grepcent public filings, reorganized for comparison

XELJANZ XR — FDA application NDA208246

Application NDA208246 · type NDA · FDA status: approved · original approval 2016-02-23

Listed sponsor: PFIZER · PFE 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
001XELJANZ XRTOFACITINIB CITRATETABLET, EXTENDED RELEASEORALEQ 11MG BASEPrescriptionABYes
002XELJANZ XRTOFACITINIB CITRATETABLET, EXTENDED RELEASEORALEQ 22MG BASEPrescriptionABYes

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 RE41783001listed patent expiry date: 2025-12-08drug substance
Patent RE41783002listed patent expiry date: 2025-12-08drug substance
Patent RE41783001listed patent expiry date: 2026-06-08pediatric extension
Patent RE41783002listed patent expiry date: 2026-06-08pediatric extension
Patent 10639309002listed patent expiry date: 2034-03-14drug product
Patent 11253523001listed patent expiry date: 2034-03-14U-3326
Patent 11253523001listed patent expiry date: 2034-03-14U-3327
Patent 11253523001listed patent expiry date: 2034-03-14U-3328
Patent 11253523001listed patent expiry date: 2034-03-14U-3329
Patent 11253523002listed patent expiry date: 2034-03-14U-3326
Patent 11253523002listed patent expiry date: 2034-03-14U-3327
Patent 11253523002listed patent expiry date: 2034-03-14U-3328
Patent 11253523002listed patent expiry date: 2034-03-14U-3329
Patent 9937181001listed patent expiry date: 2034-03-14drug product
Patent 10639309002listed patent expiry date: 2034-09-14pediatric extension
Patent 11253523001listed patent expiry date: 2034-09-14pediatric extension
Patent 11253523002listed patent expiry date: 2034-09-14pediatric extension
Patent 9937181001listed patent expiry date: 2034-09-14pediatric extension
NDA208246 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208246 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208246 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 marker0.001.002.002016-02-231.002025-12-081.002026-06-081.002034-03-141.002034-09-141.00

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: Large-cap biopharma

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.