grepcent public filings, reorganized for comparison

XYREM — FDA application NDA021196

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

Listed sponsor: JAZZ PHARMS · JAZZ 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

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001XYREMSODIUM OXYBATESOLUTIONORAL0.5GM/MLPrescriptionAAYes

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

ListingProductDescriptive dateFlags/code
Patent 10213400001listed patent expiry date: 2033-03-15U-2499
Patent 10864181001listed patent expiry date: 2033-03-15U-1532
Patent 11253494001listed patent expiry date: 2033-03-15U-3323
Patent 11253494001listed patent expiry date: 2033-03-15U-3324
Patent 11986446001listed patent expiry date: 2033-03-15U-3324
Patent 8772306001listed patent expiry date: 2033-03-15U-1532
Patent 9050302001listed patent expiry date: 2033-03-15U-1532
Patent 9486426001listed patent expiry date: 2033-03-15U-1532
Patent 10213400001listed patent expiry date: 2033-09-15pediatric extension
Patent 10864181001listed patent expiry date: 2033-09-15pediatric extension
Patent 11253494001listed patent expiry date: 2033-09-15pediatric extension
Patent 8772306001listed patent expiry date: 2033-09-15pediatric extension
Patent 9050302001listed patent expiry date: 2033-09-15pediatric extension
Patent 9486426001listed patent expiry date: 2033-09-15pediatric extension
Exclusivity ODE-231001listed exclusivity date: 2025-10-26FDA code as listed
Exclusivity PED001listed exclusivity date: 2026-04-26FDA code as listed
NDA021196 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021196 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021196 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002002-07-171.002025-10-261.002026-04-261.002033-03-151.002033-09-151.00

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

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.