FDA Orange Book
Generic for Tecfidera
Tecfidera contains dimethyl. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tecfidera is dimethyl. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tecfidera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | 120MG | Marketed (Rx) | AB | 12 | AB |
| capsule, delayed release, oral | 240MG | Marketed (Rx) | AB | 12 | AB |
NDA 204063, held by BIOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dimethyl
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 210499 | AB (A-rated, therapeutically equivalent) | September 24, 2020 | 120MG, 240MG |
| ALKEM LABORATORIES LTD | 210440 | AB (A-rated, therapeutically equivalent) | September 24, 2020 | 120MG, 240MG |
| AMNEAL EU LTD | 210402 | AB (A-rated, therapeutically equivalent) | September 24, 2020 | 120MG, 240MG |
| HETERO LABS LTD UNIT III | 210500 | AB (A-rated, therapeutically equivalent) | September 24, 2020 | 120MG, 240MG |
| MSN LABORATORIES PRIVATE LTD | 210460 | AB (A-rated, therapeutically equivalent) | September 24, 2020 | 120MG, 240MG |
| LUPIN INC | 210226 | AB (A-rated, therapeutically equivalent) | October 5, 2020 | 120MG, 240MG |
| GLENMARK PHARMACEUTICALS LTD | 210309 | AB (A-rated, therapeutically equivalent) | October 6, 2020 | 120MG, 240MG |
| TWI PHARMACEUTICALS INC | 210382 | AB (A-rated, therapeutically equivalent) | October 14, 2020 | 120MG, 240MG |
| SOLA PHARMACEUTICALS | 210436 | AB (A-rated, therapeutically equivalent) | March 26, 2021 | 120MG, 240MG |
| PRINSTON PHARMACEUTICAL INC | 210414 | AB (A-rated, therapeutically equivalent) | October 18, 2022 | 120MG, 240MG |
| AUROBINDO PHARMA LTD | 210385 | AB (A-rated, therapeutically equivalent) | December 22, 2022 | 120MG, 240MG |
| MACLEODS PHARMACEUTICALS LTD | 210377 | AB (A-rated, therapeutically equivalent) | June 26, 2024 | 120MG, 240MG |
Tecfidera patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8399514 | February 7, 2028 | Method of use | U-1384 | 204063 |
| 10391160 | March 13, 2035 | Method of use | U-3148 | 204063 |
| 10555993 | March 13, 2035 | Method of use | U-3148 | 204063 |
| 10994003 | March 13, 2035 | Method of use | U-3148 | 204063 |
| 10959972 | November 16, 2035 | Method of use | U-1384 | 204063 |
| 11129806 | November 16, 2035 | Method of use | U-1384 | 204063 |
| 11007166 | November 16, 2035 | Method of use | U-1384 | 204063 |
| 11007167 | November 16, 2035 | Method of use | U-1384 | 204063 |
| 11246850 | November 16, 2035 | Method of use | U-1384 | 204063 |
Tecfidera NDC codes
Questions
Is there a generic for Tecfidera?
Yes. The generic name for Tecfidera is dimethyl. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Tecfidera?
The active ingredient in Tecfidera is dimethyl, per the FDA Orange Book.
When does the Tecfidera patent expire?
The last patent listed for Tecfidera in the Orange Book expires November 16, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.