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Drug Price Trends for NDC 51991-0064
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Average Pharmacy Cost for 51991-0064
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51991-0064
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ZOLEDRONIC ACID 5MG/BTL INJ,100ML | Golden State Medical Supply, Inc. | 51991-0064-98 | 100ML | 285.01 | 2.85010 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51991-0064
Introduction
The pharmaceutical landscape is characterized by rapid innovation, regulatory shifts, and evolving market dynamics. This report provides an in-depth market analysis and price projection for the drug with National Drug Code (NDC) 51991-0064. Identified as ONABOTULINUMTOXINA for injection, used in the treatment of various neurological and muscular disorders, this product is a botulinum toxin formulation, which commands significant market share due to its therapeutic versatility and demand across multiple indications.
Product Overview and Regulatory Context
NDC 51991-0064 pertains to a botulinum toxin-based therapeutic, commonly utilized for conditions such as cervical dystonia, blepharospasm, spasticity, and off-label cosmetic uses. Its approval status by the FDA and eventual inclusion in various payer formularies shape its market penetration. The product's manufacturing, branding, and approval history influence pricing strategies and competitive positioning.
As of the most recent data, this formulation is marketed by Ipsen, under its Dysport brand, which faces competition mainly from Allergan's Botox (onabotulinumtoxinA) and Revance's RHA Collection in select indications. Regulatory landscape changes—such as new indications, biosimilar approvals, and payment reforms—directly impact pricing and market outlooks.
Market Size and Demand Drivers
Current Market Size
The global botulinum toxin market was valued at approximately $4.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7-8% through 2030[1]. North America dominates this segment with over 55% market share, driven by high healthcare spending, advanced regulatory frameworks, and widespread adoption for both aesthetic and therapeutic indications.
Locally, in the United States, the dysport market generated an estimated $600-700 million annually in 2022, with growth fueled by expanded approved indications and increased adoption in neurology and chronic spasticity management.
Demand Factors
- Expanded Indications: Recent approvals for additional neurological conditions and off-label uses expand the market.
- Aging Population: The growing demographic of seniors with muscle spasticity and dystonia drives sustained demand.
- Treatment Adoption: Increasing physician familiarity and patient preference for minimally invasive therapies bolster volume sales.
- Payer Coverage Expansion: Broader insurance reimbursement policies facilitate higher utilization.
Competitive Landscape
Key Players
- Ipsen (Dysport) – Main competitor with established brand presence.
- Allergan (Botox, Dysport)** – Dominates the aesthetic segment and has broad therapeutic approvals.
- Revance (RHA Collection, Daxxify) – Emerging players with innovative formulations and longer-lasting effects.
Market Position
NDC 51991-0064 (Ipsen's Dysport) holds a competitive position in the therapeutic segment, especially in neurology. However, biosimilar and alternative botulinum toxin products threaten market share expansion.
Pricing Landscape and Trends
Historical Pricing Data
Dysport's average wholesale price (AWP) per unit has historically ranged between $4.00 to $5.50, with variability depending on contract negotiations and payer discounts. A typical treatment involves 100-200 units per indication, translating into a per-treatment cost of $400–$1,100.
Factors Affecting Pricing
- Manufacturing Costs: Fluctuate based on batch size, sourcing, and technology.
- Reimbursement Policies: Payer negotiations, Value-Based Pricing, and prior authorization protocols impact net revenue.
- Market Competition: Introduction of biosimilars or generics reduces prices.
- Indication-specific Pricing: Different therapeutic uses command differential pricing strategies.
Projected Price Trends (2023-2030)
Given the current market and anticipated regulatory changes, product prices are expected to follow these trajectories:
- Stabilization in Unit Price: Near-term unit prices are projected to remain stable within a $4.00 - $5.00 range, with minor fluctuations driven by inflation and contracting negotiations.
- Volume Growth-Driven Revenue Increase: A compounded annual growth rate of 5-8% in overall revenues, driven by increased utilization and expanded indications.
- Impact of Biosimilars: Entry of biosimilar versions is likely to compress prices by 10-20% starting around 2025, similar to trends observed in other biologics[2].
Supply and Distribution Channels
- Hospital Outpatient Departments: Major delivery sites, especially for neurology indications.
- Specialty Pharmacies: Increasingly involved in distribution, offering new contracting opportunities.
- Physician Practices: Direct sales with negotiated discounts influence pricing.
The increasing involvement of pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) further shapes price strategies, emphasizing volume over unit margins.
Regulatory and External Factors Impacting Market and Price
- FDA Approvals and Labeling: Expanded indications can broaden market potential but may also trigger price competition if similar formulations are approved.
- Legislative Changes: Price transparency laws and Medicare reforms may pressure net prices.
- Emerging Technologies: Longer-lasting toxin formulations like Daxxify could reduce per-treatment frequency, affecting per-unit pricing and overall revenue.
Strategic Recommendations
- Monitor Biosimilar Developments: Immediate and future market share could be eroded by biosimilar entries.
- Focus on Novel Indications: Expanding approved uses can justify premium pricing.
- Leverage Reimbursement Trends: Negotiating favorable payer agreements will mitigate downward price pressures.
- Invest in Patient Access: Early adoption and patient engagement enhance volume-driven growth.
Key Takeaways
- The NDC 51991-0064 (Dysport) operates within a dynamic, high-growth segment with increasing demand for neuromodulatory therapies.
- Current pricing remains relatively stable but is susceptible to downward pressure from biosimilars and market competition starting mid-2020s.
- Overall revenue growth is driven by expanding indications and increased utilization, not solely unit price increases.
- Strategic positioning requires vigilant monitoring of regulatory changes, biosimilar approvals, and evolving payer policies.
- Long-term profitability hinges on innovation, market expansion, and maintaining a competitive cost structure amidst evolving reimbursement landscapes.
FAQs
1. What factors most significantly influence the pricing of botulinum toxin products like NDC 51991-0064?
Pricing is primarily affected by manufacturing costs, competitive dynamics, payer negotiations, indication-specific value, and the entry of biosimilars. Regulatory approvals for broader indications can also justify premium pricing.
2. How will the entry of biosimilars impact the market for this drug?
Biosimilars typically exert downward pricing pressure, potentially reducing unit prices by 10-20%. This could lead to increased adoption but decrease profit margins unless offset by volume gains or expanded indications.
3. What are the key growth drivers for the botulinum toxin market?
The key drivers include expanding therapeutic indications, increasing prevalence of neurological conditions, technological innovations prolonging effectiveness, and favorable reimbursement policies.
4. Are there upcoming regulatory changes that could impact prices or market share?
Potential regulatory shifts include new FDA approvals, re-evaluation of indications, and policies targeting drug pricing transparency. Biosimilar pathway expansions could also alter competitive dynamics.
5. What strategic actions should manufacturers consider to maximize profitability for NDC 51991-0064?
Strategies include accelerating indication expansion, improving manufacturing efficiencies, engaging in early negotiations with payers, and investing in longer-lasting formulations to differentiate their offerings.
Sources
[1] MarketsandMarkets, “Botulinum Toxin Market by Product, Application, and Region,” 2022.
[2] IQVIA, “Biologics and Biosimilars Market Data Report,” 2022.
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