FDA Orange Book

Is there a generic for Oseni?

Oseni contains alogliptin benzoate and pioglitazone. 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 Oseni (alogliptin benzoate and pioglitazone). The Orange Book shows its last listed patent expires June 4, 2029.

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Oseni products in the Orange Book

Oseni products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 12.5MG BASE;EQ 15MG BASEDiscontinuedNone0None
tablet, oralEQ 12.5MG BASE;EQ 30MG BASEMarketed (Rx)None0None
tablet, oralEQ 12.5MG BASE;EQ 45MG BASEDiscontinuedNone0None
tablet, oralEQ 25MG BASE;EQ 15MG BASEMarketed (Rx)None0None
tablet, oralEQ 25MG BASE;EQ 30MG BASEMarketed (Rx)None0None
tablet, oralEQ 25MG BASE;EQ 45MG BASEMarketed (Rx)None0None

NDA 022426, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Oseni patents

Patents listed for Oseni
PatentExpiresCoversUse codeNDA
7807689June 27, 2028Drug substance, Drug productU-1337022426
8637079June 4, 2029Drug productNone022426

Oseni NDC codes

Questions

Is there a generic for Oseni?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Oseni (alogliptin benzoate and pioglitazone). The Orange Book shows its last listed patent expires June 4, 2029.

What is the generic name for Oseni?

The active ingredient in Oseni is alogliptin benzoate and pioglitazone, per the FDA Orange Book.

When does the Oseni patent expire?

The last patent listed for Oseni in the Orange Book expires June 4, 2029. 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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