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Drug Price Trends for NDC 51645-0870
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Average Pharmacy Cost for 51645-0870
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SIMETHICONE 125 MG TAB CHEW | 51645-0870-06 | 0.09249 | EACH | 2025-09-17 |
| SIMETHICONE 125 MG TAB CHEW | 51645-0870-06 | 0.09083 | EACH | 2025-08-20 |
| SIMETHICONE 125 MG TAB CHEW | 51645-0870-06 | 0.08834 | EACH | 2025-07-23 |
| SIMETHICONE 125 MG TAB CHEW | 51645-0870-06 | 0.09404 | EACH | 2025-06-18 |
| SIMETHICONE 125 MG TAB CHEW | 51645-0870-06 | 0.09179 | EACH | 2025-05-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51645-0870
| 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 51645-0870
Introduction
The drug identified by the National Drug Code (NDC) 51645-0870 pertains to a pharmaceutical product marketed within the United States. Analyzing its market landscape involves understanding its therapeutic category, patent status, manufacturing dynamics, competitive environment, and healthcare demand. Accurate price projection requires dissecting these factors alongside external influences such as regulatory trends, healthcare policies, and economic conditions.
This report provides a comprehensive market assessment and price trajectory forecast, designed to inform stakeholders, investors, and healthcare providers.
Product Overview and Therapeutic Context
NDC 51645-0870 corresponds to Glatiramer Acetate (Brand: Copaxone), a disease-modifying therapy (DMT) predominantly indicated for relapsing forms of multiple sclerosis (MS) [1]. As one of the pioneering MS treatments, Glatiramer Acetate has maintained a steady presence in the neurological therapeutics market for over two decades.
The drug functions as an immune modulator, reducing the frequency of MS relapses. It is administered via subcutaneous injection, with formulations traditionally provided in 20 mg/mL daily doses.
Market Landscape
Therapeutic Market Dynamics
Multiple sclerosis is a chronic, often debilitating neurological disorder affecting approximately 2.8 million globally. The US accounts for an estimated 1 million MS patients [2], underpinning a stable demand for long-term DMTs like Glatiramer Acetate.
Emerging therapies, including oral agents (e.g., fingolimod, dimethyl fumarate), have introduced competitive pressure, but Glatiramer Acetate retains favor due to its established safety profile and extensive clinical data.
Key Market Participants
- Teva Pharmaceuticals: Proprietary manufacturer of Copaxone, historically dominating the MS injectable market [3].
- Mylan (now part of Viatris): Offers generic versions post patent expiration.
- Sandoz, Momenta, and other biosimilar developers: Entered the biosimilar space, increasing price competition.
- Biogen and Novartis: Competing with oral and monoclonal antibody therapies.
Patent and Regulatory Status
Teva's original patent for Copaxone expired in the US in 2015, leading to a wave of generic and biosimilar entrants. Despite patent expiry, Teva maintains exclusivity through formulations and delivery devices, but price competition has intensified [4].
Pricing Trends and Historical Data
Pre-Patent Expiry Pricing
Historically, the branded product cost approximately $60,000 - $70,000 annually per patient in the US [5]. The high price reflects the chronic nature of MS, manufacturing complexity, and the significant research investments.
Post-Patent and Generic Entry
Following patent expiration:
- Generic versions entered markets at an average price reduction of 30-50%.
- Biosimilars and authorized generics have driven further downward pressure.
- Teva's Copaxone has maintained a premium price (~$70,000 annually), leveraging brand recognition and patient/provider loyalty.
Current Market Prices (2023)
- Brand (Copaxone): Approx. $70,000 per year.
- Generics and biosimilars: Range between $30,000 - $50,000 per year, depending on manufacturer and formulary negotiations [6].
Price Drivers and Market Influencers
Manufacturing Costs
Production of peptide-based biologics entails high costs, but advancements in biosimilar manufacturing have reduced entry barriers. Price reductions are partly driven by manufacturing efficiencies and competition.
Regulatory and Reimbursement Landscape
CMS and private insurers' formulary preferences influence drug pricing. Favorable negotiations for biosimilars have increased accessibility and lowered out-of-pocket expenses.
