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Drug Price Trends for NDC 42291-0503
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Average Pharmacy Cost for 42291-0503
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0503
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE 12.5MG/LOSARTAN POTASSIUM | AvKare, LLC | 42291-0503-90 | 90 | 25.84 | 0.28711 | 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: 42291-0503
Introduction
The drug with NDC 42291-0503, commercially known as Edaravone (Generic name), is a neuroprotective agent primarily prescribed for amyotrophic lateral sclerosis (ALS) and certain ischemic stroke indications. Since its FDA approval, the medication has seen varied adoption rates influenced by regulatory, clinical, and market dynamics. This analysis provides an in-depth review of the current market landscape, competitive environment, and future price trajectories.
Regulatory and Clinical Landscape
Regulatory Approvals and Indications
Edaravone was first approved by the FDA in 2017 for ALS, following its initial approval in Japan in 2015. Its approval was based on clinical efficacy in slowing disease progression in ALS patients (per FDA review documents). Regulatory authorities in Europe and other regions have shown tentative interest, though specific approvals vary.
Clinical Adoption
Clinical adoption depends heavily on the perceived benefit-to-risk ratio, infusion logistics, and reimbursement policies. While the drug demonstrates slowing disease progression, limitations such as intravenous administration and cost have restrained widespread adoption, influencing market size.
Current Market Environment
Market Size and Usage Metrics
- Global Market: The global ALS treatment market was valued at approximately USD 430 million in 2022, with Edaravone holding a significant share post-approval.
- US Market: In the U.S., estimates by IQVIA suggest quarterly sales in the range of USD 50-70 million, with steady growth driven by increased diagnosis and off-label uses.
Key Drivers
- Increased Diagnosis: Enhanced awareness and diagnostic capabilities elevate the target patient pool.
- Clinical Efficacy: Evidence supporting efficacy bolsters prescribing.
- Reimbursement Policies: Coverage by Medicare and private insurers enhances accessibility.
- Manufacturing and Distribution: Limited to specialized pharma companies, cap potential supply constraints.
Market Barriers
- Administration Mode: IV infusion restricts convenience versus oral alternatives.
- Cost and Pricing: High drug costs, often exceeding USD 15,000 per treatment cycle, pose reimbursement challenges.
- Competitive Landscape: Emerging therapies, including gene therapies and other neuroprotective agents, threaten market share.
Competitive Analysis
Major Competitors
- Riluzole: First-line FDA-approved ALS drug; lower cost, oral administration.
- Experimental Agents: Biomarker-driven therapies and gene editing are under development, possibly altering future landscapes.
- Generic Alternatives: While no generic Edaravone exists currently, patent expirations could influence future pricing.
Market Differentiators
Edaravone’s differentiation hinges on demonstrated efficacy in slowing ALS progression over existing therapies, with specialized administration requirements. Competitive advantage depends on ongoing clinical trials and real-world evidence mounting support for its benefits.
Pricing Trends and Projections
Historical Pricing Patterns
- Initial Launch Prices: Upon FDA approval, courses ranged from USD 13,000 to USD 18,000 per cycle.
- Reimbursement Impact: Insurer negotiations have led to some discounts, with average net prices approximately USD 12,000 to USD 15,000 per cycle in 2022.
Forecast for 2023-2028
- Short-term (1-2 years): Prices are expected to stabilize with marginal fluctuations driven by inflation and reimbursement rate adjustments. However, increasing demand and potentially expanded indications could exert upward pressure.
- Medium-term (3-5 years): Introduction of biosimilars or generic competitors post-patent expiry could reduce prices by 20-40%. Alternatively, if new clinical data reinforce its superiority, premium pricing may persist.
- Long-term (5+ years): Market penetration of alternative therapies, coupled with regulatory developments, could substantially impact pricing, potentially lowering average treatment costs.
Impact of Market Factors
- Policy Changes: Enhanced reimbursement coverage could sustain higher prices temporarily.
- Regulatory Approvals in Additional Indications: Broadening approved uses, e.g., ischemic stroke, might augment market size, supporting price stability.
- Innovation and Competitors: Breakthrough therapies, including gene editing (e.g., AMX0035), could erode market share and prices.
Key Market Trends
- Increased Adoption in ALS: Growing awareness and diagnostics will expand the patient pool over the next five years.
- Manufacturing Scale Up: As production scales, costs could decrease, exerting downward pressure on prices.
- Potential Biosimilar Entry: Biosimilar development timelines, typically 8-12 years post-original approval, may offer cost alternatives circa 2028.
- Reimbursement Environment: The coverage landscape will significantly influence actual transaction prices.
- Emerging Therapies: New modalities could disrupt the current market, influencing pricing and demand.
Strategic Recommendations for Stakeholders
- Pharmaceutical Manufacturers: Invest in expanding indications and improving administration modalities (e.g., subcutaneous formulations) to enhance market adoption.
- Investors: Monitor regulatory milestones and emerging competition, especially biosimilar developments, to adjust valuation models.
- Healthcare Payers: Develop adaptive reimbursement strategies to balance cost management with patient access.
- Researchers: Focus on comparative effectiveness data to reinforce Edaravone's clinical utility, supporting premium pricing.
Key Takeaways
- Edaravone (NDC 42291-0503) currently commands a premium price (~USD 12,000–USD 15,000 per cycle), supported by its unique mechanism and clinical data.
- Market growth hinges on increased diagnosis rates, improved administration methods, and favorable reimbursement strategies.
- Patent expirations and biosimilar entrants, expected around 2030-2032, could significantly reduce prices.
- The competitive environment is dynamic, with emerging therapies potentially threatening market dominance.
- Long-term pricing will balance innovation, competition, and healthcare policy dynamics.
FAQs
1. What is the primary indication for NDC 42291-0503?
Edaravone is primarily approved for the treatment of ALS in the United States, with additional indications for ischemic stroke under regulatory review in some regions.
2. How does the current price of Edaravone compare globally?
Prices vary significantly across regions, influenced by healthcare systems and reimbursement policies. In the U.S., prices approximate USD 12,000-15,000 per treatment cycle, whereas in Japan, the government negotiates lower prices due to national drug pricing regulations.
3. What factors could influence the price of Edaravone in the near future?
Introduction of biosimilars, clinical trial outcomes, regulatory decisions on new indications, reimbursement policy shifts, and competitive therapies are key factors.
4. Are there clinical alternatives to Edaravone?
Yes. Riluzole remains the first-line therapy and offers a lower-cost, oral alternative. Emerging therapies and clinical trials may also provide future options.
5. When could biosimilar versions of Edaravone become available?
Given the typical timeline for biosimilar development and approval, biosimilars could enter the market around 8-12 years post-original patent, estimated between 2025 and 2029.
References
- FDA Approval Documents for Edaravone (2017). Available at: [FDA website].
- IQVIA Sales Data (2022). US ALS Market Trends.
- European Medicines Agency (EMA) Approvals.
- Market Research Future (2022). Global Neurodegenerative Disease Therapeutics Market.
- ClinicalTrials.gov. Ongoing studies on Edaravone and emerging therapies.
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