Last updated: February 22, 2026
What is NDC 31722-0298?
NDC 31722-0298 is the National Drug Code associated with Tavneos (avacopan), a prescription medication for the treatment of adult patients with severe eosinophilic granulomatosis with polyangiitis (EGPA). Approved by the FDA in May 2021, Tavneos is marketed by ChemoCentryx. Its mechanism involves selective inhibition of complement component 5a (C5a), which modulates inflammatory responses associated with EGPA.
Market Size and Demand Dynamics
Indication and Prevalence
EGPA is a rare vasculitis affecting approximately 2.7 to 4 per million individuals globally, translating into a limited patient base. In the U.S., estimates suggest about 300-400 patients per year are diagnosed.
R&D Investment and Competitive Landscape
- Market exclusivity: Tavneos holds patent protection through at least 2030 in the U.S.
- Competing drugs: Mepolizumab (Nucala) also approved for EGPA; it has an estimated annual sales exceeding $500 million globally.
- Reimbursement: Managed by payers considering the disease severity and existing treatment options.
Estimated Market Penetration
Initial adoption rates are expected to be modest, with a gradual increase as awareness improves and physicians prefer targeted therapies over traditional immunosuppressants. By 2030, projections estimate:
| Year |
Patient Adoption (U.S.) |
Annual Revenue (USD millions) |
| 2023 |
50-150 patients |
50-75 |
| 2025 |
200-400 patients |
200-400 |
| 2030 |
600-800 patients |
600-1,000 |
Global trends could increase these figures, particularly with broadened approval for other vasculitis indications.
Pricing Analysis
Current List Price
- Average wholesale price (AWP): Estimated at $8,800 per month per patient, based on comparable biologics.
- Annual Cost: Approximately $105,600 per patient**.
Pricing Strategy
- The high list price aligns with orphan drug norms, reflecting R&D costs recovery and specialty market positioning.
- Managed care negotiations often lead to significant discounts, typically between 25-40%.
Price Trends and Influencing Factors
- Market access: Payor restrictions may limit reimbursement, pressuring net prices.
- Competitive pricing: Mepolizumab costs about $35,000 per year, influencing pricing benchmarks.
- Regulatory pathways: Potential for orphan drug designation renewal or extended exclusivity could stabilize pricing.
Price Projections (Next 5 Years)
| Year |
Estimated Average Wholesale Price |
Notes |
| 2023 |
$8,800/month |
Launch year, initial list price |
| 2024 |
$8,600/month |
Slight discounts to secure formulary inclusion |
| 2025 |
$8,400/month |
Market stabilization, increased competition |
| 2026 |
$8,200/month |
Cost of goods (COGS) reduction impact |
| 2027 |
$8,000/month |
Likely maintained with minor adjustments |
Market Risks and Opportunities
Risks
- Low patient population limits overall revenue potential.
- Competitive pressure from existing biologics.
- Payer resistance to high-cost orphan drugs.
- Off-label use restrictions impacting demand.
Opportunities
- Expanded label indications for broader vasculitis conditions.
- Use in other autoimmune or inflammatory conditions with complement involvement.
- Partnership with patient advocacy groups to increase awareness.
Regulatory and Reimbursement Outlook
- Potential for biosimilar entry by 2030 could reduce prices.
- Continued dialogue with CMS, Medicaid, and private payers will influence reimbursement levels.
- Orphan drug designation provides some market exclusivity and advanced pricing leverage.
Key Takeaways
- NDC 31722-0298 (Tavneos) targets a niche and growing segment within vasculitis treatment.
- Market is modest due to the rare disease prevalence but offers sustained exclusivity-driven revenue.
- List prices are high, but actual net prices tend significantly lower after discounts and negotiations.
- Revenue projections indicate limited but steady growth, constrained by patient numbers and competition.
- Price sustainability depends heavily on market access strategies and potential indication expansions.
FAQs
1. How does Tavneos's pricing compare to similar treatments?
It is priced higher than drugs like mepolizumab ($35,000/year) but reflects increased specificity and brand positioning.
2. What factors could impact Tavneos's future market share?
Competitive drugs, payer restrictions, and new approvals for broader vasculitis indications.
3. Are there plans for label expansion?
Potential exists for use in other complement-mediated diseases, which could expand the market.
4. How do discounts and rebates affect net revenue?
Negotiated discounts typically reduce gross prices by 25-40%, impacting actual sales revenue.
5. When might biosimilars or generics enter the market?
Likely around 2030 post-exclusivity, which could pressure prices and reduce profitability.
References
- U.S. Food and Drug Administration. (2021). Tavneos approval announcement.
- IQVIA. (2022). Global sales data for biologic therapies.
- ChemoCentryx. (2022). Tavneos product information and development pipeline.
- MarketWatch. (2023). Rare disease drug market analysis.
- SSR Health. (2022). Biologic pricing and reimbursement trends.
