FDA — authorised 27 March 2013
- Application: NDA204063
- Marketing authorisation holder: BIOGEN INC
- Local brand name: TECFIDERA
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Tecfidera in United States
FDA authorised Tecfidera on 27 March 2013
Marketing authorisations
FDA — authorised 27 March 2013
- Marketing authorisation holder: BIOGEN IDEC INC
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210460
- Marketing authorisation holder: MSN
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210305
- Marketing authorisation holder: CIPLA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210402
- Marketing authorisation holder: AMNEAL
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA210440
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 October 2020
- Application: ANDA210309
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 14 October 2020
- Application: ANDA210382
- Marketing authorisation holder: TWI PHARMS
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 March 2021
- Application: ANDA210436
- Marketing authorisation holder: SOLA PHARMS
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 21 December 2021
- Application: ANDA210285
- Marketing authorisation holder: SAWAI USA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 2022
- Application: ANDA210414
- Marketing authorisation holder: PRINSTON INC
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2022
- Application: ANDA210385
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 June 2024
- Application: ANDA210377
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 6 January 2025
- Application: ANDA210390
- Marketing authorisation holder: TORRENT
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA210291
- Marketing authorisation holder: SHILPA MEDICARE LTD
- Local brand name: DIMETHYL FUMARATE
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
Tecfidera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Tecfidera approved in United States?
Yes. FDA authorised it on 27 March 2013; FDA authorised it on 27 March 2013; FDA authorised it on 24 September 2020.
Who is the marketing authorisation holder for Tecfidera in United States?
BIOGEN INC holds the US marketing authorisation.