# TROKENDI XR — FDA application NDA201635

Informational only - not investment advice.

Application NDA201635 · type NDA · FDA status: approved · original approval 2013-08-16

Listed sponsor: SUPERNUS PHARMS · [SUPN company profile](/company/SUPN/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | Prescription | AB1 | Yes |
| 002 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | Prescription | AB1 | Yes |
| 003 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | Prescription | AB1 | Yes |
| 004 | TROKENDI XR | TOPIRAMATE | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | Prescription | AB1 | Yes |

## Orange Book patent and exclusivity listings

- Patent 10314790, product 001; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 001; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 002; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 002; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 003; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 003; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 004; listed patent expiry date: 2027-11-16.
- Patent 10314790, product 004; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 001; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 001; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 002; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 002; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 003; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 003; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 004; listed patent expiry date: 2027-11-16.
- Patent 8298580, product 004; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 001; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 001; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 002; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 002; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 003; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 003; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 004; listed patent expiry date: 2027-11-16.
- Patent 8663683, product 004; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 001; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 001; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 002; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 002; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 003; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 003; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 004; listed patent expiry date: 2027-11-16.
- Patent 8877248, product 004; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 001; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 001; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 002; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 002; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 003; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 003; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 004; listed patent expiry date: 2027-11-16.
- Patent 8889191, product 004; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 001; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 001; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 002; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 002; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 003; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 003; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 004; listed patent expiry date: 2027-11-16.
- Patent 8992989, product 004; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 001; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 001; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 002; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 002; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 003; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 003; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 004; listed patent expiry date: 2027-11-16.
- Patent 9549940, product 004; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 001; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 001; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 002; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 002; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 003; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 003; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 004; listed patent expiry date: 2027-11-16.
- Patent 9555004, product 004; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 001; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 001; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 002; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 002; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 003; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 003; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 004; listed patent expiry date: 2027-11-16.
- Patent 9622983, product 004; listed patent expiry date: 2027-11-16.
- Patent 8298576, product 001; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 001; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 002; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 002; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 003; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 003; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 004; listed patent expiry date: 2028-04-04.
- Patent 8298576, product 004; listed patent expiry date: 2028-04-04.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- TOPIRAMATE · UNII 0H73WJJ391 · [lmmol compound KJADKKWYZYXHBB-XBWDGYHZSA-N](https://lmmol.com/compound/KJADKKWYZYXHBB-XBWDGYHZSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/SUPN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA201635. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.