Orange Book product · Brand (NDA)

ZYCLARA

IMIQUIMOD

Brand (NDA)NDA 022483RX BAUSCH

Jul 15, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 15, 2011
15 yr 2 mo ago
Today
Patent 11318130 expires
Listed method-of-use patent (U-68) expiration.
Dec 11, 2029
in 3 yr 6 mo
Patent 8222270 expires
Listed method-of-use patent (U-68) expiration.
Dec 11, 2029
in 3 yr 6 mo

Active ingredient

IMIQUIMOD

Strength

2.5%

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 022483

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
11318130	Dec 11, 2029	in 3 yr 6 mo	U-68
8222270	Dec 11, 2029	in 3 yr 6 mo	U-68