FDA Orange Book · active-ingredient family
Diroximel fumarate
Diroximel fumarate: 1 brand, 1 generic; first approved Oct 29, 2019; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
3
Next patent expiry
Sep 20, 2033
in 7 yr
Brand (NDA) products
Originator applications
- BIOGENNDA 2118552019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 231MG CAPSULE, DELAYED RELEASE ORAL Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- DIROXIMEL FUMARATEZYDUSANDA 2185962025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 231MG CAPSULE, DELAYED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9090558 | in 7 yr | U-1384 | |
| 10080733 | in 7 yr | SubstanceProductU-1384 | |
| 8669281 | in 7 yr 2 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
7 yr 1 mo ago
Most recent approval
11 mo ago
Approvals span 2019–2025 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Diroximel fumarate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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