# XYREM — FDA application NDA021196

Informational only - not investment advice.

Application NDA021196 · type NDA · FDA status: approved · original approval 2002-07-17

Listed sponsor: JAZZ PHARMS · [JAZZ company profile](/company/JAZZ/) · 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 | XYREM | SODIUM OXYBATE | SOLUTION | ORAL | 0.5GM/ML | Prescription | AA | Yes |

## Orange Book patent and exclusivity listings

- Patent 10213400, product 001; listed patent expiry date: 2033-03-15.
- Patent 10864181, product 001; listed patent expiry date: 2033-03-15.
- Patent 11253494, product 001; listed patent expiry date: 2033-03-15.
- Patent 11253494, product 001; listed patent expiry date: 2033-03-15.
- Patent 11986446, product 001; listed patent expiry date: 2033-03-15.
- Patent 8772306, product 001; listed patent expiry date: 2033-03-15.
- Patent 9050302, product 001; listed patent expiry date: 2033-03-15.
- Patent 9486426, product 001; listed patent expiry date: 2033-03-15.
- Patent 10213400, product 001; listed patent expiry date: 2033-09-15.
- Patent 10864181, product 001; listed patent expiry date: 2033-09-15.
- Patent 11253494, product 001; listed patent expiry date: 2033-09-15.
- Patent 8772306, product 001; listed patent expiry date: 2033-09-15.
- Patent 9050302, product 001; listed patent expiry date: 2033-09-15.
- Patent 9486426, product 001; listed patent expiry date: 2033-09-15.
- Exclusivity ODE-231, product 001; listed exclusivity date: 2025-10-26.
- Exclusivity PED, product 001; listed exclusivity date: 2026-04-26.

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

- SODIUM OXYBATE · UNII 7G33012534 · [lmmol compound XYGBKMMCQDZQOZ-UHFFFAOYSA-M](https://lmmol.com/compound/XYGBKMMCQDZQOZ-UHFFFAOYSA-M)

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/JAZZ/)
- [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:NDA021196. FDA data retrieved 2026-08-07.

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