Last updated: February 19, 2026
What is NDC 17772-0133?
NDC 17772-0133 refers to a specific drug product approved by the FDA. Based on the National Drug Code (NDC) directory, this code corresponds to Eculizumab (Soliris), manufactured by Alexion Pharmaceuticals. Eculizumab is a monoclonal antibody targeting complement component C5, used primarily for rare complement-mediated disorders.
Current Market Position
Indications
Eculizumab is approved for multiple conditions:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Generalized myasthenia gravis (gMG)
- Neuromyelitis optica spectrum disorder (NMOSD)
Market Size and Demand Drivers
- The global market for Eculizumab was valued at approximately USD 3.6 billion in 2022.
- Growth is driven by increased diagnosis rates of rare complement disorders and expanding approved indications.
- The drug's life-cycle management includes new indications and geographic expansion.
Competitive Landscape
- Competitors include Ravulizumab (Ultomiris) from Alexion and other emerging therapies targeting complement pathways.
- Ravulizumab, with similar indications, has gained market share due to less frequent dosing.
Market Penetration
- In the U.S., Eculizumab is reimbursed predominantly through Medicare and private payers, with high treatment costs.
- Coverage is restricted but generally favorable for approved indications, leading to consistent demand.
Price Structure and Revenue
Current Pricing
- The wholesale acquisition cost (WAC) per 300 mg vial is approximately USD 6,500.
- Treatment regimens typically require 900-1,200 mg weekly initially, then every 2-4 weeks for maintenance.
- Annual treatment costs approximate USD 500,000 for eligible patients.
Revenue Breakdown (2022 Data)
| Parameter |
Estimate |
| Annual global sales |
USD 3.6 billion |
| U.S. share |
80% (USD 2.88 billion) |
| Average patient cost |
USD 500,000+ annually |
| Number of treated patients |
Estimated 7,000 in the U.S. |
Reimbursement and Billing
- Reimbursement rates are influenced by DRGs (Diagnosis-Related Groups) and Medicaid/Medicare policies.
- High drug price is partially offset by negotiated rebates with payers, though net revenue remains substantial.
Future Price Trends and Projections
Factors Influencing Price
- Patent exclusivity and regulatory exclusivity through 2029.
- Potential biosimilar entry anticipated post-2030.
- Cost-focused healthcare policies could pressure prices.
- Expansion into additional indications may stabilize or increase revenue.
Price Projection Scenarios (2023–2028)
| Scenario |
Drug Price per 300 mg vial |
Comments |
| Baseline (no change) |
USD 6,500 |
Maintains current pricing |
| Moderate decrease |
USD 5,500–6,000 |
Due to payer pressure, generic biosimilars |
| Significant price drop |
USD 4,500–5,000 |
Post-patent expiry, increased competition |
| Increase (rare) |
USD 7,000–8,000 |
For newly approved, orphan indications |
Market Entry of Biosimilars
- Biosimilar development has begun outside the U.S. and Europe.
- FDA approval for biosimilars targeting Eculizumab is expected by 2030.
- Biosimilar penetration could reduce U.S. prices by 30-50% over a 5-year period post-approval.
Regulatory and Policy Impact
- Recent biosimilar approval trends historically lead to 20-40% price reductions over 3-5 years.
- Payer negotiations and formulary placements increasingly favor biosimilars or lower-cost alternatives.
- Policy shifts toward value-based care could further influence pricing strategies.
Key Takeaways
- NDC 17772-0133 (Eculizumab) generated roughly USD 3.6 billion in global revenue in 2022.
- The U.S. accounts for approximately 80% of sales, with annual treatment costs exceeding USD 500,000 per patient.
- Current pricing remains stable around USD 6,500 per 300 mg vial, though pressure from biosimilars is expected starting post-2030.
- Future price adjustments depend on patent status, biosimilar integration, and healthcare policy changes.
- The market will likely see increased competition but continued demand driven by multiple approved indications.
FAQs
1. When will biosimilars for Eculizumab become available in the U.S.?
Biosimilars are expected to enter the U.S. market post-2030, following patent expiration and FDA approval processes.
2. How will biosimilar entry impact Eculizumab prices?
Prices could decrease by 30-50% within five years of biosimilar market entry, depending on market competition and payer negotiations.
3. What are key factors driving demand for Eculizumab?
Expansion of approved indications, higher diagnosis rates for complement diseases, and limited treatment alternatives.
4. Could new therapies replace Eculizumab?
Emerging treatments targeting different pathways could challenge Eculizumab, especially if they demonstrate better safety, efficacy, or cost profiles.
5. How do policy shifts influence pricing strategies?
Cost-containment policies and value-based payment models pressure drug prices and incentivize biosimilar adoption.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book).
[2] IQVIA. (2022). National Prescription Audit.
[3] Alexion Pharmaceuticals. (2022). Annual Report.
[4] EvaluatePharma. (2022). World Preview of Oncology and Rare Disease Treatments.
[5] Centers for Medicare & Medicaid Services. (2022). Payment Policies and Reimbursements.
