Orange Book product · Brand (NDA)

VALCYTE

VALGANCICLOVIR HYDROCHLORIDE

Brand (NDA)NDA 022257TE ABRX CHEPLAPHARM

Aug 28, 2009

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 28, 2009
17 yr 1 mo ago
Today
Patent 8889109 expires
Listed drug product patent expiration.
Dec 11, 2027
in 1 yr 6 mo
Patent 9642911 expires
Listed drug product patent expiration.
Dec 11, 2027
in 1 yr 6 mo

Active ingredient

VALGANCICLOVIR HYDROCHLORIDE

Strength

50MG/ML

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Application

NDA 022257

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
8889109	Dec 11, 2027	in 1 yr 6 mo	Product
9642911	Dec 11, 2027	in 1 yr 6 mo	Product