FDA Orange Book

Is there a generic for Lamlique?

Lamlique contains lamotrigine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lamlique (lamotrigine). The Orange Book shows its last listed patent expires February 14, 2045.

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Lamlique products in the Orange Book

Lamlique products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, oralEQ 25MG BASE/MLMarketed (Rx)None0None
suspension, oralEQ 5MG BASE/MLMarketed (Rx)None0None

NDA 221109, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Lamlique patents

Patents listed for Lamlique
PatentExpiresCoversUse codeNDA
12605388February 14, 2045Drug productNone221109

Questions

Is there a generic for Lamlique?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Lamlique (lamotrigine). The Orange Book shows its last listed patent expires February 14, 2045.

What is the generic name for Lamlique?

The active ingredient in Lamlique is lamotrigine, per the FDA Orange Book.

When does the Lamlique patent expire?

The last patent listed for Lamlique in the Orange Book expires February 14, 2045. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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