Orange Book product · Brand (NDA)

TYZAVAN

VANCOMYCIN HYDROCHLORIDE

Brand (NDA)NDA 211962RX HIKMA

Feb 15, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 15, 2019
7 yr 5 mo ago
Today
Patent 10039804 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 10188697 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 10849956 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 11517609 expires
Listed method-of-use patent (U-282) expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 11628200 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo
Patent 12161690 expires
Listed drug product patent expiration.
Nov 06, 2035
in 9 yr 6 mo

Active ingredient

VANCOMYCIN HYDROCHLORIDE

Strength

EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 211962

Product number

002

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
10039804	Nov 06, 2035	in 9 yr 6 mo	ProductU-282
10188697	Nov 06, 2035	in 9 yr 6 mo	ProductU-282
10849956	Nov 06, 2035	in 9 yr 6 mo	Product
11517609	Nov 06, 2035	in 9 yr 6 mo	U-282
11628200	Nov 06, 2035	in 9 yr 6 mo	Product
12161690	Nov 06, 2035	in 9 yr 6 mo	Product