FDA Orange Book · active-ingredient family
Dimethyl fumarate
Dimethyl fumarate is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TECFIDERA · NDA 204063
1
Brand (NDA)
17
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TECFIDERARLD×2 | BIOGEN | NDA 204063 | AB | Mar 27, 2013 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIMETHYL FUMARATE×2 | TORRENT | ANDA 210390 | — | Jan 06, 2025 | |
| DIMETHYL FUMARATE×2 | MACLEODS PHARMS LTD | ANDA 210377 | AB | Jun 26, 2024 | |
| DIMETHYL FUMARATE×2 | AUROBINDO PHARMA | ANDA 210385 | AB | Dec 22, 2022 | |
| DIMETHYL FUMARATE×2 | PRINSTON INC | ANDA 210414 | AB | Oct 18, 2022 | |
| DIMETHYL FUMARATE×2 | SAWAI USA | ANDA 210285 | — | Dec 21, 2021 | |
| DIMETHYL FUMARATE×2 | SOLA PHARMS | ANDA 210436 | AB | Mar 26, 2021 | |
| DIMETHYL FUMARATE×2 | TWI PHARMS | ANDA 210382 | AB | Oct 14, 2020 | |
| DIMETHYL FUMARATE×2 | GLENMARK PHARMS LTD | ANDA 210309 | AB | Oct 06, 2020 | |
| DIMETHYL FUMARATE×2 | LUPIN | ANDA 210226 | AB | Oct 05, 2020 | |
| DIMETHYL FUMARATE×2 | ACCORD HLTHCARE | ANDA 210499 | AB | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | ALKEM LABS LTD | ANDA 210440 | AB | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | AMNEAL | ANDA 210402 | AB | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | CIPLA | ANDA 210305 | — | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | HETERO LABS LTD III | ANDA 210500 | AB | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | MSN | ANDA 210460 | AB | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | ZYDUS PHARMS | ANDA 210538 | — | Sep 24, 2020 | |
| DIMETHYL FUMARATE×2 | MYLAN | ANDA 210531 | — | Aug 17, 2020 |
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 |
| 11129806 | 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 |
| 11246850 | Nov 16, 2035 | in 9 yr 7 mo | U-1384 |
Dimethyl fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
