Last updated: February 24, 2026
What Is NDC 00173-0777?
NDC 00173-0777 refers to a specific pharmaceutical product marketed by a manufacturer under the National Drug Code (NDC) system. The NDC 00173-0777 corresponds to Benlysta (belimumab), a monoclonal antibody used in the treatment of systemic lupus erythematosus (SLE).
Market Overview
Current Market Size
The global systemic lupus erythematosus market reached approximately USD 1.93 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030[1]. Benlysta holds a significant share within this market, driven by its first-in-class status for SLE treatment approved by the FDA in 2011.
Key Competitors
- Anifrolumab (Saphnelo): Approved for SLE in 2021; expanding treatment options.
- Methotrexate, corticosteroids: Conventional therapies, less costly but with limited efficacy comparison.
- Other biologics under development: Belimumab biosimilars are entering late-stage development, potentially impacting pricing and market share.
Usage & Patient Demographics
Estimated annual U.S. prescriptions for Benlysta totaled approximately 25,000 units in 2022, with per-unit sales averaging USD 3,200[2]. Patients are typically middle-aged women with moderate to severe SLE, with treatment persistence influenced by efficacy and safety profile.
Regional Market Dynamics
- U.S. market dominates with 70% of sales.
- Europe accounts for 20%, with increasing adoption due to expanded indications.
- Rest of World (ROW): Growing markets in Asia-Pacific and Latin America, constrained by reimbursement and approval timelines.
Pricing Trends and Projections
Current Pricing
A standard dose of Benlysta (200 mg IV infusion) costs about USD 4,200 per infusion in the U.S., with a typical treatment cycle of 6 infusions per month, translating to USD 25,200/month[3].
- Total annual cost per patient: approximately USD 302,400.
Biosimilars, once approved, could reduce prices by 30-50%, depending on market entry timing and competition.
Market Drivers for Price Changes
- Patent expiration: Benlysta's patents are set to expire in 2028, opening pathways for biosimilar competition.
- Regulatory approvals: Broader indications and international approvals can sustain or increase prices.
- Manufacturing costs: Advances in bioprocessing may lower production costs, potentially leading to price reductions.
- Reimbursement policies: Payers' cost containment efforts could pressure list prices downward, especially with biosimilar entry.
Price Projection (2023-2030)
| Year |
Estimated Average Price per Infusion (USD) |
Notes |
| 2023 |
USD 4,200 |
Current price, with minimal variation |
| 2025 |
USD 3,900 - USD 4,100 |
Pre-patent expiration, biosimilar development underway |
| 2027 |
USD 3,700 - USD 4,000 |
Approaching patent expiry, biosimilar launches expected |
| 2028 |
USD 3,000 - USD 3,500 |
Post-patent, biosimilar market enters |
| 2030 |
USD 2,800 - USD 3,200 |
Biosimilars gain significant market share |
Strategic Implications for Stakeholders
- Pharmaceutical companies: Significant upside hinges on biosimilar approval and market penetration post-2028.
- Payers: Cost control measures will influence formulary placement and reimbursement levels.
- Patients: Market entry of biosimilars may improve access through lower prices.
Key Market Risks
- Delayed biosimilar approvals or market entry.
- Regulatory hurdles in international markets.
- Competitive innovations reducing demand for Belimumab.
Key Takeaways
- The SLE biologic market is growing steadily, with Benlysta leading in market share.
- Major price reductions are expected post-2028, aligned with biosimilar entry.
- Current U.S. prices approximate USD 4,200 per infusion, with potential reductions of 30-50% over the next five years.
- Market expansion into Europe and ROW presents upside but faces regulatory and reimbursement challenges.
- Patent cliffs and biosimilar development will drive significant price and market share shifts.
FAQs
Q1: When will biosimilars for Benlysta become available?
A1: Biosimilar development is ongoing; approvals are expected post-2028, following patent expiry.
Q2: How will biosimilars impact current pricing?
A2: Biosimilars could reduce prices by 30-50%, depending on competition and market dynamics.
Q3: What factors influence the adoption of Benlysta in new markets?
A3: Regulatory approvals, reimbursement policies, and physician familiarity.
Q4: Are there upcoming indications that could expand Benlysta’s market?
A4: Yes, ongoing research aims to evaluate efficacy in other autoimmune conditions, potentially broadening its use.
Q5: How does Benlysta compare to newer therapies in efficacy?
A5: Clinical trials demonstrate comparable or superior efficacy to traditional therapies, with a favorable safety profile[4].
References
[1] MarketsandMarkets. (2022). Systemic Lupus Erythematosus Market by Product, Region - Global Forecast to 2030.
[2] IQVIA. (2022). Physician and Pharmacy Data Reports.
[3] GoodRx. (2023). Cost of Benlysta.
[4] Furie, R., et al. (2011). "A phase 3 trial of belimumab in patients with active systemic lupus erythematosus." New England Journal of Medicine, 365(21), 2119–2128.
