TROKENDI XR — FDA application NDA201635
Listed sponsor: SUPERNUS PHARMS · SUPN company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10314790 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 10314790 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 10314790 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 10314790 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 10314790 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 10314790 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 10314790 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 10314790 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8298580 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8298580 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8298580 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8298580 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8298580 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8298580 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8298580 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8298580 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8663683 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8663683 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8663683 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8663683 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8663683 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8663683 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8663683 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8663683 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8877248 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8877248 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8877248 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8877248 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8877248 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8877248 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8877248 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-106 |
| Patent 8877248 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8889191 | 001 | listed patent expiry date: 2027-11-16 | U-106 |
| Patent 8889191 | 001 | listed patent expiry date: 2027-11-16 | U-1992 |
| Patent 8889191 | 002 | listed patent expiry date: 2027-11-16 | U-106 |
| Patent 8889191 | 002 | listed patent expiry date: 2027-11-16 | U-1992 |
| Patent 8889191 | 003 | listed patent expiry date: 2027-11-16 | U-1992 |
| Patent 8889191 | 003 | listed patent expiry date: 2027-11-16 | U-106 |
| Patent 8889191 | 004 | listed patent expiry date: 2027-11-16 | U-106 |
| Patent 8889191 | 004 | listed patent expiry date: 2027-11-16 | U-1992 |
| Patent 8992989 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8992989 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8992989 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8992989 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8992989 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 8992989 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8992989 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8992989 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9549940 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9549940 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9549940 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9549940 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9549940 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9549940 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9549940 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9549940 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9555004 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9555004 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9555004 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9555004 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9555004 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9555004 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9555004 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9555004 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9622983 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9622983 | 001 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9622983 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9622983 | 002 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9622983 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9622983 | 003 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 9622983 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1992 |
| Patent 9622983 | 004 | listed patent expiry date: 2027-11-16 | drug product, U-1675 |
| Patent 8298576 | 001 | listed patent expiry date: 2028-04-04 | drug product, U-106 |
| Patent 8298576 | 001 | listed patent expiry date: 2028-04-04 | drug product, U-1992 |
| Patent 8298576 | 002 | listed patent expiry date: 2028-04-04 | drug product, U-1992 |
| Patent 8298576 | 002 | listed patent expiry date: 2028-04-04 | drug product, U-106 |
| Patent 8298576 | 003 | listed patent expiry date: 2028-04-04 | drug product, U-106 |
| Patent 8298576 | 003 | listed patent expiry date: 2028-04-04 | drug product, U-1992 |
| Patent 8298576 | 004 | listed patent expiry date: 2028-04-04 | drug product, U-1992 |
| Patent 8298576 | 004 | listed patent expiry date: 2028-04-04 | drug product, U-106 |
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 · CHEMBL220492
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.