Last updated: August 17, 2025
Introduction
ND C 60846-0810 refers to a specific pharmaceutical product registered with the National Drug Code (NDC) system managed by the U.S. Food and Drug Administration (FDA). While the NDC system ensures precise identification of medications, detailed data on a given code—such as the active ingredient, formulation, manufacturer, and indications—is publicly accessible through various healthcare databases and regulatory filings. For this analysis, we focus on a comprehensive market overview and future price trajectory of the drug associated with NDC 60846-0810, providing insights critical for stakeholders, including healthcare providers, payers, and pharmaceutical companies.
Product Overview and Therapeutic Indication
Based on available industry data and the NDC registry, NDC 60846-0810 corresponds to Xultophy 100/3.6 (insulin degludec and liraglutide injection), manufactured by Novo Nordisk. This combination therapy is developed for managing type 2 diabetes mellitus, offering a dual mechanism—insulin degludec provides basal insulin coverage, while liraglutide acts as a glucagon-like peptide-1 receptor agonist, enhancing glycemic control.
Given the critical role of this combination therapy, demand is driven primarily by the prevalence of type 2 diabetes, which affects approximately 37 million Americans, with a significant proportion on insulin therapy (CDC, 2021).
Market Landscape
Competitive Environment
The market for injectable medications for type 2 diabetes is highly competitive, with key players including Novo Nordisk, Eli Lilly, and Sanofi. The primary competitors to Xultophy include:
- Insulin analogs alone such as Tresiba (insulin degludec) and Lantus (insulin glargine).
- GLP-1 receptor agonists including Trulicity (dulaglutide) and Ozempic (semaglutide).
- Fixed-dose combinations such as Soliqua 100/33 (insulin glargine/lixisenatide).
Xultophy’s unique value proposition lies in its combined mechanism, potentially reducing the injection burden and improving glycemic management.
Market Penetration and Adoption
Despite its clinical benefits, Xultophy’s market penetration remains moderate — attributed to factors such as prescribing physician preferences, insurance formularies, and cost considerations. Its relatively high acquisition costs have limited widespread adoption, particularly among cost-sensitive payers and patients.
Regulatory and Reimbursement Dynamics
Insurance coverage is a key determinant influencing sales. Managed Medicaid and Medicare Part D plans have increasingly implemented formulary restrictions favoring lower-cost alternatives or preferred combination therapies. Recent approval of biosimilars and generics in the diabetes space could further pressure prices.
Pricing Trends and Cost Analysis
Historical Price Data
The wholesale acquisition cost (WAC) of Xultophy has experienced gradual changes:
- 2018: Approximately $500 per pen (30-day supply) [2].
- 2020: Slight increase to around $520.
- 2022: Prices hovered around $530–$550, reflecting inflation and manufacturing costs.
The price variance highlights a controlled pricing strategy, possibly influenced by payer negotiations and market competition.
Current Price Projections
Given the current trends and market dynamics, the following projections are proposed:
- 2023–2025: A moderate annual increase of 2-3% is expected, driven primarily by inflation and slight improvements in manufacturing efficiency.
- Post-2025: Prices may stabilize or slightly decrease due to rising biosimilar entries and cost containment measures.
By 2025, the estimated WAC could approximate $570–$600 per pen, assuming sustained demand and no significant regulatory or market disruptions.
Factors Influencing Future Price Trends
- Biosimilar Competition: The entry of biosimilar insulin products and GLP-1 receptor agonists could decrease prices through increased market competition.
- Healthcare Policy Changes: Implementation of value-based pricing models and increased emphasis on biosimilars may pressure manufacturers to further reduce prices.
- Drug Efficacy and Compliance: Demonstrated improvements in patient outcomes could justify premium pricing or enable manufacturers to maintain current price levels.
- Manufacturing and Supply Chain Dynamics: Advances in biomanufacturing efficiency and raw material costs can influence pricing trajectories.
- Patient Assistance Programs: Implementation of manufacturer or insurance programs aimed at reducing out-of-pocket expenses may alter the effective consumer price.
Market Opportunities and Risks
Opportunities
- Growing market for combination therapies, particularly among patients inadequately controlled on monotherapy.
- Innovative delivery devices that improve patient adherence could command premium pricing.
- Expanding indications, such as use in obesity management, could diversify revenue streams.
Risks
- Pricing pressures from biosimilars may necessitate aggressive price reductions.
- Regulatory hurdles may delay or restrict new market entrants or formulations.
- Cost-containment policies and formulary restrictions could limit revenue potential.
Conclusion
The market for NDC 60846-0810 (Xultophy) remains stable but increasingly competitive. While current pricing maintains a premium position due to clinical benefits, future market forces—especially biosimilar proliferation and policy reforms—are likely to exert downward pressure on prices. Stakeholders should monitor regulatory developments, competitive landscape shifts, and payer strategies to anticipate pricing trends and optimize market positioning.
Key Takeaways
- The product, Xultophy, targets a growing diabetes segment, with demand tied directly to prevalence rates.
- Current pricing (~$550 per pen) is relatively stable but faces potential decline with biosimilar competition.
- Market adoption remains moderate, constrained by cost and formulary restrictions.
- Future projections suggest modest price inflation (2-3% annually) through 2025, followed by potential stabilization or reduction.
- Strategic opportunities include leveraging innovations and expanding indications, whereas risks encompass biosimilar entry and policy pressures.
FAQs
1. What factors most influence the pricing of NDC 60846-0810?
Pricing is primarily affected by manufacturing costs, patent status, market competition (biosimilars), payer negotiations, and regulatory policies impacting drug reimbursement.
2. How does biosimilar competition impact the price projections?
Biosimilars typically drive prices downward due to increased market competition, which can lead to a 20-40% reduction over several years, depending on adoption rates and regulatory acceptance.
3. What clinical advantages does Xultophy offer over monotherapies?
Xultophy combines basal insulin with a GLP-1 receptor agonist, improving glycemic control, reducing injection burden, and potentially lowering hypoglycemia risk compared to insulin alone.
4. How are payer policies expected to shape future market dynamics?
Payers are increasingly favoring cost-effective therapies, using formularies and tiering to incentivize the use of lower-cost alternatives, likely reducing the market share and pricing of branded combination therapies.
5. What strategic moves can pharmaceutical companies make to sustain profitability?
Innovating delivery systems, expanding indications, improving patient adherence, and engaging in value-based pricing negotiations are key strategies to maintain competitiveness and profitability.
Sources
[1] CDC. "National Diabetes Statistics Report," 2021.
[2] GoodRx. "Price history of Xultophy," 2022.
