FDA Orange Book

Is there a generic for Subvenite?

Subvenite 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 Subvenite (lamotrigine). The Orange Book shows its last listed patent expires May 29, 2040.

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Subvenite products in the Orange Book

Subvenite products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, oral10MG/MLMarketed (Rx)None0None

NDA 218879, held by OWP PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Subvenite patents

Patents listed for Subvenite
PatentExpiresCoversUse codeNDA
11596634May 29, 2040Method of useU-4271218879
11596634May 29, 2040Method of useU-4272218879
11596634May 29, 2040Method of useU-4273218879
11612566May 29, 2040Method of useU-4271218879
11612566May 29, 2040Method of useU-4272218879
11612566May 29, 2040Method of useU-4273218879
12629377May 29, 2040Drug productU-4539218879
12629377May 29, 2040Drug productU-4540218879
12629377May 29, 2040Drug productU-4541218879
12636289May 29, 2040Drug productNone218879

Subvenite NDC codes

Questions

Is there a generic for Subvenite?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Subvenite (lamotrigine). The Orange Book shows its last listed patent expires May 29, 2040.

What is the generic name for Subvenite?

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

When does the Subvenite patent expire?

The last patent listed for Subvenite in the Orange Book expires May 29, 2040. 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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