FDA Orange Book
Generic for Trokendi XR
Trokendi XR 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 Trokendi XR is topiramate. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Trokendi XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 100MG | Marketed (Rx) | AB1 | 15 | AB1, AB2 |
| capsule, extended release, oral | 200MG | Marketed (Rx) | AB1 | 15 | AB2, AB1 |
| capsule, extended release, oral | 25MG | Marketed (Rx) | AB1 | 15 | AB1, AB2 |
| capsule, extended release, oral | 50MG | Marketed (Rx) | AB1 | 15 | AB1, AB2 |
NDA 201635, held by SUPERNUS 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 WORLDWIDE DMCC | 207382 | AB1 (A-rated, therapeutically equivalent) | November 24, 2017 | 100MG, 200MG, 25MG, 50MG |
| GLENMARK PHARMACEUTICALS LTD | 210278 | AB2 (A-rated, therapeutically equivalent) | February 1, 2021 | 100MG, 200MG, 25MG, 50MG |
| ZYDUS WORLDWIDE DMCC | 208949 | AB2 (A-rated, therapeutically equivalent) | November 29, 2022 | 100MG, 200MG, 25MG, 50MG |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 206210 | AB1 (A-rated, therapeutically equivalent) | March 10, 2023 | 100MG, 200MG, 25MG, 50MG |
| PH HEALTH LTD | 205976 | AB1 (A-rated, therapeutically equivalent) | May 4, 2023 | 100MG, 200MG, 25MG, 50MG |
| ALKEM LABORATORIES LTD | 217248 | AB1 (A-rated, therapeutically equivalent) | June 20, 2023 | 100MG, 200MG, 25MG, 50MG |
| AJANTA PHARMA LTD | 215663 | AB1 (A-rated, therapeutically equivalent) | August 15, 2023 | 100MG, 200MG, 25MG, 50MG |
| DR REDDYS LABORATORIES LTD | 217231 | AB1 (A-rated, therapeutically equivalent) | November 17, 2023 | 100MG, 200MG, 25MG, 50MG |
| LUPIN LTD | 215561 | AB1 (A-rated, therapeutically equivalent) | July 11, 2024 | 100MG, 200MG, 25MG, 50MG |
| XIAMEN LP PHARMACUETICAL CO LTD | 215638 | AB2 (A-rated, therapeutically equivalent) | November 5, 2024 | 100MG, 200MG, 25MG, 50MG |
| AMTA LABS LTD | 218695 | AB2 (A-rated, therapeutically equivalent) | December 3, 2024 | 100MG, 200MG, 25MG, 50MG |
| AJANTA PHARMA LTD | 219564 | AB2 (A-rated, therapeutically equivalent) | September 2, 2025 | 100MG, 200MG, 25MG, 50MG |
| ASCENT PHARMACEUTICALS INC | 217443 | AB1 (A-rated, therapeutically equivalent) | January 12, 2026 | 100MG, 200MG, 25MG, 50MG |
| BIOCON PHARMA LTD | 220943 | AB1 (A-rated, therapeutically equivalent) | July 22, 2026 | 100MG, 200MG, 25MG, 50MG |
| MICRO LABS LTD | 219183 | AB1 (A-rated, therapeutically equivalent) | September 4, 2026 | 100MG, 200MG, 25MG, 50MG |
Trokendi XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8663683 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8663683 | November 16, 2027 | Drug product | U-106 | 201635 |
| 8992989 | November 16, 2027 | Drug product | U-1675 | 201635 |
| 8889191 | November 16, 2027 | Method of use | U-106 | 201635 |
| 9549940 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8298580 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8877248 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8877248 | November 16, 2027 | Drug product | U-106 | 201635 |
| 9555004 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 10314790 | November 16, 2027 | Drug product | U-1675 | 201635 |
| 9622983 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8992989 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8889191 | November 16, 2027 | Method of use | U-1992 | 201635 |
| 9549940 | November 16, 2027 | Drug product | U-1675 | 201635 |
| 9622983 | November 16, 2027 | Drug product | U-1675 | 201635 |
| 9555004 | November 16, 2027 | Drug product | U-1675 | 201635 |
| 10314790 | November 16, 2027 | Drug product | U-1992 | 201635 |
| 8298580 | November 16, 2027 | Drug product | U-106 | 201635 |
| 8298576 | April 4, 2028 | Drug product | U-106 | 201635 |
| 8298576 | April 4, 2028 | Drug product | U-1992 | 201635 |
Trokendi XR NDC codes
Questions
Is there a generic for Trokendi XR?
Yes. The generic name for Trokendi XR is topiramate. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Trokendi XR?
The active ingredient in Trokendi XR is topiramate, per the FDA Orange Book.
When does the Trokendi XR patent expire?
The last patent listed for Trokendi XR in the Orange Book expires April 4, 2028. 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.
More on Trokendi XR and Topiramate
- What is Trokendi XR used for?FDA label uses
- Is Trokendi XR a controlled substance?Federal schedule
- What is Topiramate used for?FDA label uses
- Is Topiramate a controlled substance?Federal schedule
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- NDC 17772-101Trokendi XR NDC record
- NDC 17772-102Trokendi XR NDC record
- NDC 17772-103Trokendi XR NDC record