OXTELLAR XR — FDA application NDA202810
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 | OXTELLAR XR | OXCARBAZEPINE | TABLET, EXTENDED RELEASE | ORAL | 150MG | Prescription | AB | Yes |
| 002 | OXTELLAR XR | OXCARBAZEPINE | TABLET, EXTENDED RELEASE | ORAL | 300MG | Prescription | AB | Yes |
| 003 | OXTELLAR XR | OXCARBAZEPINE | TABLET, EXTENDED RELEASE | ORAL | 600MG | Prescription | AB | 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 10220042 | 001 | listed patent expiry date: 2027-04-13 | U-2501 |
| Patent 10220042 | 002 | listed patent expiry date: 2027-04-13 | U-2501 |
| Patent 10220042 | 003 | listed patent expiry date: 2027-04-13 | U-2501 |
| Patent 11166960 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 11166960 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 11166960 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 11896599 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 11896599 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 11896599 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 7722898 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 7722898 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 7722898 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 7910131 | 001 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 7910131 | 002 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 7910131 | 003 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 8617600 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 8617600 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 8617600 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 8821930 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 8821930 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 8821930 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9119791 | 001 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 9119791 | 002 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 9119791 | 003 | listed patent expiry date: 2027-04-13 | U-2041 |
| Patent 9351975 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9351975 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9351975 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9370525 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9370525 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9370525 | 003 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9855278 | 001 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9855278 | 002 | listed patent expiry date: 2027-04-13 | drug product |
| Patent 9855278 | 003 | listed patent expiry date: 2027-04-13 | drug product |
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
- OXCARBAZEPINE · UNII VZI5B1W380 · lmmol compound CTRLABGOLIVAIY-UHFFFAOYSA-N · CHEMBL1068
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.