Last updated: July 29, 2025
Introduction
The National Drug Code (NDC) 51407-0197 corresponds to a specific pharmaceutical product within the U.S. healthcare system. To provide a comprehensive market analysis and price projection, this report synthesizes current market dynamics, historical pricing trends, competitive landscape, and regulatory influences that shape the drug’s commercial trajectory. This analysis aims to inform pharmaceutical companies, healthcare providers, payers, and investors navigating the evolving landscape of this therapeutic agent.
Product Profile and Indications
NDC 51407-0197 identifies RimabotulinumtoxinB (Myobloc), a botulinum toxin type B administered for various neuromuscular conditions, including cervical dystonia, sialorrhea, and off-label uses like spasticity management. As a biologic, it operates via neuromuscular blockade, with efficacy well-documented in clinical studies. The product’s patent status, manufacturing exclusivity, and regulatory approvals significantly influence its market trajectory.
Market Landscape
1. Market Size and Growth Drivers
The botulinum toxin market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of approximately 8.5% through 2028, driven by:
- Expanding therapeutic indications: Beyond cosmetic uses, neurology, and dermatology, new off-label applications are emerging, broadening demand.
- Increasing prevalence of neuromuscular disorders: Rising aging populations contribute to the prevalence of conditions like cervical dystonia and spasticity.
- Technological advancements: Improved formulations and delivery methods enhance safety and efficacy, increasing adoption.
2. Competitive Environment
The primary competitor is Botulinum toxins from other brands such as Botox (onabotulinumtoxinA), Dysport (abobotulinumtoxinA), and Xeomin (incobotulinumtoxinA). Key competitive factors include:
- Pricing: Market leader Botox often commands premium pricing, with Myobloc positioned as a cost-effective alternative.
- Efficacy and safety profiles: While similar, subtle differences influence physician preference.
- Manufacturing and supply chain: Capacity impacts availability and cost, especially in market surges.
3. Regulatory Status
Myobloc received FDA approval in 2000 for cervical dystonia and subsequently for sialorrhea. Patent protections expired or are nearing expiration, increasing the vulnerability to biosimilar entries, which could disrupt existing pricing dynamics.
Historical Pricing Trends
Pricing for NDC 51407-0197 has witnessed fluctuations influenced by:
- Market penetration and physician adoption rates: Initial high prices gradually declined as competition increased.
- Payer negotiations: Reimbursement rates from Medicare, Medicaid, and private insurers exert downward pressure.
- Manufacturing costs: Economies of scale and biosimilar entries are expected to further compress prices.
Current average wholesale prices (AWP): Approximately $300 per unit, with treatment courses requiring variable units depending on the indication.
Price Projection Analysis
1. Short-term Outlook (1-2 years)
Given patent expirations and increasing biosimilar activity, expect a moderate price decline of 10-15%. The proliferation of biosimilars and intensified payer negotiations should further lower per-unit costs.
2. Mid to Long-term Outlook (3-5 years)
- Entry of biosimilars: Expected to reduce prices by up to 30-40% relative to current levels, similar to trends observed with other biologics.
- Regulatory incentives: Patent litigations and exclusivity periods will influence the timing of biosimilar market entry.
- Market consolidation and pricing strategies: Brand manufacturers may employ discounts, rebates, or value-based pricing to maintain market share.
3. Influencing Factors
- Reimbursement policies: Medicaid and Medicare Part B reimbursement structures influence net prices.
- Healthcare trends: Push towards value-based care may incentivize manufacturers to lower list prices.
- Global supply chain considerations: Any disruptions could temporarily influence prices.
4. Scenario Modeling
- Best Case (accelerated biosimilar entry): Prices could decrease by 40-50% within 3 years.
- Worst Case (delayed biosimilar entry or patent extensions): Prices may stabilize with minimal decline.
- Most probable scenario: A reduction of approximately 20-30% over five years, balancing biosimilar competition and market stabilization.
Implications for Stakeholders
- Manufacturers: Need to strategize around patent protections, biosimilar competitive entry, and value-based pricing models.
- Healthcare Providers: Should consider cost implications in treatment choices, especially as prices decline.
- Payers: Will benefit from competitive price pressures but should monitor biosimilar uptake for optimal reimbursement policies.
- Investors: Should anticipate margin compression, but also recognize opportunities tied to biosimilar development and market expansion.
Key Takeaways
- NDC 51407-0197 (Myobloc) operates within a dynamic, competitive botulinum toxin market poised for significant price adjustments due to biosimilar entry.
- Short-term price reductions are inevitable, primarily driven by biosimilar competition, with projected decreases of 10-15%.
- Long-term price declines could reach 30-50%, contingent on regulatory, patent, and market factors.
- Stakeholders must adapt strategies around patent expiry timelines, reimbursement policies, and emerging biosimilar offerings to optimize market positioning.
- Continuous monitoring of market signals, regulatory developments, and clinical adoption trends is essential for accurate forecasting.
FAQs
1. When is biosimilar competition expected for NDC 51407-0197?
Biosimilar candidates are in various stages of development, with regulatory filings anticipated within the next 1-3 years. Patent expirations, likely around 2025-2028, will open the market to biosimilar entries.
2. How will biosimilars impact the pricing of Myobloc?
Biosimilars are expected to drive prices downward by 30-50% over five years through increased competition, enhanced access, and payer preference for cost-effective options.
3. What factors influence the pricing trajectory of botulinum toxin drugs?
Key factors include patent status, regulatory approvals, manufacturing costs, payer negotiations, clinical efficacy, and market competition.
4. How do reimbursement policies affect the net price of NDC 51407-0197?
Reimbursement structures from Medicare and private insurers significantly influence net prices, with adjustments common based on negotiation, formulary inclusion, and value-based arrangements.
5. What strategies can manufacturers adopt to sustain profitability amidst declining prices?
Strategies include innovation in formulations, expanding therapeutic indications, securing exclusive licensing or patents, engaging in value-based contract models, and optimizing manufacturing efficiencies.
Sources
- MarketsandMarkets. (2022). Botulinum Toxin Market Analysis.
- U.S. Food and Drug Administration (FDA). Approved Drug Products.
- IQVIA. (2023). Biologics Market Reports.
- Centers for Medicare & Medicaid Services (CMS). Reimbursement Policies.
- EvaluatePharma. (2022). Biologic Pricing and Patents Outlook.
