Orange Book product · Brand (NDA)

ELUCIREM

GADOPICLENOL

Brand (NDA)NDA 216986RX GUERBET

Sep 21, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 21, 2022
3 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
Patent 8114863 expires
Listed drug substance patent expiration.
Sep 19, 2028
in 2 yr 3 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
Patent 10973934 expires
Listed drug substance patent expiration.
Aug 06, 2039
in 13 yr 4 mo
Patent 11590246 expires
Listed drug product patent expiration.
Jan 17, 2040
in 13 yr 9 mo
Patent 12064487 expires
Listed method-of-use patent (U-4424) expiration.
Jan 17, 2040
in 13 yr 9 mo

Active ingredient

GADOPICLENOL

Strength

1.4553GM/3ML (485.1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216986

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8114863	Sep 19, 2028	in 2 yr 3 mo	Substance
10973934	Aug 06, 2039	in 13 yr 4 mo	Substance
11590246	Jan 17, 2040	in 13 yr 9 mo	Product
12064487	Jan 17, 2040	in 13 yr 9 mo	U-4424