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DIROXIMEL FUMARATE

ANDA

DIROXIMEL FUMARATE | A218596 | ZYDUS WORLDWIDE DMCC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VUMERITY(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Biogen Inc. et al v. Zydus Worldwide DMCC et al 1:2023cv00732 3 patentsANDA 218596diroximel fumarate	D. Del.	2023-07-06	Terminated 2025-08-13	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

STERLING PHARMA SOLUTIONS LTDDIROXIMEL FUMARATE DRUG SUBSTANCE

DMF 329772018

TAPI NL BVDIROXIMEL FUMARATE

DMF 337522019

INTAS PHARMACEUTICALS LTDDIROXIMEL FUMARATE

DMF 346772020

ZYDUS LIFESCIENCES LTDDIROXIMEL FUMARATE

DMF 353732020

ALIVUS LIFE SCIENCES LTDDIROXIMEL FUMARATE

DMF 357852021

DR REDDYS LABORATORIES LTDDIROXIMEL FUMARATE

DMF 357932021

HONOUR LAB LTDDIROXIMEL FUMARATE

DMF 360192021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 13, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 231MG

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Nov 12, 2025

No patent or exclusivity listings for this strength.