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VYALEV

NDA

FOSCARBIDOPA; FOSLEVODOPA | N216962 | ABBVIE INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

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Today

Oct. 21, 2035

Oct. 21, 2035

Oct. 21, 2035

Jun. 10, 2040

Oct. 16, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa in Belgium NCT07382440	—	Recruiting	AbbVie	120	2026-03-09 → 2028-09
A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa NCT07284342	—	Recruiting	AbbVie	103	2025-11-17 → 2027-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2026	SUPPL -7	View Letter (PDF)
Oct 17, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)

RLD

4 patents1 exclusivity▴

SOLUTION;SUBCUTANEOUS | Approved: Oct 16, 2024

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9446059	Oct 21, 2035	—	Yes	Yes		—
10174061	Oct 21, 2035	—	—	Yes		—
10730895	Oct 21, 2035	—	Yes	—	—	—
12251365	Jun 10, 2040	—	—	—		—

Exclusivities (1)

Code	Date	Status
NP	Oct 16, 2027	Active