Orange Book product · Brand (NDA)

MOTPOLY XR

LACOSAMIDE

Brand (NDA)NDA 216185RX AUCTA

May 04, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 04, 2023
3 yr 2 mo ago
Today
Patent 11337943 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo
Patent 11337943 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo
Patent 11883374 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo
Patent 11883374 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo
Patent 12042474 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo
Patent 12042474 expires
Listed drug product patent expiration.
Jun 05, 2040
in 14 yr 2 mo

Active ingredient

LACOSAMIDE

Strength

100MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 216185

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
11337943	Jun 05, 2040	in 14 yr 2 mo	ProductU-3660
11337943	Jun 05, 2040	in 14 yr 2 mo	ProductU-3954
11883374	Jun 05, 2040	in 14 yr 2 mo	ProductU-3660
11883374	Jun 05, 2040	in 14 yr 2 mo	ProductU-3954
12042474	Jun 05, 2040	in 14 yr 2 mo	ProductU-3660
12042474	Jun 05, 2040	in 14 yr 2 mo	ProductU-3954