VYALEV — FDA application NDA216962

Application NDA216962 · type NDA · FDA status: approved · original approval 2024-10-16

Listed sponsor: ABBVIE · ABBV 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	VYALEV	FOSCARBIDOPA; FOSLEVODOPA	SOLUTION	SUBCUTANEOUS	120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)	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 10174061	001	listed patent expiry date: 2035-10-21	drug product, U-4030
Patent 10730895	001	listed patent expiry date: 2035-10-21	drug substance
Patent 9446059	001	listed patent expiry date: 2035-10-21	drug substance, drug product, U-4030
Patent 12251365	001	listed patent expiry date: 2040-06-10	U-4030
Exclusivity NP	001	listed exclusivity date: 2027-10-16	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.

FOSCARBIDOPA · UNII 5NT8HCA4OO · lmmol compound PQUZXFMHVSMUNG-JTQLQIEISA-N · CHEMBL4802240
FOSLEVODOPA · UNII 37NQZ0J76I · lmmol compound YNDMEEULGSTYJT-LURJTMIESA-N · CHEMBL4594379

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.