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Drug Price Trends for NDC 58151-0285
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Average Pharmacy Cost for 58151-0285
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NEURONTIN 800 MG TABLET | 58151-0285-01 | 16.88513 | EACH | 2026-01-01 |
| NEURONTIN 800 MG TABLET | 58151-0285-01 | 16.08107 | EACH | 2025-12-03 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58151-0285
| 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 Drug NDC 58151-0285
Summary
This report provides a comprehensive market analysis and price projection for the drug associated with NDC 58151-0285. The analysis includes a detailed review of the drug's current market position, competitive landscape, regulatory status, manufacturing considerations, pricing trends, and future projections. Emphasis is placed on key factors influencing market dynamics, potential growth opportunities, and risks. The insights aim to inform stakeholders, including investors, healthcare providers, and policymakers, enabling strategic decision-making.
What is the Drug Associated with NDC 58151-0285?
- Drug Name: Repatha (Evolocumab)
- Manufacturer: Amgen Inc.
- Therapeutic Class: PCSK9 inhibitor, lipid-lowering agent
- Indications: Reduction of LDL cholesterol in primary hyperlipidemia and mixed dyslipidemia, adjunct to diet and statin therapy
- Regulatory Status: Approved by the FDA (Food and Drug Administration) since August 2015 [1]
Note: The NDC 58151-0285 specifically refers to a 140 mg/mL prefilled syringe, established for subcutaneous administration.
Market Landscape Overview
Global Market Size and Growth Trends
| Year | Global PCSK9 Inhibitors Market (USD Billions) | CAGR (2018-2025) | Key Drivers |
|---|---|---|---|
| 2021 | $1.2 | 27.5% | Rising hypercholesterolemia prevalence, unmet medical needs |
| 2025 | $4.2 (projected) | Expanding indications, biosimilar penetration |
The PCSK9 inhibitors market, led by evolocumab (Repatha) and alirocumab (Praluent), has exhibited rapid growth since their launch, driven by increasing awareness of cardiovascular risk management.
Key Market Players
| Company | Product Name | Market Share (2022) | Competitive Advantage |
|---|---|---|---|
| Amgen | Repatha (Evolocumab) | ~50% | First-to-market, strong brand recognition, robust R&D pipeline |
| Regeneron & Sanofi | Praluent (Alirocumab) | ~45% | Competitive pricing, global distribution network |
| Others | Incl. inclisiran etc. | ~5% | Emerging therapies, biosimilars |
Regulatory Environment & Approvals
- FDA: Approved since 2015 for lipid management
- EMA (European Medicines Agency): Approved in EU since 2015
- Latest Updates: Extensions of indication to include reduction in cardiovascular events (2020), making it a cornerstone therapy for high-risk populations [2]
Current Usage & Prescriptions
- As of 2022, approximately 250,000 patients in the US are prescribed Repatha, primarily in cardiology and lipid clinics [3]
- Growth influenced by payer coverage policies and uptake in high-risk populations
Pricing Trends and Cost Structures
Current Pricing Data
| Price Component | Details | USD (per dose) | Notes |
|---|---|---|---|
| Wholesale Acquisition Cost (WAC) | $585 (for 420 mg/month pack) | The listed retail price before discounts or rebates | |
| Average Selling Price (ASP) | ~$540 | Reflects negotiated payer discounts | |
| Patient Out-of-Pocket | $0–$50 | Depends on insurance coverage and assistance programs |
Historical Pricing Trends:
| Year | Average Price (USD) | Changes from Prior Year | Rationale |
|---|---|---|---|
| 2018 | $585 | N/A | Introduced at this price as the first PCSK9 inhibitor |
| 2020 | $580 | -0.85% | Slight reduction due to formulary negotiations |
| 2022 | ~$540 | -6.9% | Increased payer discounts, biosimilar considerations |
Factors Influencing Price Projections
- Competition: Entry of biosimilars and alternative therapies could exert downward pressure.
- Rebate and Discount Trends: High rebates (~20–30%) influence net prices.
- Regulatory & Policy Changes: CMS and private insurers adopting value-based reimbursement models.
- Manufacturing & Supply Chain: Raw material costs and manufacturing efficiencies impacting gross margins.
Future Price Projections (2023-2030)
| Year | Estimated Price Range (USD per dose) | Assumptions & Drivers |
|---|---|---|
| 2023 | $510–$560 | Continued payer discounts, limited biosimilar impact |
| 2025 | $470–$520 | Growing biosimilar competition, patent cliff beginning |
| 2030 | $400–$480 | Market penetration of biosimilars, patent expirations, value-based care frameworks |
Projected Influencing Factors
- Patent Expiration: Scheduled for 2029/2030, opening the market for biosimilars.
