FDA Orange Book · active-ingredient family
Monomethyl fumarate
Monomethyl fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BAFIERTAM · NDA 210296
1
Brand (NDA)
0
Generics (ANDA)
21
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BAFIERTAMRLD | BANNER LIFE SCIENCES | NDA 210296 | — | Apr 28, 2020 |
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11903918 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 10918615 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 10918616 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 11590095 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9511043 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9326965 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9814692 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9636318 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9814691 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 10105336 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 9820961 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 10098863 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 9517209 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9566259 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9326947 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10105335 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10105337 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10918617 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9636319 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10945985 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9820960 | Feb 27, 2035 | in 8 yr 10 mo | Product |
Monomethyl fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
