# VUMERITY — FDA application NDA211855

Informational only - not investment advice.

Application NDA211855 · type NDA · FDA status: approved · original approval 2019-10-29

Listed sponsor: BIOGEN · [BIIB company profile](/company/BIIB/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | VUMERITY | DIROXIMEL FUMARATE | CAPSULE, DELAYED RELEASE | ORAL | 231MG | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 10080733, product 001; listed patent expiry date: 2033-09-20.
- Patent 9090558, product 001; listed patent expiry date: 2033-09-20.
- Patent 8669281, product 001; listed patent expiry date: 2033-10-29.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- DIROXIMEL FUMARATE · UNII K0N0Z40J3W · [lmmol compound YIMYDTCOUQIDMT-SNAWJCMRSA-N](https://lmmol.com/compound/YIMYDTCOUQIDMT-SNAWJCMRSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/BIIB/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA211855. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.