VUMERITY — FDA application NDA211855

Application NDA211855 · type NDA · FDA status: approved · original approval 2019-10-29

Listed sponsor: BIOGEN · BIIB 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	VUMERITY	DIROXIMEL FUMARATE	CAPSULE, DELAYED RELEASE	ORAL	231MG	Prescription	AB	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 10080733	001	listed patent expiry date: 2033-09-20	drug substance, drug product, U-1384
Patent 9090558	001	listed patent expiry date: 2033-09-20	U-1384
Patent 8669281	001	listed patent expiry date: 2033-10-29	drug substance, drug product

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

DIROXIMEL FUMARATE · UNII K0N0Z40J3W · lmmol compound YIMYDTCOUQIDMT-SNAWJCMRSA-N · CHEMBL3989944

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

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.