Orange Book product · Brand (NDA)
BAFIERTAM
MONOMETHYL FUMARATE
At a glance
Apr 28, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
21
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2020
6 yr 3 mo ago
Today
Patent 10098863 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10105335 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10105336 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10105337 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10918615 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10918616 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10918617 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 10945985 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 11590095 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 11903918 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9326947 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9326965 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9511043 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9517209 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9566259 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9636318 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9636319 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9814691 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9814692 expires
Listed method-of-use patent (U-1384) expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9820960 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Patent 9820961 expires
Listed drug product patent expiration.
Feb 27, 2035
in 8 yr 10 mo
Pharmaceutical detail
Active ingredient
MONOMETHYL FUMARATE
Strength
95MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 210296
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10098863 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 10105335 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10105336 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 10105337 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10918615 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
| 10918616 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 10918617 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 10945985 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 11590095 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 11903918 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9326947 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9326965 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9511043 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9517209 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9566259 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9636318 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9636319 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9814691 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9814692 | Feb 27, 2035 | in 8 yr 10 mo | U-1384 |
| 9820960 | Feb 27, 2035 | in 8 yr 10 mo | Product |
| 9820961 | Feb 27, 2035 | in 8 yr 10 mo | ProductU-1384 |
