Orange Book product · Brand (NDA)

INLEXZO

GEMCITABINE HYDROCHLORIDE

Brand (NDA)NDA 219683RX JANSSEN BIOTECH

Sep 09, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 09, 2025
9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Sep 09, 2028
in 2 yr 3 mo
Patent 12403086 expires
Listed drug product patent expiration.
Jun 28, 2030
in 4 yr 1 mo
Patent 12576253 expires
Listed drug product patent expiration.
Dec 17, 2030
in 4 yr 7 mo
Patent 8679094 expires
Listed drug product patent expiration.
Apr 15, 2032
in 5 yr 11 mo
Patent 10729823 expires
Listed drug product patent expiration.
Aug 19, 2034
in 8 yr 3 mo
Patent 12447241 expires
Listed drug product patent expiration.
Aug 19, 2034
in 8 yr 3 mo

Active ingredient

GEMCITABINE HYDROCHLORIDE

Strength

EQ 225MG BASE

Dosage form

SYSTEM

Route

INTRAVESICAL

TE code

Not listed

Application

NDA 219683

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
12403086	Jun 28, 2030	in 4 yr 1 mo	Product
12576253	Dec 17, 2030	in 4 yr 7 mo	Product
8679094	Apr 15, 2032	in 5 yr 11 mo	Product
10729823	Aug 19, 2034	in 8 yr 3 mo	Product
12447241	Aug 19, 2034	in 8 yr 3 mo	Product