Orange Book product · Brand (NDA)

IMKELDI

IMATINIB MESYLATE

Brand (NDA)NDA 219097RX SHORLA ONCOLOGY

Nov 22, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 22, 2024
1 yr 7 mo ago
Today
Patent 11957681 expires
Listed drug product patent expiration.
Apr 27, 2040
in 14 yr 1 mo

Active ingredient

IMATINIB MESYLATE

Strength

EQ 80MG BASE/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 219097

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
11957681	Apr 27, 2040	in 14 yr 1 mo	Product