Orange Book product · Brand (NDA)

ZERVIATE

CETIRIZINE HYDROCHLORIDE

Brand (NDA)NDA 208694RX HARROW EYE

May 30, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 30, 2017
9 yr 2 mo ago
Today
Patent 8829005 expires
Listed method-of-use patent (U-1680) expiration.
Mar 15, 2030
in 3 yr 10 mo
Patent 9750684 expires
Listed drug product patent expiration.
Mar 15, 2030
in 3 yr 10 mo
Patent 9993471 expires
Listed method-of-use patent (U-1680) expiration.
Mar 15, 2030
in 3 yr 10 mo
Patent 8829005*PED expires
Listed listed patent expiration.
Sep 15, 2030
in 4 yr 4 mo
Patent 9254286 expires
Listed drug product patent expiration.
Jul 09, 2032
in 6 yr 2 mo
Patent 9254286*PED expires
Listed listed patent expiration.
Jan 09, 2033
in 6 yr 8 mo

Active ingredient

CETIRIZINE HYDROCHLORIDE

Strength

EQ 0.24% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 208694

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
8829005	Mar 15, 2030	in 3 yr 10 mo	U-1680
9750684	Mar 15, 2030	in 3 yr 10 mo	Product
9993471	Mar 15, 2030	in 3 yr 10 mo	U-1680
8829005*PED	Sep 15, 2030	in 4 yr 4 mo
9254286	Jul 09, 2032	in 6 yr 2 mo	Product
9254286*PED	Jan 09, 2033	in 6 yr 8 mo