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.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Macleods Pharmaceuticals Limited | 4 | kit; capsule, delayed release | Generic drugs (ANDA) | June 27, 2025 |
| Amneal Pharmaceuticals NY LLC | 3 | capsule, delayed release; kit | Generic drugs (ANDA) | September 28, 2020 |
| Ascend Laboratories, LLC | 3 | capsule, delayed release; kit | Generic drugs (ANDA) | September 26, 2020 |
| Biogen Inc. | 3 | capsule; kit | New drug applications (NDA) | March 27, 2013 |
| Camber Pharmaceuticals, Inc. | 3 | capsule, delayed release; kit | Generic drugs (ANDA) | September 24, 2020 |
| Cipla USA Inc. | 3 | capsule, delayed release; kit | Generic drugs (ANDA) | September 24, 2020 |
| MSN Laboratories Private Limited | 3 | capsule, delayed release; kit | Generic drugs (ANDA) | May 20, 2021 |
| Accord Healthcare Inc. | 2 | capsule, delayed release | Generic drugs (ANDA) | January 25, 2021 |
| Aurobindo Pharma Limited | 2 | capsule, delayed release | Generic drugs (ANDA) | December 22, 2022 |
| CivicaScript LLC | 2 | capsule, delayed release | Generic drugs (ANDA) | June 11, 2025 |
| Dr. Reddy's Laboratories Inc. | 2 | capsule, delayed release | Generic drugs (ANDA) | September 25, 2020 |
| Golden State Medical Supply, Inc. | 2 | capsule, delayed release | Generic drugs (ANDA) | December 22, 2022 |
| Golden State Medical Supply, Inc. | 2 | capsule, delayed release | Generic drugs (ANDA) | October 14, 2020 |
| Sola Pharmaceuticals, LLC | 2 | capsule, delayed release | Generic drugs (ANDA) | January 31, 2023 |
| Solco Healthcare US, LLC | 2 | capsule, delayed release | Generic drugs (ANDA) | October 18, 2022 |
| Upsher-Smith Laboratories, LLC | 2 | capsule, delayed release | Generic drugs (ANDA) | December 1, 2020 |
| Zydus Lifesciences Limited | 2 | capsule, delayed release | Generic drugs (ANDA) | September 28, 2020 |
| Zydus Pharmaceuticals USA Inc. | 2 | capsule, delayed release | Generic drugs (ANDA) | September 28, 2020 |
| A-S Medication Solutions | 1 | capsule, delayed release | Generic drugs (ANDA) | September 24, 2020 |
| Quallent Pharmaceuticals Health LLC | 1 | capsule, delayed release | Generic drugs (ANDA) | June 15, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, delayed release | 36 | 78.3% |
| Kit | 8 | 17.4% |
| Capsule | 2 | 4.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 43 | 93.5% |
| New drug applications (NDA) | 3 | 6.5% |
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.