FDA Orange Book
Generic for Qudexy XR
Qudexy 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 Qudexy 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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Qudexy 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) | AB2 | 15 | AB1, AB2 |
| capsule, extended release, oral | 150MG | Marketed (Rx) | AB2 | 5 | AB2 |
| capsule, extended release, oral | 200MG | Marketed (Rx) | AB2 | 15 | AB2, AB1 |
| capsule, extended release, oral | 25MG | Marketed (Rx) | AB2 | 15 | AB1, AB2 |
| capsule, extended release, oral | 50MG | Marketed (Rx) | AB2 | 15 | AB1, AB2 |
NDA 205122, held by UPSHER SMITH LABORATORIES LLC. 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, 150MG, 200MG, 25MG, 50MG |
| ZYDUS WORLDWIDE DMCC | 208949 | AB2 (A-rated, therapeutically equivalent) | November 29, 2022 | 100MG, 150MG, 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, 150MG, 200MG, 25MG, 50MG |
| AMTA LABS LTD | 218695 | AB2 (A-rated, therapeutically equivalent) | December 3, 2024 | 100MG, 150MG, 200MG, 25MG, 50MG |
| AJANTA PHARMA LTD | 219564 | AB2 (A-rated, therapeutically equivalent) | September 2, 2025 | 100MG, 150MG, 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 |
Qudexy XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10363224 | March 19, 2033 | Method of use | U-766 | 205122 |
| 9101545 | March 19, 2033 | Drug product | None | 205122 |
| 9555005 | March 19, 2033 | Drug product | None | 205122 |
| 8652527 | March 19, 2033 | Drug product | None | 205122 |
| 8889190 | March 19, 2033 | Drug product | None | 205122 |
Qudexy XR NDC codes
Questions
Is there a generic for Qudexy XR?
Yes. The generic name for Qudexy 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 Qudexy XR?
The active ingredient in Qudexy XR is topiramate, per the FDA Orange Book.
When does the Qudexy XR patent expire?
The last patent listed for Qudexy XR in the Orange Book expires March 19, 2033. 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.