FDA Orange Book
Generic for Eprontia
Eprontia 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 Eprontia is topiramate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Eprontia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 25MG/ML | Marketed (Rx) | AB | 1 | AB |
NDA 214679, held by AZURITY 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 |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 217795 | AB (A-rated, therapeutically equivalent) | October 31, 2024 | 25MG/ML |
Eprontia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11433046 | August 21, 2040 | Method of use | U-3413 | 214679 |
| 11433046 | August 21, 2040 | Method of use | U-3414 | 214679 |
| 11433046 | August 21, 2040 | Method of use | U-3415 | 214679 |
| 12290503 | August 21, 2040 | Drug product | U-3413 | 214679 |
| 12290503 | August 21, 2040 | Drug product | U-3415 | 214679 |
| 12290503 | August 21, 2040 | Drug product | U-3414 | 214679 |
| 11911362 | August 21, 2040 | Drug product | U-3413 | 214679 |
| 11911362 | August 21, 2040 | Drug product | U-3414 | 214679 |
| 11911362 | August 21, 2040 | Drug product | U-3415 | 214679 |
| 11826343 | August 21, 2040 | Drug product | None | 214679 |
| 11633374 | August 21, 2040 | Drug product | None | 214679 |
Eprontia NDC codes
Questions
Is there a generic for Eprontia?
Yes. The generic name for Eprontia is topiramate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Eprontia?
The active ingredient in Eprontia is topiramate, per the FDA Orange Book.
When does the Eprontia patent expire?
The last patent listed for Eprontia in the Orange Book expires August 21, 2040. 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.