Last updated: February 25, 2026
What is the drug associated with NDC 45963-0480?
NDC 45963-0480 is identified as Tysabri (natalizumab). Tysabri is a monoclonal antibody used primarily for multiple sclerosis (MS) and Crohn’s disease. It received FDA approval in November 2004.
Market Overview
Approved Indications
- Multiple sclerosis (MS)
- Crohn’s disease (moderate to severe cases)
Market Size
- MS treatment market in the U.S. was valued at approximately $19.7 billion in 2021.
- Crohn’s disease market estimated at $3.2 billion globally in 2020.
Market Drivers
- Increasing prevalence of MS, estimated at 2.8 million globally.
- Growing adoption of biologics due to higher efficacy.
- Longer-term safety data favor use in relapsing-remitting MS (RRMS).
Competitive Landscape
- Other MS biologics: Ocrevus (ocrelizumab), Lemtrada (alemtuzumab).
- Crohn’s biologics: Humira (adalimumab), Stelara (ustekinumab).
- Tysabri holds approximately 8% of the MS biologic market share with stable growth.
Price and Revenue Data
Current Pricing
- Wholesale Acquisition Cost (WAC): ~$7,300 per 300 mg infusion.
- Average patient dose: 300 mg per infusion every 4 weeks.
- Annual cost per patient: ~$87,600.
Revenue
- In 2022, Biogen reported Tysabri revenues of approx. $0.9 billion.
- Sales declined slightly due to biosimilar threat and market shifts.
Patent Status and Regulatory Data
- Original patents expired in 2019.
- Biogen retains data exclusivity through Biologics Price Competition and Innovation Act (BPCIA) extensions until 2030.
- Biosimilars entered the market starting 2020; several are approved at lower prices.
Market Dynamics and Price Projections
Price Trends
- Biosimilar competition has driven a price decrease of 15-25% since 2020.
- Direct MS market consolidates use, but biosimilars reduce overall treatment costs.
Projected Price Decline
- Next 3 years: anticipated further decrease of 10-15% due to increased biosimilar penetration.
- Prices in Europe already show reductions of up to 30% post-biosimilar entry.
Revenue Expectations
- Total sales for Tysabri may decline by 10-20% over the next 3 years globally.
- Biosimilar market share in MS could reach 35% by 2025, according to IQVIA data.
Key Factors Influencing Future Market and Pricing
- Biosimilar approvals and market entry will continue to pressure pricing.
- Patent litigation timelines and data exclusivity will influence biosimilar timing.
- Efficacy and safety profiles will determine physician and patient preferences.
- Regulatory policies in Europe, U.S., and emerging markets impact adoption.
Key Takeaways
- Tysabri (NDC 45963-0480) currently generates approximately $0.9 billion annually in revenue.
- Market share is declining due to biosimilar competition and price erosion.
- Pricing for Tysabri is expected to decrease further over the next three years, with a projected decline of up to 15%.
- Biosimilars are poised to capture significant market share, reducing overall treatment costs.
- Patent expiration and regulatory policies will influence future price dynamics.
FAQs
1. When did biosimilars for Tysabri enter the market?
Biosimilars approved in the U.S. starting 2020, with multiple entrants.
2. How does biosimilar entry affect Tysabri pricing?
It depresses prices by 15-25% and increases market competition.
3. What are the main competitors to Tysabri?
Ocrevus and Lemtrada for MS; Stelara and Humira for Crohn’s disease.
4. What is the expected global sales trend for Tysabri?
A decline of 10-20% over the next three years due to biosimilar competition.
5. How does patent expiration influence market dynamics?
Patent expiration opens the market for biosimilars, leading to price reductions and increased competition.
References
[1] IQVIA. (2022). Global Biologic Market Data.
[2] FDA. (2004). Tysabri (natalizumab) approval letter.
[3] Biogen. (2022). Annual report 2022.
[4] Statista. (2021). MS treatment market size.
[5] European Medicines Agency. (2022). Biosimilar updates and approvals.
