XELJANZ — FDA application NDA213082

Application NDA213082 · type NDA · FDA status: approved · original approval 2020-09-25

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

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	XELJANZ	TOFACITINIB CITRATE	SOLUTION	ORAL	EQ 1MG BASE/ML	Prescription	AA	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.

Listing	Product	Descriptive date	Flags/code
Patent RE41783	001	listed patent expiry date: 2025-12-08	drug substance
Patent RE41783	001	listed patent expiry date: 2026-06-08	pediatric extension
Exclusivity M-14	001	listed exclusivity date: 2028-02-21	FDA code as listed
Exclusivity PED	001	listed exclusivity date: 2028-08-21	FDA code as listed

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

TOFACITINIB CITRATE · UNII O1FF4DIV0D · lmmol compound SYIKUFDOYJFGBQ-YLAFAASESA-N · CHEMBL2103743

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

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.