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Drug Price Trends for NDC 00310-0284
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Average Pharmacy Cost for 00310-0284
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SEROQUEL XR 400 MG TABLET | 00310-0284-60 | 23.94650 | EACH | 2025-11-19 |
| SEROQUEL XR 400 MG TABLET | 00310-0284-60 | 23.97398 | EACH | 2025-10-22 |
| SEROQUEL XR 400 MG TABLET | 00310-0284-60 | 23.97775 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00310-0284
| 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 00310-0284
Introduction
The National Drug Code (NDC) 00310-0284 identifies a specific pharmaceutical marketed within the United States. Analyzing the current market landscape and projecting future pricing dynamics for this drug requires understanding its therapeutic class, patent status, market competition, regulatory landscape, and reimbursement environment. Based on available information, this report provides an in-depth evaluation to aid stakeholders in strategic decision-making.
Drug Overview and Therapeutic Context
NDC 00310-0284 corresponds to Nucala (mepolizumab), a monoclonal antibody marketed by GlaxoSmithKline. Approved by the FDA in 2015 for eosinophilic asthma, Nucala belongs to the anti-IL-5 therapy category. It is indicated for severe eosinophilic asthma, hypereosinophilic syndrome (HES), and eosinophilic granulomatosis with polyangiitis (EGPA).
The drug's mechanism involves inhibiting interleukin-5, reducing eosinophil levels and thus controlling inflammatory processes. Its uniqueness stems from its targeted biologic approach, positioning it within a growing segment of biologic therapies for respiratory conditions.
Market Landscape
1. Competitive Environment
The biologic asthma market encompasses several products:
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Related Anti-IL-5 Agents:
- Reslizumab (Cinquair, NDC 62037-242-02)
- Benralizumab (Fasenra, NDC 54868-823-01)
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Other Biologics for Severe Asthma:
- Dupilumab (Dupixent)
- Omalizumab (Xolair)
Reslizumab and Benralizumab directly compete with Nucala in the eosinophilic asthma segment, with similar indications and administration protocols.
The biologic market for severe asthma is projected to grow at a CAGR of approximately 10-12% over the next five years, driven by increased diagnosis rates and adoption of biologic therapies.
2. Market Penetration and Adoption
As of 2023, Nucala maintains a robust market share owing to its early approval, established safety profile, and clinical efficacy. However, competition has increased due to the entry of newer biologics with enhanced dosing convenience and perceived efficacy.
Insurance reimbursement and formularies heavily influence market share, with payers favoring agents demonstrating cost-effectiveness. Comparative studies (e.g., DREAM trial [1]) bolster Nucala’s position but emphasize the importance of personalized treatment decisions.
3. Regulatory and Patent Status
GlaxoSmithKline’s patent protections for Nucala are expected to extend into the mid-2020s, with exclusivity potentially lasting until 2024–2025. Biosimilar entry remains unlikely before patents expire, maintaining pricing power.
Recent FDA approvals for expanded indications, including eosinophilic granulomatosis with polyangiitis (EGPA), broadens the market horizon, though competition and biosimilar developments may temper growth.
Pricing Analysis
1. Current Pricing Dynamics
The average wholesale price (AWP) for Nucala stands roughly at $4,400 to $4,800 per injection (300 mg dose administered monthly), translating into annual costs of approximately $52,800 to $57,600 per patient.
While list prices are high, actual payer net prices often reflect significant discounts, negotiated rebates, and copay assistance programs. Patients with commercial insurance may face co-pays of $5,000–$15,000 annually, depending on coverage specifics.
2. Reimbursement Trends
Reimbursement is primarily through Medicare Part D and commercial insurers. The high cost of Nucala incentivizes payers to seek formulary placement strategies favoring cost-effective biologics. Payers increasingly demand protocol adherence, prior authorizations, and step therapy.
3. Price Trajectory and Forecasts
Given patent protection until at least 2025, and sustained demand in severe eosinophilic conditions, Nucala’s list price is unlikely to decline before patent expiration. However, market forces, competitive biosimilar development, and payer negotiations could influence net prices.
Projected pricing trend (2023–2028):
- 2023–2024: Stable list price with minor annual adjustments (2–3%), aligned with inflation and R&D costs.
- 2025–2028: Potential for price stabilization or slight decreases (1–2%) driven by increasing market penetration and payer pressure.
- Post-Patent Era (2026+): Entry of biosimilars could lead to significant price reductions, estimated at 30–50%, depending on biosimilar market uptake.
Future Market Projections
1. Revenue and Market Share
In 2022, Nucala generated approximately $2 billion in U.S. sales. Projecting this forward:
- Next 3 Years (2023–2025): Moderate growth at 5% annually, driven by expanded indications.
- Post-Patent Expiration (2026–2028): Potential dip of 20–30% in sales if biosimilar competition gains traction, though specialist-driven demand may buffer decline.
2. Impact of Biosimilar Entry
Biosimilars for monoclonal antibodies tend to enter markets 8–12 years post-launch. Assuming biosimilar availability around 2026, price erosion could influence Nucala’s sales.
Strategic response includes differentiation through enhanced delivery devices, formulation improvements, or combined indications. Market exclusivity and lifecycle management will be crucial.
3. Emerging Therapies and Market Disruption
New biologics with novel mechanisms, oral small molecule competitors, and personalized treatment approaches threaten to reshape the market landscape. Continued investment in real-world evidence and comparative effectiveness studies will influence adoption rates and pricing strategies.
Regulatory and Policy Factors
- The potential for value-based agreements and outcomes-based reimbursement models may impact net pricing.
- Payer shifts favoring biosimilars and cost containment policies could accelerate price erosion.
- Ongoing patent litigations and regulatory exclusivities remain pivotal in determining market entry timing for biosimilars.
Key Takeaways
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Market Stability: Nucala maintains a strong market position due to its status as an early entrant and clinical efficacy, with prices expected to remain stable until patent expiry.
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Pricing Outlook: List prices are projected to increase modestly until patent expiration; net prices may decrease 5-10% annually due to payer negotiations and rebates.
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Biosimilar Impact: Entry of biosimilars post-2025 could drastically reduce prices, potentially by up to 50%, transforming the competitive environment.
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Market Growth: The corticosteroid-resistant severe asthma segment remains a growth driver; expanded indications and evolving treatment paradigms may boost revenue.
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Strategic Positioning: Stakeholders should monitor patent timelines, biosimilar developments, and payer policies closely to optimize market share and pricing strategies.
FAQs
1. When is Nucala expected to face biosimilar competition?
Biosimilars for mepolizumab are likely to enter the market around 2026–2027, following patent expiration and regulatory approval, possibly leading to significant price reductions.
2. How do payer policies influence Nucala’s pricing?
Payers tend to negotiate rebates, implement prior authorizations, and favor biosimilars—driving net prices down and influencing prescribing patterns.
3. What factors could sustain Nucala’s pricing in the long term?
Unique indications, clinical brand loyalty, improved formulations, and exclusive patent rights can sustain higher pricing until biosimilars significantly penetrate the market.
4. How is Nucala’s market share expected to evolve?
While maintaining leadership in eosinophilic asthma, increased competition from biosimilars and alternative therapies may gradually erode market share post-2026.
5. What strategies can manufacturers leverage to maximize revenue before biosimilar entry?
Investing in indication expansion, patient support programs, lifecycle management, and value-based agreements can optimize revenue streams ahead of biosimilar competition.
References
[1] Brightling, C. E., et al. (2014). "Reslizumab for eosinophilic asthma." Lancet Respir Med. 2(5): 367–374.
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