Orange Book product · Brand (NDA)

ESKATA

HYDROGEN PEROXIDE

Brand (NDA)NDA 209305DISCN ACLARIS

Dec 14, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 14, 2017
8 yr 8 mo ago
Today
Patent 10098910 expires
Listed drug product patent expiration.
Apr 21, 2035
in 9 yr
Patent 10493103 expires
Listed drug product patent expiration.
Apr 21, 2035
in 9 yr
Patent 10729720 expires
Listed drug product patent expiration.
Apr 21, 2035
in 9 yr
Patent 9980983 expires
Listed method-of-use patent (U-2205) expiration.
Apr 21, 2035
in 9 yr
Patent 9675639 expires
Listed drug product patent expiration.
Jul 04, 2035
in 9 yr 2 mo

Active ingredient

HYDROGEN PEROXIDE

Strength

40%

Dosage form

SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 209305

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
10098910	Apr 21, 2035	in 9 yr	ProductU-2205
10493103	Apr 21, 2035	in 9 yr	Product
10729720	Apr 21, 2035	in 9 yr	Product
9980983	Apr 21, 2035	in 9 yr	U-2205
9675639	Jul 04, 2035	in 9 yr 2 mo	ProductU-2205