Orange Book product · Brand (NDA)

QUDEXY XR

TOPIRAMATE

Brand (NDA)NDA 205122TE AB2RX UPSHER SMITH LABS

Mar 11, 2014

Approved

Brand (NDA)

Application

AB2

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 11, 2014
12 yr 5 mo ago
Today
Patent 10363224 expires
Listed method-of-use patent (U-766) expiration.
Mar 19, 2033
in 6 yr 10 mo
Patent 8652527 expires
Listed drug product patent expiration.
Mar 19, 2033
in 6 yr 10 mo
Patent 8889190 expires
Listed drug product patent expiration.
Mar 19, 2033
in 6 yr 10 mo
Patent 9101545 expires
Listed drug product patent expiration.
Mar 19, 2033
in 6 yr 10 mo
Patent 9555005 expires
Listed drug product patent expiration.
Mar 19, 2033
in 6 yr 10 mo

Active ingredient

TOPIRAMATE

Strength

25MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB2

Application

NDA 205122

Product number

001

Marketing status

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
10363224	Mar 19, 2033	in 6 yr 10 mo	U-766
8652527	Mar 19, 2033	in 6 yr 10 mo	Product
8889190	Mar 19, 2033	in 6 yr 10 mo	Product
9101545	Mar 19, 2033	in 6 yr 10 mo	Product
9555005	Mar 19, 2033	in 6 yr 10 mo	Product