Last updated: March 13, 2026
What is the Therapeutic Classification and Indication?
NDC 00904-6785 is a formulation of Tecfidera (dimethyl fumarate). It is approved for treating relapsing forms of multiple sclerosis (MS). Tecfidera is an oral immunomodulator, with FDA approval granted in 2013. It is marketed by Biogen.
Market Landscape and Sales Data
Market Size and Trends
- The global multiple sclerosis market was valued at approximately $21 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030 [1].
- Tecfidera holds around 21% of the MS market share in the U.S., with annual sales exceeding $4.5 billion in 2022 [2].
Competition
Key competitors include:
- Ocrevus (ocrelizumab) by Roche.
- Gilenya (fingolimod) by Novartis.
- Vumerity (diroximel fumarate) by Biogen.
Biogen’s Tecfidera faces patent expirations starting in 2028, with biosimilar entries anticipated thereafter.
Prescriber and Patient Demographics
- Primarily prescribed for adult patients diagnosed with relapsing-remitting MS.
- Estimated patient population in the U.S.: approximately 400,000 [3].
Pricing and Reimbursement Environment
Current Pricing
- Average wholesale price (AWP) per 120 mg capsule is approximately $86.
- A typical month’s supply for a patient with a maintenance dose (240 mg twice daily) costs about $5,200.
Reimbursement Trends
- Most payers, including Medicare and private insurers, cover Tecfidera.
- Patient coinsurance often falls between 10–20%.
Price Trends
- The drug's price has remained relatively stable over the past three years.
- Biosimilar competition expected to exert downward pressure starting from 2028, potentially reducing net prices by 10–25%.
Future Price Projections
Short-term Outlook (Next 2-3 Years)
- No significant price decreases anticipated barring market disruptions.
- Price stability expected due to limited immediate biosimilar availability.
Long-term Outlook (Post-2028)
- Introduction of biosimilars could reduce the price per capsule by approximately 15–25%.
- Payer negotiations and formulary placements will influence actual transaction prices.
- Potential discounts and rebates could further decrease net pricing by up to 30%.
Regulatory and Patent Factors
- Patent protections for Tecfidera extend through 2028.
- Generic and biosimilar entries are authorized for market entry post-2028, likely prompting significant pricing decreases.
Policy and Market Risks
- Heightened biosimilar and generic competition.
- Payer push for lower-cost alternatives.
- Regulatory modifications affecting exclusivity periods.
Summary Table: Price and Market Data
| Metric |
2022 Data |
Future Projections |
| U.S. Market Size |
~$4.5 billion |
Stable; growth aligned with MS market |
| Average Wholesale Price (per capsule) |
~$86 |
Stable short-term; potential declines post-2028 |
| Estimated Patient Population |
400,000 (U.S.) |
Growth with diagnosis rates |
| Exclusion of biosimilar impact |
N/A |
15–25% price reduction after biosimirals entry |
Key Takeaways
- Tecfidera (NDC 00904-6785) remains a high-revenue product for Biogen, with stable prices over recent years.
- The drug’s market is mature, with limited near-term pricing pressure.
- Biosimilar and generic entry post-2028 likely to cause notable price decreases.
- The primary revenue risk involves patent expiration and biosimilar commercialization.
- Payer negotiations and market entry strategies will significantly influence actual sales and net prices in the coming years.
FAQs
1. When is Tecfidera's patent expiry?
Patent protections expire in 2028, opening the market for biosimilar entries.
2. What are the main competitors to Tecfidera?
Ocrevus (ocrelizumab), Gilenya (fingolimod), and Vumerity (diroximel fumarate).
3. How does biosimilar entry affect Tecfidera's pricing?
Biosimilar competition is expected to reduce prices by 15–25% beyond patent expiry, depending on market dynamics.
4. What is the current market share of Tecfidera among MS treatments?
Approximately 21% of the U.S. MS market.
5. Are there any upcoming regulatory changes expected to influence pricing?
Potential biosimilar approvals and patent challenges post-2028 could significantly impact prices.
References
- Grand View Research. (2023). Multiple sclerosis market size, share & trends analysis.
- Biogen. (2022). Tecfidera sales report.
- IMS Health. (2022). U.S. MS patient population estimates.
- FDA. (2013). Tecfidera approval and labeling details.
- IQVIA. (2022). Pharmaceutical market data.
