FDA Orange Book

Generic for Vumerity

Vumerity contains diroximel. 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 Vumerity is diroximel. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Vumerity products in the Orange Book

Vumerity products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, delayed release, oral231MGMarketed (Rx)AB1AB

NDA 211855, 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 diroximel

Approved generic versions of Vumerity
CompanyANDATE codeApprovedStrengths
ZYDUS WORLDWIDE DMCC218596AB (A-rated, therapeutically equivalent)November 12, 2025231MG

Vumerity patents

Patents listed for Vumerity
PatentExpiresCoversUse codeNDA
9090558September 20, 2033Method of useU-1384211855
10080733September 20, 2033Drug substance, Drug productU-1384211855
8669281October 29, 2033Drug substance, Drug productNone211855

Vumerity NDC codes

Questions

Is there a generic for Vumerity?

Yes. The generic name for Vumerity is diroximel. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Vumerity?

The active ingredient in Vumerity is diroximel, per the FDA Orange Book.

When does the Vumerity patent expire?

The last patent listed for Vumerity in the Orange Book expires October 29, 2033. 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.

More on Vumerity and Diroximel

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