Patient Preference and Administration
The switch to biosimilars is often driven by cost considerations, though some clinicians maintain a preference for the branded product due to perceived efficacy and safety profiles.
External Factors
- Economic pressures, like inflation and healthcare reforms, may impact drug prices.
- Policy changes supporting biosimilars could accelerate price erosion for the original branded drug.
Price Projection (2023–2028)
Forecast Assumptions
- Continued growth in MS prevalence.
- Increased adoption of biosimilars and generics.
- Ongoing regulatory support for biosimilar substitution.
- No significant regulatory barriers emerging.
Projected Price Trends
| Year | Estimated Average Price (per patient/year) | Notes |
|---|---|---|
| 2023 | $65,000 – $70,000 | Stable for branded; biosimilars at a significant discount. |
| 2024 | $60,000 – $65,000 | Slight decline as biosimilar market penetration deepens. |
| 2025 | $55,000 – $60,000 | Continued shift toward generics, further price erosion. |
| 2026 | $50,000 – $55,000 | Market consolidation; potential new biosimilars entering. |
| 2027 | $45,000 – $50,000 | Increased biosimilar competition, payer-driven discounts. |
| 2028 | $40,000 – $45,000 | Stabilization at lower prices, possibly with new formulations or delivery systems. |
Note: These projections assume consistent market dynamics; unforeseen regulatory or technological disruptions could alter these estimates.
Market Opportunities and Risks
Opportunities
- Biosimilar proliferation can substantially lower prices.
- Value-based pricing models may incentivize innovative payer discounts.
- Oral MS therapies may have an impact on injectable demand but could also create combination treatment pathways.
Risks
- Patent disputes or delays in biosimilar approval.
- Regulatory barriers hindering biosimilar market penetration.
- Patient and provider resistance to switching from branded to biosimilars.
- Market saturation and plateauing demand.
Key Takeaways
- Market stability for Glatiramer Acetate persists, benefiting from its long-term clinical experience.
- Price competition is intensifying, primarily through biosimilar entries, with potential for a 35-40% price reduction over the next five years.
- Manufacturers must navigate regulatory pathways, reimbursement dynamics, and physician preferences for successful market positioning.
- Stakeholders should monitor biosimilar approvals and formulary strategizing for optimal market access and cost management.
- Investors should consider the declining pricing trend while evaluating the longevity and competitive positioning of brand versus biosimilar products.
Conclusion
The market for NDC 51645-0870 (Glatiramer Acetate, Copaxone) is characterized by a mature landscape transitioning toward increased biosimilar penetration. While the branded formulation retains premium pricing due to entrenched clinical trust, ongoing market forces suggest a downward pricing trajectory with substantial cost reductions becoming evident through biosimilar integration. Stakeholders aligning their strategies with these dynamics are more likely to succeed amid evolving reimbursement, regulatory, and competitive environments.
FAQs
Q1: What factors most influence the price reduction of Glatiramer Acetate?
A: The expiration of patent protection, the entry of biosimilars and generics, competitive bidding by payers, and regulatory approval processes significantly influence price reductions.
Q2: How does biosimilar competition impact the market for NDC 51645-0870?
A: Biosimilars increase price competition, leading to substantial discounts and expanding access, but may also challenge the market share of the original branded product.
Q3: What are the primary advantages of biosimilar versions of Glatiramer Acetate?
A: Biosimilars typically offer comparable efficacy and safety profiles at approximately 30-50% lower cost, improving affordability and increasing patient access.
Q4: Could regulatory changes hinder biosimilar market growth?
A: Yes, new regulations or delays in biosimilar approvals could slow uptake, maintaining higher prices for the branded drug longer than expected.
Q5: What is the outlook for the future demand of Glatiramer Acetate?
A: Demand is expected to remain stable due to the chronic nature of MS and the enduring clinical trust in the drug, although some shift toward oral therapies might influence growth rates.
Sources:
[1] FDA Drug Database, 2023.
[2] National Multiple Sclerosis Society, 2022.
[3] Teva Pharmaceuticals Annual Report, 2022.
[4] IQVIA Report on MS Market, 2022.
[5] MedPAK Price Trends Report, 2022.
[6] GoodRx, 2023.
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