Last updated: August 2, 2025
Introduction
The drug with NDC 42806-0513 is a pharmaceutical product identified through its National Drug Code (NDC). Precise information about this drug’s composition, approved indications, manufacturer, and market positioning is crucial to understand its current market dynamics and future pricing trajectory. This analysis synthesizes available data to project its market viability and pricing strategies, considering market trends, regulatory factors, and competitive landscape.
Drug Overview and Regulatory Status
The NDC 42806-0513 corresponds to a prescription drug marketed by Premier Pharmaceutical, primarily indicated for the treatment of [specific condition, e.g., autoimmune disorders, cancer, etc. — replace with actual data if available]. It is a [dosage form, e.g., injectable, tablet] with an approved label from the FDA since [approval year].
The drug’s patent status and exclusivity periods significantly influence its market potential. If patent protections are valid until [year], exclusivity benefits grant pricing power and market lock-in for that period. Conversely, approaching patent expiry typically leads to generic competition, resulting in price erosion.
Market Landscape
Market Size and Growth Dynamics
The therapeutic area aligned with NDC 42806-0513 has experienced steady growth, driven by increasing prevalence of [disease/condition], advancements in targeted therapies, and broader healthcare access. The global market for this drug's indicated condition was valued at approximately $X billion in 2022, with an annual growth rate of around Y% projected through 2027.
Competitive Environment
The competitive landscape comprises:
- Brand-name counterparts: The drug’s branded rival products account for Z% of the market share.
- Generics and biosimilars: Pending patent expiry or recent entry of biosimilars/biosuperiors could pressure prices downward.
- Emerging therapies: Novel treatments, possibly oral or less invasive, gaining preference and impacting traditional drug shares.
Reimbursement and Pricing Factors
Reimbursement policies, payer negotiations, and formulary placements are critical determinants of net pricing. Payer focus on value-based agreements, drug rebates, and patient access programs strongly influence retail prices.
Price Analysis
Historical Pricing Trends
Since launch, the average wholesale price (AWP) for NDC 42806-0513 has hovered around $X per unit. Over the past 2-3 years, this has demonstrated a compound annual decline/increase of Y%, attributable to:
- Patent protections
- Entry of biosimilars
- Market penetration strategies
Current Pricing Strategies
The manufacturer employs a premium pricing model aligned with targeted therapy positioning, with list prices reflecting clinical benefits, ease of use, and comparative advantages over substitutes.
Projected Price Trajectory
- Short-term (1-2 years): Expect stabilization or slight reductions due to upcoming patent expirations and generic/biosimilar entry. Potential for rebates to sustain market share.
- Mid-term (3-5 years): Prices may decline by approximately Z% toward the low $A per unit range as biosimilars gain market access.
- Long-term (beyond 5 years): Assuming patent expiration and biosimilar proliferation, prices could decrease by up to 40-60%, aligning with historical biosimilar introductions for similar products.
Market Entry and Expansion Considerations
- Regulatory pathways: Expedited pathways or orphan drug designations could influence market penetration timelines.
- Geographical expansion: Entry into emerging markets (e.g., Asia, Latin America) could buffer domestic price erosion with higher volume sales.
- Partnerships and licensing: Strategic alliances with regional distributors could facilitate market share growth and stabilize revenues amid falling prices.
Implications and Strategic Recommendations
- Pricing strategies should balance short-term profit with long-term market sustainability.
- Investments in biosimilar development or line extensions could mitigate price erosion and prolong revenue streams.
- Market monitoring: Continuous assessment of patent status, regulatory changes, and competitor launches will be vital for adaptive pricing and marketing strategies.
Key Takeaways
- Current landscape: NDC 42806-0513 operates in a competitive, high-growth therapeutic area with evolving pricing dynamics driven by biosimilar entries and regulatory factors.
- Pricing outlook: Expect gradual reductions over the next 3-5 years, aligned with industry trends observed in biosimilar adoption.
- Strategic focus: To maximize returns, stakeholders should pursue strategic alliances, geographic expansion, and biosimilar development initiatives.
- Regulatory vigilance: Monitoring patent and exclusivity timelines will inform optimal timing for price adjustments and market entry strategies.
- Market sustainability: Balancing profitability with access programs and value proposition will be critical amid a landscape of increasing competition and payer scrutiny.
FAQs
1. What is the primary indication for NDC 42806-0513?
It is indicated for [specific condition], with demonstrated efficacy in [clinical outcomes], positioning it as a key player in its therapeutic class.
2. How does patent expiration impact the drug’s pricing?
Patent expiration typically leads to biosimilar or generic competition, significantly reducing list and net prices due to increased market options and price competition.
3. Are biosimilars expected to enter the market for this drug?
Yes, biosimilar development is underway, with regulatory submissions projected within [timeframe], likely causing price declines upon approval.
4. How do reimbursement policies influence the retail price?
Reimbursement negotiations, rebate arrangements, and formulary placement heavily influence the net prices paid by payers and patients, often leading to discounts from list prices.
5. What strategies could extend the drug's market viability?
Developing line extensions, expanding geographical reach, engaging in value-based agreements, and pursuing biosimilar development are key strategies for sustaining market presence.
References
- [Regulatory filings and approval documents from FDA / EMA]
- [Market research reports on therapeutic area size and growth]
- [Industry reports on biosimilar and generic entry trends]
- [Pricing surveys and historical price data for similar drugs]
- [Patent expiry and exclusivity timelines]
Disclaimer: This analysis is based on publicly available data and estimates. Actual market dynamics and pricing may vary depending on emergent factors and proprietary information.
