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DEFINITY

NDA

PERFLUTREN | N021064 | LANTHEUS MEDICAL IMAGING INC

2 strengths11 unique patents0 unique exclusivities

Patent Timeline

11 unique patents by expiration date

Active (11)Today

2026

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Today

Mar. 16, 2037

Dec. 28, 2035

Dec. 28, 2035

Mar. 16, 2037

May. 4, 2037

Mar. 16, 2037

Dec. 28, 2035

Mar. 16, 2037

Mar. 16, 2037

Mar. 16, 2037

Mar. 16, 2037

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

3 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis NCT06057714	—	Recruiting	University of North Carolina, Chapel Hill	30	2021-01-20 → 2026-08
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease NCT06066723	—	Recruiting	University of North Carolina, Chapel Hill	15	2025-06-16 → 2026-08
Contrast Enhanced Ultrasound in Neurosurgery to Improve Glioma Visualization and Border Demarcation NCT07050836	Early Phase 1	Terminated	University of Colorado, Denver	2	2025-12-05 → 2026-01-27

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

Medicare Part B Spending

CMS physician-administered drug spending for Definity (2023)

Total Spending

$3.6M

Total Claims

44,097

Beneficiaries

42,109

ASP Price

—

HCPCS: Q9957 — Injection, perflutren lipid microspheres, per ml

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2024	SUPPL -33	View Letter (PDF)
Jun 6, 2023	SUPPL -32	View Letter (PDF)
Apr 13, 2021	SUPPL -29	View Letter (PDF)
Apr 13, 2021	SUPPL -25	View Letter (PDF)
Nov 18, 2020	SUPPL -24	View Letter (PDF)
Jul 31, 2020	SUPPL -23	View Letter (PDF)
Dec 20, 2018	SUPPL -22	View Letter (PDF)
Jan 24, 2017	SUPPL -20	View Letter (PDF)
Aug 20, 2015	SUPPL -17	View Letter (PDF)
Oct 26, 2011	SUPPL -11	View Letter (PDF)
May 14, 2008	SUPPL -9	View Letter (PDF)
Oct 15, 2007	SUPPL -7	View Letter (PDF)
Jun 2, 2004	SUPPL -4	View Letter (PDF)
Jul 8, 2002	SUPPL -2	View Letter (PDF)
Feb 21, 2002	SUPPL -1	View Letter (PDF)
Jul 31, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 13.04MG/2ML (6.52MG/ML)

RLD

9 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Jul 31, 2001

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9789210	Mar 16, 2037	—	—	—	—
10583207	Dec 28, 2035	—	—	—	—
10583208	Mar 16, 2037	—	—	—	—
10588988	May 4, 2037	—	—	—	—
11266750	Mar 16, 2037	—	—	—	—
11529431	Mar 16, 2037	—	—	—	—
11857646	Mar 16, 2037	—	—	—	—
11925695	Mar 16, 2037	—	—	—	—
12161730	Mar 16, 2037	—	—	—	—

#002 — 13.04MG/2ML (6.52MG/ML)

RLD

11 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Nov 17, 2020