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Data / Drug companies / Dimethyl fumarate

Dimethyl fumarate: 20 companies and 46 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Dimethyl fumarate is listed in the FDA National Drug Code Directory by 20 companies, with 46 products in commercial distribution. 43 of the products (93.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, delayed release; kit; capsule, and the newest product started marketing on June 27, 2025.

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Companies listing it
20
Products
46
Generic (ANDA) products
43 (93.5%)
Application numbers
13
Routes
Oral
Brand names
Tecfidera, Tecfidera
openFDA record search
api.fda.gov

Companies that list dimethyl fumarate

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Macleods Pharmaceuticals Limited4kit; capsule, delayed releaseGeneric drugs (ANDA)June 27, 2025
Amneal Pharmaceuticals NY LLC3capsule, delayed release; kitGeneric drugs (ANDA)September 28, 2020
Ascend Laboratories, LLC3capsule, delayed release; kitGeneric drugs (ANDA)September 26, 2020
Biogen Inc.3capsule; kitNew drug applications (NDA)March 27, 2013
Camber Pharmaceuticals, Inc.3capsule, delayed release; kitGeneric drugs (ANDA)September 24, 2020
Cipla USA Inc.3capsule, delayed release; kitGeneric drugs (ANDA)September 24, 2020
MSN Laboratories Private Limited3capsule, delayed release; kitGeneric drugs (ANDA)May 20, 2021
Accord Healthcare Inc.2capsule, delayed releaseGeneric drugs (ANDA)January 25, 2021
Aurobindo Pharma Limited2capsule, delayed releaseGeneric drugs (ANDA)December 22, 2022
CivicaScript LLC2capsule, delayed releaseGeneric drugs (ANDA)June 11, 2025
Dr. Reddy's Laboratories Inc.2capsule, delayed releaseGeneric drugs (ANDA)September 25, 2020
Golden State Medical Supply, Inc.2capsule, delayed releaseGeneric drugs (ANDA)December 22, 2022
Golden State Medical Supply, Inc.2capsule, delayed releaseGeneric drugs (ANDA)October 14, 2020
Sola Pharmaceuticals, LLC2capsule, delayed releaseGeneric drugs (ANDA)January 31, 2023
Solco Healthcare US, LLC2capsule, delayed releaseGeneric drugs (ANDA)October 18, 2022
Upsher-Smith Laboratories, LLC2capsule, delayed releaseGeneric drugs (ANDA)December 1, 2020
Zydus Lifesciences Limited2capsule, delayed releaseGeneric drugs (ANDA)September 28, 2020
Zydus Pharmaceuticals USA Inc.2capsule, delayed releaseGeneric drugs (ANDA)September 28, 2020
A-S Medication Solutions1capsule, delayed releaseGeneric drugs (ANDA)September 24, 2020
Quallent Pharmaceuticals Health LLC1capsule, delayed releaseGeneric drugs (ANDA)June 15, 2024

Dosage forms

Dosage formProductsShare
Capsule, delayed release3678.3%
Kit817.4%
Capsule24.3%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)4393.5%
New drug applications (NDA)36.5%

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.