FDA Orange Book
Generic for Topamax Sprinkle
Topamax Sprinkle contains topiramate. 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 Topamax Sprinkle is topiramate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Topamax Sprinkle products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 50MG | Discontinued | None | 3 | AB |
NDA 020844, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic topiramate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 078877 | AB (A-rated, therapeutically equivalent) | October 23, 2024 | 50MG |
| RUBICON RESEARCH LTD | 216683 | AB (A-rated, therapeutically equivalent) | May 27, 2025 | 50MG |
| STRIDES PHARMA GLOBAL PTE LTD | 078418 | AB (A-rated, therapeutically equivalent) | February 2, 2026 | 50MG |
Topamax Sprinkle NDC codes
Questions
Is there a generic for Topamax Sprinkle?
Yes. The generic name for Topamax Sprinkle is topiramate. 3 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 Topamax Sprinkle?
The active ingredient in Topamax Sprinkle is topiramate, 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.