Orange Book product · Brand (NDA)

ELEPSIA XR

LEVETIRACETAM

Brand (NDA)NDA 204417DISCN TRIPOINT

Dec 20, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2018
7 yr 7 mo ago
Patent 8425938 expires
Listed drug product patent expiration.
Feb 22, 2026
4 mo ago
Patent 8535717 expires
Listed drug product patent expiration.
Feb 22, 2026
4 mo ago
Today
Patent 8163306 expires
Listed drug product patent expiration.
Sep 03, 2027
in 1 yr 3 mo
Patent 8431156 expires
Listed drug product patent expiration.
Oct 31, 2027
in 1 yr 5 mo
Patent 8470367 expires
Listed drug product patent expiration.
Oct 31, 2027
in 1 yr 5 mo

Active ingredient

LEVETIRACETAM

Strength

1GM

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 204417

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
8425938	Feb 22, 2026	4 mo ago	Product
8535717	Feb 22, 2026	4 mo ago	Product
8163306	Sep 03, 2027	in 1 yr 3 mo	Product
8431156	Oct 31, 2027	in 1 yr 5 mo	Product
8470367	Oct 31, 2027	in 1 yr 5 mo	Product