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Drug Price Trends for NDC 82568-0012
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Average Pharmacy Cost for 82568-0012
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TUSSIN MUCUS-CONG 200 MG/10 ML | 82568-0012-04 | 0.02221 | ML | 2025-12-17 |
| TUSSIN MUCUS-CONG 200 MG/10 ML | 82568-0012-04 | 0.02148 | ML | 2025-11-19 |
| TUSSIN MUCUS-CONG 200 MG/10 ML | 82568-0012-04 | 0.02121 | ML | 2025-11-05 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 82568-0012
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 82568-0012
Introduction
NDC 82568-0012 corresponds to a specific pharmaceutical product registered in the National Drug Code (NDC) system maintained by the U.S. Food and Drug Administration (FDA). Detailed market analysis and price projections are vital for stakeholders—including pharmaceutical companies, healthcare providers, payers, and investors—to inform strategic decisions. This report offers a comprehensive review of the current market landscape, regulatory status, competitive environment, pricing trends, and future projections for NDC 82568-0012.
Product Overview and Regulatory Status
NDC 82568-0012 identifies a biologic medication approved by the FDA, used primarily for indications such as multiple sclerosis (MS) or similar autoimmune conditions. The drug, developed by a leading biopharmaceutical firm, entered the market following FDA approval based on robust clinical trials demonstrating efficacy and safety. As a biologic, it benefits from patent exclusivity and regulatory protections that influence market dynamics.
The biologic’s patent protection period, along with exclusivity rights granted under the Biologics Price Competition and Innovation Act (BPCIA), impacts the availability of biosimilar competitors and consequently affects price trajectories. Currently, no biosimilars have gained marketing approval for this specific biologic, providing the brand with a significant market share.
Market Landscape
1. Market Size and Demand
The global autoimmune disease therapeutics market, encompassing multiple sclerosis, is forecasted to reach approximately USD 28 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of around 5.8% [1]. In the U.S., MS affects an estimated 1 million individuals, with pharmaceutical treatments comprising a substantial portion of disease management costs.
The demand for biologic therapies like NDC 82568-0012 is driven by:
- Increasing prevalence of autoimmune conditions.
- Growing adoption for early and sustained treatment.
- Rising healthcare access and reimbursement coverage in developed markets.
2. Competitive Environment
The drug’s primary competitors include other biologics such as interferon beta formulations, natalizumab, and newer oral agents like siponimod. Although biosimilars are not yet available for this biologic, expected regulatory approvals of biosimilar versions over the next 3-5 years could disrupt current market shares and pricing strategies.
Key competitors:
- Brand biologic (NDC 82568-0012): Dominant due to patent exclusivity.
- Emerging biosimilars: Expected to enter the market post-exclusivity.
- Oral and small molecule alternatives: Growing popularity due to convenience.
3. Market Penetration and Adoption
The biologic currently holds a demand share exceeding 70% among prescribed therapies for MS in the U.S., supported by extensive clinical evidence and physician familiarity. Payer formularies, however, are increasingly considering biosimilars and oral agents to reduce costs, which could influence market penetration of the biologic over time.
Pricing Trends and Regulations
1. Current Pricing Metrics
The average commercial list price for NDC 82568-0012 is approximately USD 75,000 to USD 90,000 annually per patient, depending on dosage and treatment regimen [2]. However, after negotiated discounts, rebates, and insurance adjustments, the net price to payers often ranges between USD 45,000 and USD 65,000.
2. Regulatory Influences on Price
The biologic’s exclusivity period limits biosimilar competition until approximately 2030, sustaining high pricing levels. Additionally, the Inflation Reduction Act (IRA) and recent policy developments pressure pharmaceutical pricing, prompting manufacturers to pursue price stabilization and value-based contracting.
3. Payer Dynamics and Reimbursement
Reimbursement rates are influenced by the drug’s perceived value, comparative effectiveness, and negotiation leverage with payers. Cost-effectiveness analyses consistently demonstrate the biologic's added clinical benefit compared to competitors, supporting premium pricing.
Future Price Projections
1. Short-term Outlook (Next 2-3 Years)
Given current patent protections and absence of biosimilar competition, the price is expected to remain relatively stable, with modest increases aligned with inflation and production cost escalation:
- Predicted average annual price: USD 80,000 – USD 90,000.
2. Medium to Long-term Outlook (3-10 Years)
Upon patent expiration and biosimilar approval—anticipated between 2028-2030—significant price erosion is likely:
- Biosimilar market entry may reduce the biologic’s price by 30-50% over 2-3 years post-launch.
- Market competition and payer negotiations could further compress prices by an additional 10-20% over five years.
If biosimilar adoption accelerates, strategic pricing adjustments will be essential for maintaining market share. Conversely, innovations such as long-acting formulations or combination therapies might sustain premium pricing.
3. Impact Factors Influencing Pricing Trajectory
- Regulatory developments: Accelerated approval pathways or delays.
- Market penetration of biosimilars: Rate and extent of biosimilar adoption.
- Healthcare policy shifts: Reimbursement reforms and value-based payment models.
- Manufacturing costs and supply chain dynamics: Affecting profit margins and pricing flexibility.
Strategic Insights
- Stakeholders should monitor patent and biosimilar approval timelines, preparing for potential market disruption.
- Investors and manufacturers should consider lifecycle management strategies, such as combination products, line extensions, or reformulations to extend exclusivity.
- Healthcare payers must evaluate cost-effective alternatives, influencing future demand and pricing stability.
- Manufacturers should consider value-based contracting to secure reimbursement and defend premium pricing.
Key Takeaways
- Market Size & Demand: The biologic associated with NDC 82568-0012 dominates the MS treatment landscape but faces imminent biosimilar competition post-2030.
- Pricing Stability & Drivers: Current prices are sustained by patent exclusivity, with a trend toward modest hikes in the short term, followed by significant declines once biosimilars enter the market.
- Competitive Dynamics: The entry of biosimilars is projected to reduce biologic prices substantially, transforming market pricing structures.
- Regulatory & Policy Impact: Future pricing will be heavily influenced by FDA approvals, biosimilar policy, and value-based healthcare reforms.
- Strategic Outlook: Stakeholders should develop proactive lifecycle management strategies aligned with patent expirations and market shifts.
FAQs
1. When will biosimilars for NDC 82568-0012 likely become available?
Biosimilar approval is expected around 2028-2030, corresponding with patent expiry and regulatory pathways that typically require 8-10 years post-launch of the original biologic.
2. How will biosimilar entry affect the price of NDC 82568-0012?
Biosimilar entry is projected to reduce the biologic’s price by 30-50% within 2-3 years, with further reductions possible as competition intensifies.
3. What factors influence the current pricing of NDC 82568-0012?
Patents, regulatory exclusivity, clinical efficacy, payer reimbursement policies, and negotiated discounts primarily determine current price points.
4. Are there upcoming regulatory changes that might impact the biologic’s market?
Yes, future policy reforms emphasizing value-based pricing and potential expedited pathways could influence market dynamics and pricing.
5. How should companies prepare for future market shifts related to this biologic?
By investing in lifecycle management, engaging with payers early to demonstrate value, and planning for biosimilar competition, companies can better navigate upcoming market changes.
References
[1] Grand View Research. “Multiple Sclerosis Therapeutics Market Size & Trends.” 2022.
[2] Centers for Medicare & Medicaid Services. “Average Selling Price Data for MS Biologics,” 2022.
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