BAFIERTAM

Peak

monomethyl fumarate

NDAORALCAPSULE, DELAYED RELEASE
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1

Mechanism of Action

(MMF) exerts its therapeutic effect in multiple sclerosis is unknown. MMF has been shown to activate the Nuclear factor (erythroid-derived 2) like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been…

Indications (5)

relapsing forms of multiple sclerosis (MS)to include clinically isolated syndromerelapsing-remitting diseaseactive secondary progressive diseasemultiple sclerosis

Clinical Trials (1)

NCT02201849Phase 1Completed

A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults

Started Jul 2014
104 enrolled
Multiple Sclerosis

Loss of Exclusivity

LOE Date
Feb 27, 2035
109 months away
Patent Expiry
Feb 27, 2035

Patent Records (5)

Patent #ExpiryTypeUse Code
10098863
Feb 27, 2035
Product
U-1384
10105335
Feb 27, 2035
Product
—
10105336
Feb 27, 2035
Product
U-1384
10105337
Feb 27, 2035
Product
—
10918615
Feb 27, 2035
Product
U-1384
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers