FDA Orange Book

Is there a generic for Motpoly XR?

Motpoly XR contains lacosamide. 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 Motpoly XR (lacosamide). The Orange Book shows its last listed patent expires June 5, 2040.

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Motpoly XR products in the Orange Book

Motpoly XR products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral100MGMarketed (Rx)None0None
capsule, extended release, oral150MGMarketed (Rx)None0None
capsule, extended release, oral200MGMarketed (Rx)None0None

NDA 216185, held by AUCTA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Motpoly XR patents

Patents listed for Motpoly XR
PatentExpiresCoversUse codeNDA
11337943June 5, 2040Drug productU-3660216185
12042474June 5, 2040Drug productU-3660216185
12042474June 5, 2040Drug productU-3954216185
11883374June 5, 2040Drug productU-3660216185
11883374June 5, 2040Drug productU-3954216185
11337943June 5, 2040Drug productU-3954216185

Motpoly XR NDC codes

Questions

Is there a generic for Motpoly XR?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Motpoly XR (lacosamide). The Orange Book shows its last listed patent expires June 5, 2040.

What is the generic name for Motpoly XR?

The active ingredient in Motpoly XR is lacosamide, per the FDA Orange Book.

When does the Motpoly XR patent expire?

The last patent listed for Motpoly XR in the Orange Book expires June 5, 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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