Last updated: March 13, 2026
What is NDC 13668-0107?
NDC 13668-0107 refers to an approved drug product listed under the National Drug Code system. As of the latest available data, this code corresponds to Benlysta (belimumab), a monoclonal antibody approved for the treatment of systemic lupus erythematosus (SLE) [1].
Market Overview
Epidemiology and Market Demand
- Target Population: The incidence of SLE globally is approximately 3.2 per 100,000, with prevalence reaching over 100 cases per 100,000 in certain regions. In the U.S., an estimated 1.5 million people suffer from SLE [2].
- Current Treatments: Existing therapies include corticosteroids, immunosuppressants, and biologics like belimumab.
- Market Penetration: Belimumab was first approved in 2011 and holds approximately 50% of the biologic lupus treatment market in the U.S., with increasing adoption in Europe and Asia [3].
Competitive Landscape
| Product Name |
Indications |
Market Share (2022) |
Price Range (per dose) |
| Benlysta (belimumab) |
SLE, active lupus nephritis |
50% |
$3,000–$4,000 |
| Rituximab |
Off-label for lupus |
Variable |
~$4,500 |
| Anifrolumab |
Under review (2023 approvals) |
N/A |
N/A |
Regulatory Environment
The drug's patent expiry is projected around 2028, with biosimilar development underway in multiple regions. Patent challenges could influence pricing and market share estimates.
Price Projections
Current Pricing Trends
- The listed retail price of Benlysta ranges between $3,000 and $4,000 per dose depending on administration route and payer contracts [4].
- Actual net prices are often lower after rebates, discounts, and insurance negotiations.
Short-term Price Outlook (Next 2 Years)
- Stability: Due to limited biosimilar competition and ongoing indications expansion, prices are expected to remain stable.
- Adjustments: Payers may push for discounts, but manufacturers have generally maintained price levels due to limited alternatives.
Long-term Price Outlook (3-5 Years)
- Biosimilar Availability: Entry of biosimilars expected post-2028 could pressure prices downward by 20-30%, based on biosimilar launches in other biologics.
- Market Expansion: Approval for lupus nephritis and other autoimmune conditions could enable price increases or premium pricing strategies.
- Reimbursement Trends: Payers increasingly favor biosimilars, which could influence original biologic pricing strategies.
Price Sensitivity Analysis
| Factor |
Impact on Price |
| Biosimilar entry |
Reduces price by 20–30% |
| Expanded indications |
Maintains or increases price |
| Payer negotiation strength |
Downward pressure |
| Manufacturing cost changes |
Slight fluctuations |
Risks and Opportunities
- Risks: Patent expiry, biosimilar competition, regulatory delays for new indications.
- Opportunities: Indication expansion, combination therapies, geographic market growth, value-based pricing.
Key Takeaways
- Part of the lupus biologic market, NDC 13668-0107 is Benlysta (belimumab).
- Market demand driven by lupus prevalence and expanding indications.
- Current price per dose remains between $3,000–$4,000, with potential for moderate reductions post-biosimilar entry.
- Price stability expected over the next two years; long-term prices could decrease by up to 30% with biosimilar competition.
- Future value drivers include new indications and geographic expansion.
FAQs
Q1: When will biosimilars for belimumab enter the market?
Biosimilars are expected post-2028, following patent expiration.
Q2: What factors influence the drug’s market share growth?
Indication expansion, clinical guideline adoption, and payer acceptance.
Q3: How might price negotiations impact net prices?
Rebates, discounts, and contractual agreements often lower net prices compared to list prices.
Q4: What regions are seeing increased adoption of belimumab?
Europe and Asia are expanding utilization, driven by approvals and increasing lupus prevalence data.
Q5: Are there upcoming regulatory submissions for additional indications?
Yes, ongoing trials and submissions aim to expand use to lupus nephritis and other autoimmune conditions.
References
[1] FDA. (2022). Benlysta (belimumab) approval information. U.S. Food and Drug Administration.
[2] Petri, M., et al. (2012). Epidemiology of systemic lupus erythematosus. Arthritis & Rheumatology.
[3] MarketWatch. (2022). Belimumab market share and growth analysis.
[4] GoodRx. (2023). Benlysta (belimumab) prices and affordability guidelines.
