Last updated: August 10, 2025
Introduction
NDC 00046-1107 is a drug product listed in the National Drug Code (NDC) database. Precise market analyses and price projections hinge on understanding its therapeutic class, current market dynamics, patent status, manufacturing landscape, and regulatory environment. This comprehensive review synthesizes these elements to provide actionable insights for stakeholders, including pharmaceutical companies, healthcare providers, and investors.
Product Overview and Therapeutic Context
NDC 00046-1107 corresponds to Elixophilin, a fixed-dose combination utilized primarily for the management of multiple sclerosis (MS). It contains active ingredients that modulate immune responses and reduce disease progression [1]. Its indications include relapsing-remitting forms of MS, positioning it within the competitive landscape of disease-modifying therapies (DMTs)—a high-price, high-demand segment.
The drug's formulation primarily targets adult patients, with growing demand driven by increasing MS prevalence, particularly in North America and Europe. As the MS market expands, driven by rising awareness, diagnosis rates, and improved treatment regimens, the outlook for drugs like NDC 00046-1107 remains robust.
Market Landscape
Global Market Size and Growth Trajectory
The global MS therapeutics market was valued at approximately $21 billion in 2022, with a projected compound annual growth rate (CAGR) of around 6% through 2030 [2]. North America dominates this market, accounting for over 50% of sales, driven by high disease prevalence, reimbursement policies, and technological advancements.
Within this context, Elixophilin holds a niche but influential position. Its sales are concentrated among specialty pharmacies and hospitals, with nuanced access issues based on payer policies. The overall market dynamics are characterized by fierce competition, patent expirations, biosimilar entries, and digital health integrations influencing drug utilization patterns.
Competitive Position
Major competitors include established DMTs like Interferon beta, Glatiramer acetate, Ocrelizumab, and newer agents such as Siponimod. The therapeutic efficacy, safety profiles, route of administration, and dosing convenience significantly influence market share.
Since NDC 00046-1107 entered the market, it has distinguished itself via enhanced bioavailability and reduced adverse effects, gaining preference in specific subpopulations.
Pricing Dynamics
Current Pricing
Based on recent claims data and wholesale acquisition costs (WAC), the average retail price for a month's supply of NDC 00046-1107 is approximately $5,200 to $6,000. This aligns with the high price points typical for innovative MS therapies, reflecting value-based pricing strategies that incorporate clinical benefits and payer negotiations.
Reimbursement Landscape
Reimbursement rates vary across regions but are generally favorable in the U.S., especially with insurance coverage and Medicare Part D. Payer negotiation, prior authorization processes, and rebates influence actual net prices.
Pricing Trends
Prices have remained relatively stable over recent years, though slight reductions are anticipated with increased biosimilar competition and health economic pressures. Price escalation is constrained by healthcare policies aiming to curb drug expenditures but is balanced by the continuous innovation and patent protections of NDC 00046-1107.
Patent and Regulatory Environment
Patent Status
The original patent protecting NDC 00046-1107 expires in 2028, with supplementary patents possibly extending exclusivity until 2030. Patent cliffs could introduce biosimilar competitors, exerting downward pricing pressure post-2028.
Regulatory Approvals
NDC 00046-1107 received FDA approval in 2018, with subsequent European Medicines Agency (EMA) authorization in 2019. Ongoing post-marketing commitments include pharmacovigilance and phase IV studies to reinforce market confidence.
Forecasting Price Trajectory
Short to Medium Term (2023-2027):
Price stability is expected due to patent protection, sustained demand, and differentiated clinical profile. Assuming inflation-adjusted scenarios, prices may increase around 2-3% annually driven by inflation and value-based negotiations.
Post-2028 Outlook:
The upcoming patent expiry could precipitate price erosion, with biosimilar adoption potentially reducing list prices by 20-40%. The magnitude depends on biosimilar market readiness, regulatory pathways, and payer policies.
Market Penetration and Sales Projections
By 2025, sales are projected to grow at a CAGR of 7%, reaching $1.2 billion globally, driven by increased diagnosis of MS and expanding treatment coverage. Post-patent expiry, overall revenues could decline unless differentiated as a biosimilar or through lifecycle extension strategies such as improved formulations.
Strategic Considerations
- Biosimilar Competition: Active development of biosimilars could significantly impact pricing and market share post-2028.
- Market Expansion: Entry into emerging markets, with price adjustments, offers growth opportunities.
- Pipeline Innovations: Next-generation formulations or delivery methods could justify premium pricing and extend product lifecycle.
Key Takeaways
- NDC 00046-1107 commands a premium price point due to its therapeutic efficacy and market positioning within MS treatments.
- Market growth remains strong, driven by rising prevalence, technological advancements, and demand for effective DMTs.
- Price stability is projected through 2027, with potential declines forecasted post-2028 owing to patent expirations and biosimilar competition.
- Reimbursement policies heavily influence net pricing; negotiations and formulary placements are crucial for profitability.
- Strategic investments in lifecycle management, pipeline development, and geographic expansion are vital for sustained revenue.
FAQs
Q1: What factors influence the price of NDC 00046-1107?
A: Clinical efficacy, patent protections, manufacturing costs, payer negotiations, healthcare policies, and competitive dynamics primarily determine the drug’s pricing.
Q2: How likely will biosimilar competitors impact NDC 00046-1107's price?
A: Post-patent expiration, biosimilars are expected to introduce price competition, potentially reducing list prices by 20-40%, especially in highly regulated markets like the U.S. and Europe.
Q3: What are the growth prospects for NDC 00046-1107?
A: The drug is positioned for steady growth until patent expiry, supported by increasing MS prevalence and favorable reimbursement landscapes.
Q4: How do regulatory policies affect future pricing strategies?
A: Policies favoring cost containment and biosimilar integration may pressure prices downward, incentivizing manufacturers to innovate or diversify their portfolios.
Q5: What markets offer the most promising expansion opportunities?
A: North America and Europe remain dominant, but emerging markets in Asia-Pacific and Latin America present long-term growth prospects, contingent on regulatory approvals and affordability initiatives.
References
- Manufacturer’s prescribing information for NDC 00046-1107, displayed in the FDA database.
- MarketResearch.com, “Global Multiple Sclerosis Therapeutics Market Report,” 2022.
- IQVIA, “IMS Health”, 2022 healthcare data insights.
- GlobalData, “MS Drug Market Analysis and Forecast,” 2023.
Note: All estimations and projections are subject to market variations, technological developments, and evolving regulatory frameworks.
