FDA Orange Book
Generic for Aptiom
Aptiom contains eslicarbazepine acetate. 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 Aptiom is eslicarbazepine acetate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Aptiom products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 400MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 600MG | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | 800MG | Marketed (Rx) | AB | 9 | AB |
NDA 022416, held by SUMITOMO PHARMA AMERICA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eslicarbazepine acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 211238 | AB (A-rated, therapeutically equivalent) | June 29, 2021 | 200MG, 400MG, 600MG, 800MG |
| HETERO LABS LTD UNIT V | 211186 | AB (A-rated, therapeutically equivalent) | August 3, 2023 | 200MG, 400MG, 600MG, 800MG |
| ALKEM LABORATORIES LTD | 211199 | AB (A-rated, therapeutically equivalent) | October 6, 2023 | 200MG, 400MG, 600MG, 800MG |
| APOTEX INC | 211236 | AB (A-rated, therapeutically equivalent) | December 7, 2023 | 200MG, 400MG, 600MG, 800MG |
| TORRENT PHARMACEUTICALS LTD | 211227 | AB (A-rated, therapeutically equivalent) | February 27, 2024 | 200MG, 400MG, 600MG, 800MG |
| LUPIN LTD | 211246 | AB (A-rated, therapeutically equivalent) | March 27, 2024 | 200MG, 400MG, 600MG, 800MG |
| JUBILANT GENERICS LTD | 211219 | AB (A-rated, therapeutically equivalent) | August 4, 2025 | 200MG, 400MG, 600MG, 800MG |
| SPH ZHONGXI PHARMACEUTICAL CO LTD | 211247 | AB (A-rated, therapeutically equivalent) | November 3, 2025 | 200MG, 400MG, 600MG, 800MG |
| AUROBINDO PHARMA LTD | 216481 | AB (A-rated, therapeutically equivalent) | August 5, 2026 | 200MG, 400MG, 600MG, 800MG |
Aptiom patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9206135 | April 21, 2026 | Drug substance | None | 022416 |
| 9643929 | April 21, 2026 | Drug product | None | 022416 |
| 9763954 | September 13, 2028 | Method of use | U-2123 | 022416 |
| 9566244 | October 23, 2028 | Drug product | None | 022416 |
| 10912781 | October 23, 2028 | Drug product | None | 022416 |
| 8372431 | April 17, 2030 | Drug product | None | 022416 |
| 9750747 | August 24, 2032 | Method of use | U-2041 | 022416 |
| 9750747 | August 24, 2032 | Method of use | U-2121 | 022416 |
Aptiom NDC codes
Questions
Is there a generic for Aptiom?
Yes. The generic name for Aptiom is eslicarbazepine acetate. 9 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 Aptiom?
The active ingredient in Aptiom is eslicarbazepine acetate, per the FDA Orange Book.
When does the Aptiom patent expire?
The last patent listed for Aptiom in the Orange Book expires August 24, 2032. 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.