FDA Orange Book

Is there a generic for Uzedy?

Uzedy contains risperidone. 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 Uzedy (risperidone). The Orange Book shows its last listed patent expires March 17, 2042 and its last listed exclusivity ends April 28, 2026.

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Uzedy products in the Orange Book

Uzedy products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
suspension, extended release, subcutaneous100MG/0.28ML (100MG/0.28ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous125MG/0.35ML (125MG/0.35ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous150MG/0.42ML (150MG/0.42ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous200MG/0.56ML (200MG/0.56ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous250MG/0.7ML (250MG/0.7ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous50MG/0.14ML (50MG/0.14ML)Marketed (Rx)None0None
suspension, extended release, subcutaneous75MG/0.21ML (75MG/0.21ML)Marketed (Rx)None0None

NDA 213586, held by TEVA NEUROSCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Uzedy patents

Patents listed for Uzedy
PatentExpiresCoversUse codeNDA
8221778November 12, 2027Drug productU-601213586
8221778November 12, 2027Drug productU-543213586
8741327November 12, 2027Drug productU-543213586
9023897April 5, 2033Drug productNone213586
12128132September 11, 2040Drug productU-601213586
12383493September 11, 2040Drug productU-601213586
12383493September 11, 2040Drug productU-543213586
12128132September 11, 2040Drug productU-543213586
12329851March 17, 2042Method of useU-4214213586

Uzedy exclusivity

Exclusivity listed for Uzedy
CodeMeaningExpiresNDA
NPNew productApril 28, 2026213586

Uzedy NDC codes

Questions

Is there a generic for Uzedy?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Uzedy (risperidone). The Orange Book shows its last listed patent expires March 17, 2042 and its last listed exclusivity ends April 28, 2026.

What is the generic name for Uzedy?

The active ingredient in Uzedy is risperidone, per the FDA Orange Book.

When does the Uzedy patent expire?

The last patent listed for Uzedy in the Orange Book expires March 17, 2042. 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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