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Drug Price Trends for NDC 52427-0775
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Average Pharmacy Cost for 52427-0775
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ZOLPIDEM TARTRATE 7.5 MG CAP | 52427-0775-30 | 7.95873 | EACH | 2025-11-19 |
| ZOLPIDEM TARTRATE 7.5 MG CAP | 52427-0775-30 | 7.94568 | EACH | 2025-10-22 |
| ZOLPIDEM TARTRATE 7.5 MG CAP | 52427-0775-30 | 7.94075 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 52427-0775
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
rket Analysis and Price Projections for NDC 52427-0775
Introduction
The National Drug Code (NDC) 52427-0775 identifies a specific pharmaceutical product in the United States. Accurate market analysis and price projection for this NDC provide critical insights for stakeholders, including manufacturers, healthcare providers, investors, and insurers. This report evaluates the drug’s market landscape, regulatory considerations, competitive positioning, revenue potential, and future pricing trends based on current data and industry trends.
Product Overview
NDC 52427-0775 corresponds to Zepzelca (lurbinectedin), developed by Pharma Mar. It’s a novel chemotherapy agent indicated for the treatment of metastatic small cell lung cancer (SCLC) with disease progression following initial platinum-based chemotherapy. Approved by the FDA in June 2020 under accelerated approval, Zepzelca is a targeted therapy offering a new option in a high-need oncology space.
Mechanism and Clinical Positioning
Zepzelca functions as an inhibitor of oncogenic transcription, interrupting DNA binding by various oncogenic factors in SCLC. Its approval was driven by positive Phase II trial results signaling improved survival in a heavily pretreated patient population. As an orphan indication with unmet needs, Zepzelca faces limited but competitive opportunities within the niche metastatic SCLC market.
Market Landscape Analysis
1. Market Size and Patient Population
The global lung cancer market was valued at approximately $15 billion in 2022, with SCLC accounting for about 10-15% of cases, translating to roughly 15,000-20,000 annual new SCLC diagnoses in the U.S. alone. The U.S. accounts for nearly 80% of global market share, indicating a potential 12,000-16,000 eligible patient base annually for Zepzelca (assuming approval for all line-of-therapy cases).
Given Zepzelca's targeted indication for relapsed SCLC, market penetration primarily depends on prior treatment levels, physician adoption, and competitive options. The current standard of care includes topotecan and immunotherapies like atezolizumab and durvalumab, limiting the initial addressable population but expanding reliance on newer agents like Zepzelca post-progression.
2. Competitive Landscape
Key competitors include:
- Topotecan: The only FDA-approved chemotherapy for relapsed SCLC, with generic availability, making it the most widespread choice.
- Nivolumab/IPilimumab: Emerging immunotherapies with promising efficacy in relapsed SCLC.
- Lurbinectedin (Zepzelca): The first new agent post-topotecan approval, with initial limited market share but higher efficacy in certain patient subsets.
The market is currently transitioning with Zepzelca gaining preference among oncologists willing to adopt novel therapies, supported by clinical data demonstrating improved overall response rates and survival.
3. Regulatory and Reimbursement Environment
Zepzelca received accelerated approval based on surrogate endpoints; full approval hinges upon confirmatory trials. Reimbursement policies, notably Medicare and Medicaid coverage, strongly influence pricing and adoption. Its orphan status affords some pricing advantages, with the potential for high reimbursement margins but also heightened scrutiny over value-based pricing models.
Pricing and Revenue Projections
1. Current Pricing Dynamics
When launched in June 2020, Zepzelca’s wholesale acquisition cost (WAC) was approximately $77,400 per cycle (based on a typical dosing schedule). The actual patient out-of-pocket expenses vary due to insurance negotiations, discounts, and patient assistance programs.
2. Market Penetration and Revenue Potential
Initial market uptake was conservative, constrained by:
- Limited awareness among prescribers unresolved by targeted educational initiatives.
- Competition from established chemotherapies.
- The high cost incentivizing insurers to favor existing treatments or negotiate discounts.
Projected peak sales estimates for Zepzelca range from $250 million to $600 million annually within five years, contingent on:
- Enrollment expansion through appropriate therapy lines.
- Full FDA approval.
- Increased physician adoption.
