Last updated: February 27, 2026
What is NDC 72572-0055?
NDC 72572-0055 corresponds to the drug Efgartigimod alfa-fcab marketed by Scaffold Biotech under its brand name Vyvgart. It is an Fc fragment humanized antibody used for the treatment of generalized myasthenia gravis (gMG).
Market Overview
Indications and Approved Uses
Vyvgart is approved by the U.S. Food and Drug Administration (FDA) since December 2021 for:
- Generalized myasthenia gravis (gMG) in adults.
- MuSK antibody-positive gMG in adults.
- Pediatric patients aged 2 years and older with gMG at risk of progression.
Market Size and Growth Drivers
The global gMG market was valued at approximately $180 million in 2022, with expectations to reach $400 million by 2030 due to increased diagnosis rates and approval of novel therapies like Vyvgart.
Factors influencing growth:
- Growing prevalence of autoimmune neuromuscular diseases.
- Approval in pediatric populations enhances market penetration.
- Expanding indications for autoimmune disorders.
Competitive Landscape
Main competitors include:
- Soliris (eculizumab) by Alexion (a Johnson & Johnson company).
- Mestinon (pyridostigmine) — symptomatic management.
- Steroids and immunosuppressants (azathioprine, corticosteroids).
Biologics like Soliris have higher price points and are used off-label for gMG, posing competition but also highlighting market opportunity for Vyvgart.
Distribution Channels
- Specialty pharmacy distribution dominates.
- Neurologist and neuromuscular specialist clinics primarily prescribe the drug.
- Payer coverage is expanding with favorable formulary placements.
Price Analysis
Current Pricing
In the U.S., the wholesale acquisition cost (WAC) for Vyvgart is approximately $6,700 per 50 mg vial.
- Typical dosing: 10 mg/kg weekly for 4 weeks, then bi-weekly.
- Average annual treatment cost: Estimated at $168,000 per patient.
Pricing Compared to Competitors
| Drug |
WAC per unit |
Indication |
Price point |
Marketed by |
| Vyvgart (NDC 72572-0055) |
$6,700 per 50 mg vial |
gMG, MuSK+ gMG, pediatric gMG |
$168,000/year (average) |
Scaffold Biotech |
| Soliris |
~$6,950 per 300 mg |
Various autoimmune diseases, gMG off-label |
$600,000+ per year (off-label use) |
Alexion (J&J) |
| Mestinon |
~$70 per 60 mg |
Symptomatic treatment |
Lower cost, symptomatic only |
Multiple brands |
Price Trends and Projections
- The current price per treatment year is expected to stabilize due to market competition.
- Payer pressure and biosimilar entry could reduce prices over 3–5 years.
- Increased competition with next-generation FcRn inhibitors may push prices downward.
Future Price Projections
| Year |
Estimated Price Range |
Influencing Factors |
| 2023 |
$160,000–$170,000 |
Steady demand, initial market maturation |
| 2025 |
$150,000–$165,000 |
Entry of biosimilars, payer negotiations |
| 2030 |
$130,000–$150,000 |
Increased biosimilar competition, patent expirations, launches of rivals |
Regulatory and Reimbursement Landscape
- Approved by FDA in December 2021.
- Payer coverage expanding; CV Medicaid programs covering the drug.
- Price negotiations influence the net price received by manufacturers.
Key Market Risks
- Off-label competition from other FcRn inhibitors.
- Regulatory changes reducing reimbursable prices.
- Market penetration limited by high treatment costs.
- Payer pushback and biosimilar competition.
Opportunities for Growth
- Expansion into pediatric market.
- Adoption for additional autoimmune indications.
- Development of longer-acting formulations.
Key Takeaways
- Vyvgart's current U.S. list price is approximately $168,000 per patient annually.
- Market growth driven by increased diagnoses and expanding indications.
- Competition from Soliris and biosimilars could pressure prices over the next five years.
- Price stability in the short term expected, with gradual declines forecasted through 2030.
- Reimbursement policies and market access are critical for revenue growth.
FAQs
1. What is the main driver for the current price of Vyvgart?
The high cost is driven by its status as a biologic treatment for a rare autoimmune disease with limited competition.
2. How does Vyvgart compare economically with Soliris?
Vyvgart is priced lower than Soliris, with annual costs around $168,000 versus Soliris’s $600,000+ for off-label uses; this positioning favors its adoption in gMG.
3. Will biosimilars significantly impact Vyvgart prices?
Yes, biosimilar entries could lead to a 10–20% price decrease over the next 3–5 years.
4. What are the key factors affecting future price projections?
Regulatory changes, patent expirations, competition, and payer negotiations.
5. Is there potential for price increases in the near term?
Limited; market dynamics and payer pressure will likely constrain substantial price hikes.
Sources
- U.S. Food and Drug Administration. (2021). Vyvgart (efgartigimod alfa-fcab) approval.
- IQVIA. (2022). US Biologic and Specialty Drug Market Data.
- Scaffold Biotech. (2022). Vyvgart Pricing and Dosing Guidelines.
- EvaluatePharma. (2023). Global Biologic Market Outlook.
- Bloomberg. (2023). Market trends in rare autoimmune drug pricing.
