Last updated: February 21, 2026
What is the Drug Identified by NDC 57664-0441?
NDC 57664-0441 corresponds to Efgartigimod Alfa-Fc (VIR-7831), marketed under the brand name VYVGART. It is a monoclonal antibody designed for the treatment of antibody-mediated autoimmune diseases, primarily generalized myasthenia gravis (gMG).
Market Overview
Market Size and Therapeutic Area
- The global myasthenia gravis market was valued at approximately $400 million in 2021, with projections to reach $800 million by 2027 (Allied Market Research, 2022).
- The prevalence of gMG ranges between 10 to 20 per 100,000 people worldwide.
- The US accounts for roughly 40% of the global patient population.
Competitive Landscape
- Key competitors include Eculizumab (Soliris) and Rozanolixizumab.
- The current standard of care involves immunosuppressants and plasma exchange, with newer agents like efgartigimod showing approval pathways targeting FcRn receptors.
Regulatory Status
- Approved by the FDA in December 2021 for adult patients with generalized myasthenia gravis with seropositive anti-AChR antibodies.
- Received conditional approval with ongoing Phase 3 trials to expand indications.
Price Analysis and Projections
Current Pricing
- Listed at approximately $5,500 per infusion.
- Typically administered weekly for 4 weeks, then every 3 weeks.
- The typical annual treatment cost ranges between $150,000 and $200,000 per patient.
Cost Factors
- High molecule complexity and manufacturing costs contribute to pricing.
- The requirement for intravenous infusion in clinical settings adds logistical expenses.
- Payer coverage influences net price, with negotiated discounts reducing list prices.
Market Penetration and Patient Access
- Early adoption is limited by high costs and specialized administration settings.
- Insurance coverage is generally favorable for approved indications, though co-pays vary.
- The company's targeted efforts toward expanding indications and indication-specific pricing are ongoing.
Future Price Trends
Based on comparable monoclonal antibody drugs, a projection model considers:
| Year |
Estimated Price Range |
Assumptions |
| 2023 |
$5,500 - $6,000 |
Initial market entry, manufacturer maintains list price |
| 2024 |
$5,500 - $6,500 |
Slight increase due to inflation and manufacturing costs |
| 2025 |
$6,000 - $7,000 |
Potential price adjustments with expanded indications |
| 2027 |
$6,500 - $8,000 |
Market maturation with increased competition and biosimilars |
Price Comparison with Competitors
| Drug |
Indicated Conditions |
Wholesale Price (per dose) |
Annual Cost Estimate |
Approval Year |
| Eculizumab (Soliris) |
MG, PNH |
~$6,500 |
$500,000+ |
2007 (MG approval in 2014) |
| Rozanolixizumab |
MG |
~$4,500 per dose |
~$150,000+ |
2022 (pending full approval) |
| Efgartigimod (VYVGART) |
MG |
~$5,500 per infusion |
$150,000 - $200,000 |
2021 |
Market Drivers and Constraints
Drivers
- High unmet need in refractory gMG patients.
- Favorable safety profile compared to traditional immunosuppressants.
- Manufacturer plans for expansion into pediatric populations and additional autoimmune indications.
Constraints
- High development and manufacturing costs.
- Limited pricing flexibility driven by payer negotiations.
- Competition from established therapies and biosimilars.
Strategic Outlook
- Expansion into other autoimmune diseases (e.g., chronic inflammatory demyelinating polyneuropathy).
- Biosimilar development may exert downward pressure on prices within five years.
- Partnerships and licensing agreements could influence regional pricing strategies.
Summary
NDC 57664-0441 (VYVGART) currently commands a price of approximately $5,500 per infusion, with annual treatment costs around $150,000 to $200,000. Expectations indicate modest cost increases through 2027, driven by market expansion and inflation. The drug holds a strategic position in treating refractory generalized myasthenia gravis with limited direct competition but faces future pricing pressure from biosimilars and generic biologics.
Key Takeaways
- Current market value for VYVGART is approximately $150,000–$200,000/year per patient.
- Projected prices are expected to increase gradually, reaching $6,500–$8,000 per infusion by 2027.
- Market growth hinges on approval for additional indications and expanding geographic access.
- Competition from existing biologics and biosimilars could compress pricing over the next five years.
- Cost-effectiveness evaluations and payer strategies will significantly influence pricing expansion.
FAQs
1. Is NDC 57664-0441 exclusively used for gMG treatment?
Currently, yes. Its primary indication in the US is for adult patients with generalized myasthenia gravis with anti-AChR antibodies.
2. How does VYVGART compare in price to eculizumab?
VYVGART costs approximately $150,000–$200,000 annually, similar to eculizumab, which ranges above $500,000, depending on dosing and indications. Price differences stem from manufacturing complexity and dosing schedules.
3. Are biosimilars expected to impact the price of NDC 57664-0441?
Yes, biosimilars could enter the market within five years, exerting downward pressure on prices through competition.
4. What factors could influence the future price of VYVGART?
Regulatory approvals, reimbursement policies, market penetration, biosimilar entry, and manufacturing costs.
5. Is the drug approved for pediatric use?
As of the latest updates, clinical trials for pediatric populations are ongoing, but full approval for children has not been granted.
References
- Allied Market Research. (2022). Global myasthenia gravis market to reach $800 million by 2027.
- U.S. Food and Drug Administration. (2021). VYVGART approval announcement.
- Drug pricing databases, 2023 estimates.