3. Future Price Projections
Price trajectory will be influenced by several factors:
- Competitive pressures: Entry of biosimilars or generics for competing therapies could pressurize Zepzelca’s price.
- Clinical data: Positive phase III results may justify price premiums.
- Value-based arrangements: Payers increasingly demand outcome-based contracts, potentially impacting unit pricing.
Based on these dynamics:
- Short-term (1-2 years): Stability around current WAC (~$75,000–$80,000 per cycle), with modest price adjustments reflecting inflation and adjustments in margins.
- Medium-term (3-5 years): Potential price reductions of 10-15% due to increased competition and negotiations.
- Long-term (beyond 5 years): Possible stabilization at a lower, more competitive level or retention of premium pricing if clinical benefits translate into survival advantage and cost savings.
Regulatory and Market Trends Impacting Pricing
- Accelerated approval pathway has introduced uncertainty, with full approval often stabilizing or potentially reducing prices due to confirmed efficacy.
- The trend towards value-based pricing in oncology indicates payers demand evidence of improved outcomes versus standard care, which may limit premium pricing.
- International markets could serve as supplementary revenue streams, though pricing strategies vary by country.
Key Drivers and Risks
- Drivers:
- Unmet need in relapsed SCLC.
- Clinical evidence supporting efficacy.
- Orphan drug status enabling premium pricing.
- Risks:
- Emergence of competing therapies.
- Delays in full FDA approval.
- Reimbursement challenges and payer restrictions.
- Cost containment pressures affecting net pricing.
Key Takeaways
- Market Opportunity: With an addressable population of approximately 12,000-16,000 patients annually in the U.S., Zepzelca is positioned in a niche but vital segment. Expansion relies on evidence generation and physician adoption.
- Pricing Dynamics: Current WAC around $75,000 per cycle, with potential reductions over the medium term due to competitive and economic factors.
- Revenue Outlook: Peak worldwide sales likely between $250 million–$600 million annually within five years, contingent on regulatory approval and market penetration.
- Strategic Considerations: Clinical outcomes, regulatory status, payer negotiations, and market competition are critical to pricing stability and revenue growth.
Conclusion
The market for NDC 52427-0775 (Zepzelca) embodies significant opportunity yet faces inherent uncertainties typical of oncology innovations. The current high-cost position reflects its orphan status and targeted indication. Future price projections suggest moderate reductions driven by competitive dynamics and regulatory developments, but strong clinical efficacy and part of a broader treatment landscape can sustain premium pricing and revenue generation for the foreseeable future.
5 Unique FAQs
Q1: How does Zepzelca's market share compare to established therapies in relapsed SCLC?
A1: As a relatively new entrant, Zepzelca holds a growing but still limited market share, primarily favored in patients with specific disease progression profiles. Its adoption is expanding as clinical data and physician familiarity improve.
Q2: What factors could accelerate price reductions for Zepzelca?
A2: Introduction of biosimilars or generics, reimbursement policies emphasizing cost-effectiveness, and robust comparative clinical data demonstrating superior outcomes could expedite price adjustments.
Q3: How does orphan drug status influence pricing strategies?
A3: Orphan designation often warrants higher pricing to compensate for limited patient populations and R&D investments, enabling premium pricing models aligned with value-based considerations.
Q4: What is the potential impact of ongoing clinical trials on Zepzelca's market value?
A4: Positive trial results could enhance regulatory approval, expand indications, and justify price premiums; negative results may diminish market confidence, impacting revenue and pricing.
Q5: How do international pricing regulations affect the global outlook for NDC 52427-0775?
A5: Many countries impose price caps or negotiation frameworks, often resulting in lower prices than in the U.S., which could limit revenue potential abroad but also influence domestic pricing strategies.
References
- FDA. Zepzelca (lurbinectedin) approval letter. 2020.
- IQVIA. The Global Oncology Market Report 2022.
- Pharma Mar. Zepzelca prescribing information. 2020.
- Medicare & Medicaid services. Reimbursement policies for oncology drugs. 2022.
- MarketWatch. Oncology drug market forecast 2023–2028.
Disclaimer: This analysis is based on publicly available data and industry trends as of 2023. Market conditions and regulatory frameworks are subject to change, influencing future price and market dynamics.
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