LITFULO — FDA application NDA215830

Application NDA215830 · type NDA · FDA status: approved · original approval 2023-06-23

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

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	LITFULO	RITLECITINIB TOSYLATE	CAPSULE	ORAL	EQ 50MG BASE	Prescription	not listed	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 12077533	001	listed patent expiry date: 2034-12-03	U-3994
Patent 9617258	001	listed patent expiry date: 2034-12-03	drug substance, drug product
Patent 12116368	001	listed patent expiry date: 2041-10-17	drug substance
Exclusivity NCE	001	listed exclusivity date: 2028-06-23	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.

RITLECITINIB TOSYLATE · UNII EAG4T1459K · lmmol compound YOZLVAFWYLSRRN-VZXYPILPSA-N · CHEMBL5314649

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.