# OXTELLAR XR — FDA application NDA202810

Informational only - not investment advice.

Application NDA202810 · type NDA · FDA status: approved · original approval 2012-10-19

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 | 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 |

## Orange Book patent and exclusivity listings

- Patent 10220042, product 001; listed patent expiry date: 2027-04-13.
- Patent 10220042, product 002; listed patent expiry date: 2027-04-13.
- Patent 10220042, product 003; listed patent expiry date: 2027-04-13.
- Patent 11166960, product 001; listed patent expiry date: 2027-04-13.
- Patent 11166960, product 002; listed patent expiry date: 2027-04-13.
- Patent 11166960, product 003; listed patent expiry date: 2027-04-13.
- Patent 11896599, product 001; listed patent expiry date: 2027-04-13.
- Patent 11896599, product 002; listed patent expiry date: 2027-04-13.
- Patent 11896599, product 003; listed patent expiry date: 2027-04-13.
- Patent 7722898, product 001; listed patent expiry date: 2027-04-13.
- Patent 7722898, product 002; listed patent expiry date: 2027-04-13.
- Patent 7722898, product 003; listed patent expiry date: 2027-04-13.
- Patent 7910131, product 001; listed patent expiry date: 2027-04-13.
- Patent 7910131, product 002; listed patent expiry date: 2027-04-13.
- Patent 7910131, product 003; listed patent expiry date: 2027-04-13.
- Patent 8617600, product 001; listed patent expiry date: 2027-04-13.
- Patent 8617600, product 002; listed patent expiry date: 2027-04-13.
- Patent 8617600, product 003; listed patent expiry date: 2027-04-13.
- Patent 8821930, product 001; listed patent expiry date: 2027-04-13.
- Patent 8821930, product 002; listed patent expiry date: 2027-04-13.
- Patent 8821930, product 003; listed patent expiry date: 2027-04-13.
- Patent 9119791, product 001; listed patent expiry date: 2027-04-13.
- Patent 9119791, product 002; listed patent expiry date: 2027-04-13.
- Patent 9119791, product 003; listed patent expiry date: 2027-04-13.
- Patent 9351975, product 001; listed patent expiry date: 2027-04-13.
- Patent 9351975, product 002; listed patent expiry date: 2027-04-13.
- Patent 9351975, product 003; listed patent expiry date: 2027-04-13.
- Patent 9370525, product 001; listed patent expiry date: 2027-04-13.
- Patent 9370525, product 002; listed patent expiry date: 2027-04-13.
- Patent 9370525, product 003; listed patent expiry date: 2027-04-13.
- Patent 9855278, product 001; listed patent expiry date: 2027-04-13.
- Patent 9855278, product 002; listed patent expiry date: 2027-04-13.
- Patent 9855278, product 003; listed patent expiry date: 2027-04-13.

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](https://lmmol.com/compound/CTRLABGOLIVAIY-UHFFFAOYSA-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:NDA202810. FDA data retrieved 2026-08-07.

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