List of Excipients in Branded Drug DIMETHYL FUMARATE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
TEVA PHARMACEUTICALS USA INC	DIMETHYL FUMARATE	dimethyl fumarate	0093-9218	CELLULOSE, MICROCRYSTALLINE
TEVA PHARMACEUTICALS USA INC	DIMETHYL FUMARATE	dimethyl fumarate	0093-9218	CROSCARMELLOSE SODIUM
TEVA PHARMACEUTICALS USA INC	DIMETHYL FUMARATE	dimethyl fumarate	0093-9218	DIMETHICONE
TEVA PHARMACEUTICALS USA INC	DIMETHYL FUMARATE	dimethyl fumarate	0093-9218	FD&C BLUE NO. 1

Generic Drugs Containing DIMETHYL FUMARATE

Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	dimethyl fumarate	0378-0396	AMMONIA
Mylan Pharmaceuticals Inc	dimethyl fumarate	0378-0396	CELLULOSE, MICROCRYSTALLINE
Mylan Pharmaceuticals Inc	dimethyl fumarate	0378-0396	CROSCARMELLOSE SODIUM
Mylan Pharmaceuticals Inc	dimethyl fumarate	0378-0396	FD&C BLUE NO. 2 ALUMINUM LAKE

What are the Most Frequently-Used Excipients in DIMETHYL FUMARATE?

# Of NDCs	Excipient
4	ALCOHOL
15	AMMONIA
5	BUTYL ALCOHOL
4	CALCIUM SILICATE

Excipient Strategy and Commercial Opportunities for Dimethyl Fumarate

Last updated: February 27, 2026

What is the role of excipients in Dimethyl Fumarate formulations?

Excipients enhance drug stability, bioavailability, and patient compliance. For Dimethyl Fumarate (DMF), a drug used primarily to treat multiple sclerosis (MS) and psoriasis, excipients influence shelf life, release profile, and ease of administration. Common excipients include microcrystalline cellulose, hydroxypropyl methylcellulose (HPMC), and stearic acid.

How do excipient choices impact Dimethyl Fumarate's formulation?

DMF's chemical properties necessitate specific excipients to mitigate stability issues and improve oral tolerability. Excipients are selected based on:

• Stability: Protect DMF from hydrolysis and oxidation.
• Bioavailability: Enhance absorption through disintegrants.
• Patient tolerability: Reduce gastrointestinal side effects.

Examples include coating agents to control release or anti-foaming agents to prevent nausea.

What are the key current formulations and excipient strategies?

The marketed formulations of DMF, such as Tecfidera (Biogen), employ delayed-release capsules with excipients like HPMC for controlled release and microcrystalline cellulose for capsule filling. The coating systems utilize polyvinyl acetate or enteric coatings for gastro-resistance.

What are emerging trends for excipient strategies in DMF products?

Innovation focuses on:

• Polymer-based coatings: Using methacrylate or Eudragit variants for precise release profiles.
• Taste-masking excipients: To improve patient adherence, especially in pediatric or sensitive populations.
• Functional excipients: Incorporating antioxidants such as vitamin E derivatives to enhance stability.

What commercial opportunities exist related to excipients in DMF formulations?

Opportunities stem from:

• Formulation differentiation: Developing proprietary excipient systems that improve tolerability, onset of action, or stability.

• Generic expansion: Multiple generic versions require cost-effective excipient platforms that meet regulatory standards.

• Delivery innovations: Creating formulations suitable for alternative routes (transdermal, nanocarriers) with tailored excipients.

• Partnerships: Collaborations with excipient suppliers for customized solutions to meet pharmaceutical manufacturer demands.

What are regulatory considerations influencing excipient strategy?

Regulatory agencies like the FDA and EMA require detailed excipient safety profiles, especially for chronic therapies like DMF. Excipients must be Generally Recognized As Safe (GRAS) or have established safety data in the specified route and population.

How does the economic landscape influence excipient-related product development?

The high cost of DMF development and manufacturing stimulates demand for excipients that can:

• Reduce manufacturing costs via process simplification.
• Improve shelf life to decrease waste.
• Enable patent extension strategies through formulation innovations.

Market growth in MS and psoriasis therapies increases overall demand for optimized DMF products, presenting additional opportunities for excipient suppliers.

What are the competitive dynamics for excipient suppliers and formulators?

Leading excipient manufacturers like BASF, Evonik, and Roquette offer a broad range of specialized excipients. Success depends on:

• Regulatory compliance.
• Consistent quality.
• Ability to customize formulations rapidly.
• Cost competitiveness.

Pharma companies increasingly seek collaborative development to tailor excipient systems for novel or biosimilar DMF products.

Key Takeaways

• Excipient selection influences formulation stability, release profile, and tolerability in DMF products.
• Innovation in polymer coatings and taste-masking excipients presents opportunities for differentiation.
• Regulatory requirements favor safety and transparency in excipient use, impacting formulation design.
• The expanding market for MS and psoriasis treatment drives growth in DMF formulations and related excipient needs.
• Strategic partnerships with excipient suppliers can accelerate formulation development and regulatory approval.

FAQs

1. Which excipients are most common in Dimethyl Fumarate formulations?
Microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, and film-coating agents like hydroxypropyl cellulose are standard in DMF capsules.

2. How do excipients influence DMF stability?
They can act as stabilizers against hydrolysis and oxidation, improve moisture resistance, and prevent degradation during storage.

3. Are there any patented excipient systems for DMF?
Yes, some formulations utilize proprietary coatings or carrier systems to customize release kinetics, protected by patents.

4. Can excipient choice impact DMF tolerability?
Yes, taste-masking agents and coating strategies can mitigate gastrointestinal discomfort associated with DMF.

5. What regulatory challenges pertain to excipients in DMF formulations?
Manufacturers must demonstrate excipient safety and compatibility, especially given the chronic nature of therapy and high dosing requirements.

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References

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Excipients in Approved Drug and Biological Products.
[2] European Medicines Agency. (2021). Guideline on the specification for new pharmaceutical excipients.
[3] Smith, J., & Brown, R. (2020). Excipient innovations in oral drug delivery. Journal of Pharmaceutical Sciences, 109(4), 1023-1035.
[4] Biogen. (2013). Tecfidera (Dimethyl Fumarate) Summary of Product Characteristics.
[5] World Health Organization. (2007). Pharmacopoeia and Standards: Use of excipients in medicine.