FDA Orange Book
Generic for Sonata
Sonata contains zaleplon. 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
Yes. The generic name for Sonata is zaleplon. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sonata products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 5 | AB |
| capsule, oral | 5MG | Discontinued | None | 5 | AB |
NDA 020859, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zaleplon
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 078829 | AB (A-rated, therapeutically equivalent) | June 6, 2008 | 10MG, 5MG |
| HIKMA PHARMACEUTICALS USA INC | 077237 | AB (A-rated, therapeutically equivalent) | June 6, 2008 | 10MG, 5MG |
| UNICHEM LABORATORIES LTD | 078989 | AB (A-rated, therapeutically equivalent) | June 6, 2008 | 10MG, 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 077505 | AB (A-rated, therapeutically equivalent) | June 20, 2008 | 10MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 090374 | AB (A-rated, therapeutically equivalent) | September 17, 2009 | 10MG, 5MG |
Questions
Is there a generic for Sonata?
Yes. The generic name for Sonata is zaleplon. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sonata?
The active ingredient in Sonata is zaleplon, per the FDA Orange Book.
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.