FDA Orange Book
Generic for Topamax
Topamax 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 is topiramate. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 8 Topamax products the Orange Book lists.
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Topamax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 15MG | Marketed (Rx) | AB | 8 | AB |
| capsule, oral | 25MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 100MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 200MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 300MG | Discontinued | None | 0 | None |
| tablet, oral | 400MG | Discontinued | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | AB | 9 | AB |
NDA 020844, 020505, 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 |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 076311 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| AUROBINDO PHARMA LTD | 078462 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| CIPLA LTD | 076343 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 077627 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| INVAGEN PHARMACEUTICALS INC | 079162 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| UNICHEM LABORATORIES LTD | 090162 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 078235 | AB (A-rated, therapeutically equivalent) | March 27, 2009 | 100MG, 200MG, 25MG, 50MG |
| STRIDES PHARMA GLOBAL PTE LTD | 078418 | AB (A-rated, therapeutically equivalent) | October 14, 2009 | 15MG, 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 078877 | AB (A-rated, therapeutically equivalent) | October 14, 2009 | 15MG, 25MG |
| AIPING PHARMACEUTICAL INC | 078499 | AB (A-rated, therapeutically equivalent) | January 7, 2010 | 100MG, 200MG, 25MG, 50MG |
| ASCENT PHARMACEUTICALS INC | 215414 | AB (A-rated, therapeutically equivalent) | August 26, 2021 | 100MG, 200MG, 25MG, 50MG |
| AUROBINDO PHARMA LTD | 215449 | AB (A-rated, therapeutically equivalent) | September 27, 2023 | 15MG, 25MG |
| TWI PHARMACEUTICALS INC | 217694 | AB (A-rated, therapeutically equivalent) | December 5, 2023 | 15MG, 25MG |
| ALKEM LABORATORIES LTD | 218482 | AB (A-rated, therapeutically equivalent) | June 13, 2024 | 15MG, 25MG |
| GLENMARK PHARMACEUTICALS LTD | 217869 | AB (A-rated, therapeutically equivalent) | July 16, 2024 | 15MG, 25MG |
| PHARMAZONE | 218642 | AB (A-rated, therapeutically equivalent) | October 10, 2024 | 15MG, 25MG |
| RUBICON RESEARCH LTD | 216683 | AB (A-rated, therapeutically equivalent) | May 27, 2025 | 15MG, 25MG |
Topamax NDC codes
Questions
Is there a generic for Topamax?
Yes. The generic name for Topamax is topiramate. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 8 Topamax products the Orange Book lists.
What is the generic name for Topamax?
The active ingredient in Topamax 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.
More on Topamax and Topiramate
- What is Topamax used for?FDA label uses
- Is Topamax a controlled substance?Federal schedule
- What is Topiramate used for?FDA label uses
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