Orange Book product · Brand (NDA)
TECFIDERA
DIMETHYL FUMARATE
At a glance
Mar 27, 2013
Approved
Brand (NDA)
Application
AB
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 27, 2013
13 yr 5 mo ago
Today
Patent 8399514 expires
Listed method-of-use patent (U-1384) expiration.
Feb 07, 2028
in 1 yr 8 mo
Patent 10391160 expires
Listed method-of-use patent (U-3148) expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10555993 expires
Listed method-of-use patent (U-3148) expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10994003 expires
Listed method-of-use patent (U-3148) expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 10959972 expires
Listed method-of-use patent (U-1384) expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 11007166 expires
Listed method-of-use patent (U-1384) expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 11007167 expires
Listed method-of-use patent (U-1384) expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 11129806 expires
Listed method-of-use patent (U-1384) expiration.
Nov 16, 2035
in 9 yr 7 mo
Patent 11246850 expires
Listed method-of-use patent (U-1384) expiration.
Nov 16, 2035
in 9 yr 7 mo
Pharmaceutical detail
Active ingredient
DIMETHYL FUMARATE
Strength
120MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 204063
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210390 · TORRENT
- 2024DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210377 · MACLEODS PHARMS LTD
- 2022DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210385 · AUROBINDO PHARMA
- 2022DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210414 · PRINSTON INC
- 2021DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210285 · SAWAI USA
- 2021DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210436 · SOLA PHARMS
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210382 · TWI PHARMS
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210309 · GLENMARK PHARMS LTD
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210226 · LUPIN
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210499 · ACCORD HLTHCARE
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210440 · ALKEM LABS LTD
- 2020DIMETHYL FUMARATEGeneric (ANDA)
ANDA 210402 · AMNEAL
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8399514 | Feb 07, 2028 | in 1 yr 8 mo | U-1384 |
| 10391160 | Mar 13, 2035 | in 8 yr 10 mo | U-3148 |
| 10555993 | Mar 13, 2035 | in 8 yr 10 mo | U-3148 |
| 10994003 | Mar 13, 2035 | in 8 yr 10 mo | U-3148 |
| 10959972 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
| 11007166 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
| 11007167 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
| 11129806 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
| 11246850 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
