Orange Book product · Brand (NDA)

SITAVIG

ACYCLOVIR

Brand (NDA)NDA 203791DISCN LIGAND PHARMS

Apr 12, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 12, 2013
13 yr 5 mo ago
Today
Patent 8791127 expires
Listed drug product patent expiration.
Mar 23, 2027
in 9 mo
Patent 8747896 expires
Listed drug product patent expiration.
Jun 03, 2027
in 1 yr
Patent 8592434 expires
Listed drug product patent expiration.
Jun 16, 2030
in 4 yr 1 mo

Active ingredient

ACYCLOVIR

Strength

50MG

Dosage form

TABLET

Route

BUCCAL

TE code

Not listed

Application

NDA 203791

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8791127	Mar 23, 2027	in 9 mo	ProductU-1460
8747896	Jun 03, 2027	in 1 yr	ProductU-1460
8592434	Jun 16, 2030	in 4 yr 1 mo	ProductU-1460