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ELUCIREM

NDA

GADOPICLENOL | N216986 | GUERBET

7 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

2036

2037

2038

2039

2040

Today

Sep. 19, 2028

Aug. 6, 2039

Jan. 17, 2040

Jan. 17, 2040

NCE

Sep. 21, 2027

NPP

Feb. 20, 2029

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 B Spending

CMS physician-administered drug spending for Elucirem (2023)

Total Spending

$124K

Total Claims

2,028

Beneficiaries

1,981

ASP Price

—

HCPCS: A9573 — Injection, gadopiclenol, 1 ml

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2026	SUPPL -9	View Letter (PDF)
Mar 6, 2025	SUPPL -6	View Letter (PDF)
Aug 16, 2024	SUPPL -3	View Letter (PDF)
Jul 24, 2024	SUPPL -5	View Letter (PDF)
Jan 29, 2024	SUPPL -2	View Letter (PDF)
Sep 22, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — 1.4553GM/3ML (485.1MG/ML)

RLD

4 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8114863	Sep 19, 2028	—	Yes	—	—	—
10973934	Aug 6, 2039	—	Yes	—	—	—
11590246	Jan 17, 2040	—	—	Yes	—	—
12064487	Jan 17, 2040	—	—	—	U-4424	—

Exclusivities (2)

Code	Date	Status
NCE	Sep 21, 2027	Active
NPP	Feb 20, 2029	Active

#002 — 3.63825GM/7.5ML (485.1MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

#003 — 4.851GM/10ML (485.1MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

#004 — 7.2765GM/15ML (485.1MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

#005 — 14.553GM/30ML (485.1MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

#006 — 24.255GM/50ML (485.1MG/ML)

RLD

4 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022

#007 — 48.51GM/100ML (485.1MG/ML)

RLD

3 patents2 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 21, 2022