Orange Book product · Brand (NDA)

VIVIMUSTA

BENDAMUSTINE HYDROCHLORIDE

Brand (NDA)NDA 212209RX AZURITY

Dec 07, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 07, 2022
3 yr 7 mo ago
Today
Patent 11707450 expires
Listed drug product patent expiration.
Jul 29, 2042
in 16 yr 4 mo
Patent 11844784 expires
Listed drug product patent expiration.
Jul 29, 2042
in 16 yr 4 mo
Patent 12208086 expires
Listed drug product patent expiration.
Jul 29, 2042
in 16 yr 4 mo
Patent 12419867 expires
Listed drug product patent expiration.
Jul 29, 2042
in 16 yr 4 mo

Active ingredient

BENDAMUSTINE HYDROCHLORIDE

Strength

100MG/4ML (25MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212209

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
11707450	Jul 29, 2042	in 16 yr 4 mo	Product
11844784	Jul 29, 2042	in 16 yr 4 mo	Product
12208086	Jul 29, 2042	in 16 yr 4 mo	Product
12419867	Jul 29, 2042	in 16 yr 4 mo	Product