oct 15, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60.7MG/25MG

RLD

3 patents0 exclusivities▴

FOR SUSPENSION;INTRAVENOUS | Approved: Oct 15, 2014

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10232061	Jul 6, 2038	—	—	Yes	—	—
10335502	Jul 6, 2038	—	—	Yes	—	—
11723869	May 15, 2039	—	—	Yes		—