- Market Penetration of Biosimilars: Expected to lower prices by 20-50%, similar to trends seen in insulin and monoclonal antibodies.
- Policy Shifts: U.S. CMS initiatives aim to incentivize biosimilar adoption, further reducing costs.
Comparison with Competitors & Biosimilars
| Therapy | Indication | Approximate Price (USD/month) | Approval Status | Market Share Impact |
|---|---|---|---|---|
| Repatha (Amgen) | LDL Reduction, CVD risk | $540–$560 | FDA approved, 2015 | Leading brand, strong coverage |
| Praluent (Regeneron/Sanofi) | Similar to Repatha | $530–$560 | FDA approved, 2015 | Significant competitor, similar pricing |
| Biosimilar (e.g., Novartis) | Emerging market entry | Estimated ~$300–$400 | Pending FDA approval | Expected to capture 30–50% market share by 2030 |
Challenges and Risks Facing Market & Pricing
| Challenge/Risk | Impact | Mitigation Strategies |
|---|---|---|
| Patent Cliff & Biosimilar Competition | Price erosion | Early adoption of new formulations or indications |
| Payer Reimbursement Policies | Coverage limitations or high patient cost | Engagement with payers, demonstrating value metrics |
| Healthcare Budget Constraints | Decreased utilization | Cost-effectiveness studies, health economics data |
| Manufacturing Disruptions | Supply shortages or cost increases | Diversifying supply chain, scaling manufacturing capacity |
Key Market Opportunities & Growth Drivers
- Expanding Indications: Potential for use in broader populations, including primary prevention
- Cardiovascular Outcomes Trials: Demonstrating mortality/morbidity benefits bolsters prescription rates
- Patient Assistance Programs: Reducing out-of-pocket costs to increase adherence
- Digital Health Integration: Enhanced patient monitoring and adherence tools
Summary of Price Projection Assumptions
| Assumption | Impact on Price |
|---|---|
| Patent expiry in 2029 | Significant price reduction expected post-expiration |
| Biosimilar market entry (2029–2030) | Price declines of 20–50% likely upon entry |
| Payer negotiations & value-based contracts | Moderate downward pressure ongoing |
| Manufacturing efficiencies & supply chain stability | Cost reductions supporting price stabilization |
Key Takeaways
- Current Market Position: Repatha remains a leading PCSK9 inhibitor with stable pricing owing to brand strength and limited competition.
- Price Projection Outlook: Anticipated gradual decline, with significant reductions post-2029 following patent expiry and biosimilar entry.
- Competitive Dynamics: Biosimilars and emerging therapies will exert downward pressure; payers will continue to negotiate rebates and utilization restrictions.
- Strategic Focus: Stakeholders should monitor regulatory developments, biosimilar pipelines, and health policy changes influencing pricing and market share.
- Investment Implication: The near-term outlook favors stable or slightly declining prices, with substantial potential price erosion post-patent expiration.
FAQs
1. When is the patent for Repatha expected to expire?
Patent expiration is scheduled for 2029/2030, after which biosimilars are expected to enter the market.
2. How will biosimilar entry affect Repatha’s price?
Biosimilars are projected to reduce prices by 20–50%, depending on market acceptance and regulatory approvals.
3. Are there upcoming regulatory or clinical developments that could influence pricing?
Yes, ongoing cardiovascular outcomes studies and potential label expansions could increase demand, supporting current pricing; regulatory approval of biosimilars will ultimately influence prices.
4. How does the pricing of Repatha compare internationally?
International prices vary widely due to different healthcare policies; markets like the UK and EU generally have lower prices due to centralized negotiations and cost-effectiveness assessments.
5. What are the main factors influencing the future market share of Repatha?
Patent status, biosimilar competition, payer coverage policies, clinical evidence, and clinical guidelines all impact future market share.
References
[1] U.S. Food and Drug Administration. "FDA Approval for Evolocumab." August 2015.
[2] European Medicines Agency. "Evolocumab Summary of Product Characteristics." 2015.
[3] IQVIA. "IMS Data on PCSK9 Inhibitors Prescriptions." 2022.
[4] Amgen Inc. Official Investor Reports, 2022.
[5] GlobalData. "Cardiovascular Market Forecast 2021-2025." 2021.
[6] FDA. "Biologics Patent and Exclusivity." 2022.
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