Orange Book product · Brand (NDA)

SUBVENITE

LAMOTRIGINE

Brand (NDA)NDA 218879RX OWP PHARMS

Sep 16, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 16, 2025
9 mo ago
Today
Patent 11596634 expires
Listed method-of-use patent (U-4271) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 11596634 expires
Listed method-of-use patent (U-4272) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 11596634 expires
Listed method-of-use patent (U-4273) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 11612566 expires
Listed method-of-use patent (U-4271) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 11612566 expires
Listed method-of-use patent (U-4272) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 11612566 expires
Listed method-of-use patent (U-4273) expiration.
May 29, 2040
in 14 yr 2 mo

Active ingredient

LAMOTRIGINE

Strength

10MG/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 218879

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
11596634	May 29, 2040	in 14 yr 2 mo	U-4271
11596634	May 29, 2040	in 14 yr 2 mo	U-4272
11596634	May 29, 2040	in 14 yr 2 mo	U-4273
11612566	May 29, 2040	in 14 yr 2 mo	U-4271
11612566	May 29, 2040	in 14 yr 2 mo	U-4272
11612566	May 29, 2040	in 14 yr 2 mo	U-4273