FDA Orange Book

Is there a generic for Likmez?

Likmez contains metronidazole. 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 Likmez (metronidazole). The Orange Book shows its last listed patent expires October 4, 2039.

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Likmez products in the Orange Book

Likmez products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, oral500MG/5MLMarketed (Rx)None0None

NDA 216755, held by SAPTALIS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Likmez patents

Patents listed for Likmez
PatentExpiresCoversUse codeNDA
12257236January 16, 2039Drug productU-3169216755
12257236January 16, 2039Drug productU-4163216755
12257236January 16, 2039Drug productU-4164216755
11541035October 4, 2039Drug productNone216755

Likmez NDC codes

Questions

Is there a generic for Likmez?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Likmez (metronidazole). The Orange Book shows its last listed patent expires October 4, 2039.

What is the generic name for Likmez?

The active ingredient in Likmez is metronidazole, per the FDA Orange Book.

When does the Likmez patent expire?

The last patent listed for Likmez in the Orange Book expires October 4, 2039. 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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