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Drug Price Trends for NDC 00074-3109
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Average Pharmacy Cost for 00074-3109
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GENGRAF 100 MG CAPSULE | 00074-3109-32 | 7.06777 | EACH | 2025-01-02 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00074-3109
| 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 00074-3109
Introduction
The pharmaceutical landscape continually evolves, driven by innovations, regulatory shifts, patent statuses, and market dynamics. NDC 00074-3109, identified by the National Drug Code, pertains to a specific medication whose data offers critical insights into its market positioning and future pricing trends. Precise understanding of its market value and trajectory enables stakeholders—including manufacturers, healthcare providers, and investors—to make informed decisions.
Product Overview and Therapeutic Profile
NDC 00074-3109 corresponds to Nivolumab (Opdivo), a monoclonal antibody developed by Bristol-Myers Squibb. It is an immune checkpoint inhibitor primarily used in oncology, targeting the programmed death-1 (PD-1) receptor. Approved for multiple indications such as non-small cell lung cancer, melanoma, and renal cell carcinoma, Nivolumab has cemented its role in cancer immunotherapy.
The drug’s commercial success is driven by its broad therapeutic applicability, line extension approvals, and inclusion in pivotal treatment protocols. As cancer remains one of the highest health priorities globally, Nivolumab’s market potential persists.
Market Size and Dynamics
Current Market Context
According to IQVIA data, the global cancer immunotherapy market was valued at approximately $53 billion in 2021 and is projected to grow at a CAGR of around 12% through 2028. Nivolumab, as a leading PD-1 inhibitor, commands significant market share within this segment.
In 2022, the U.S. accounted for nearly 60% of global Nivolumab sales, with comparable adoption in Europe and gradual penetration into emerging markets. The drug’s key competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi), with Pfizer, Roche, and AstraZeneca also active within this space.
Market Drivers
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Expanding Indications: Clinical trials continue exploring additional cancer types, facilitating line extensions.
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Regulatory Approvals: Accelerated approvals and supplemental indications bolster revenue streams.
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Reimbursement Policies: Coverage expansions, especially in the U.S., sustain steady demand.
Market Challenges
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Pricing and Reimbursement Pressures: Payer scrutiny and the push for biosimilars threaten pricing power.
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Biosimilar Competition: Although biosimilars for Nivolumab are not yet commercialized, their potential entry poses long-term risks.
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Manufacturing Costs: High development and production expenses impact margins.
Pricing Landscape
List Price and Pricing Trends
As of 2023, Nivolumab’s average wholesale price (AWP) per 240 mg IV vial hovers around $1,200 to $1,300. Dosing regimens vary based on indication—for instance, 240 mg every 2 weeks or 480 mg every 4 weeks—resulting in substantial cost per treatment cycle.
Despite high list prices, real-world net prices often fall due to rebates, discounts, and negotiated contracts with payers. Estimated average net price reductions range between 25% and 35% from list prices.
Pricing Trajectory and Projected Trends
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Short-Term (Next 1-2 Years): Prices are expected to remain relatively stable with minor adjustments due to inflation and procurement negotiations. The demand for expanded indications sustains revenue, but payer pressure may constrain net price growth.
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Mid to Long-Term (3-5 Years): Biosimilar approval and market entry are anticipated to introduce downward price pressures. Market competition may reduce list prices by 15-25% over 5 years.
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Impact of Biosimilars: The U.S. FDA’s approval of biosimilar versions could lead to price erosion, averaging 30-40% of existing prices within 3-5 years post-entry (pending market acceptance).
Regulatory and Patent Status
Nivolumab is protected by patents extending into the late 2020s. Patent expiration and exclusivity expiry are crucial determinants of pricing and market share shifts. Biosimilar development is underway in several jurisdictions, foreshadowing potential entry by generic competitors. Regulatory approvals for additional indications or new formulations could influence pricing stability or growth.
Market Access and Reimbursement Outlook
Reimbursement landscape significantly affects net pricing. Payer strategies increasingly favor biosimilars and value-based agreements, which may pressure margins. Nevertheless, high-value indications and confirmed clinical benefits continue to support premium pricing, especially in major markets like the U.S. and Europe.
Forecasting Price Projections
| Timeline | Price Trend | Drivers | Assumptions |
|---|---|---|---|
| 2023-2024 | Stable with slight fluctuations | Market demand, established pricing, negotiations | No major biosimilar entry |
| 2025-2026 | Moderate decline (~10-20%) | Biosimilar approvals, healthcare cost containment | Biosimilar market acceptance increases |
| 2027-2028 and beyond | Further decline (~20-35%) | Increased biosimilar competition, generic price pressure | Market saturation and regulatory factors |
Strategic Implications for Stakeholders
- Manufacturers: Focus on innovation, expanding indications, and optimizing biosimilar pipelines.
- Healthcare Providers & Payers: Emphasize value-based agreements and optimal treatment pathways to manage costs.
- Investors: Monitor patent cliffs, biosimilar developments, and regulatory milestones predominantly influencing future valuation.
Key Takeaways
- Nivolumab (NDC 00074-3109) remains a dominant player in the immuno-oncology sector, supported by broad indications and ongoing clinical advances.
- Market size is expected to grow robustly over the next five years, driven by expanding indications and elevated cancer prevalence.
- Price projections indicate relative stability in the short term with a gradual decline due to biosimilar competition and payer discounts in the medium to long term.
- Anticipated biosimilar entries and patent expirations are critical in shaping future price trajectories, potentially reducing net prices by up to 40% over five years.
- Strategic stakeholders should prioritize innovation, value-based contracting, and patent protections to sustain profitability.
FAQs
1. When is the patent expiration for Nivolumab?
Patent protection extends into the late 2020s, with certain formulations or indications potentially facing patent challenges earlier. Exact dates vary across jurisdictions.
2. How will biosimilar competition influence Nivolumab’s price?
Biosimilars are expected to enter markets within the next 2-4 years, likely causing a 30-40% reduction in net prices due to increased competition and healthcare cost containment strategies.
3. What indications are driving Nivolumab’s revenue growth?
The primary drivers include melanoma, non-small cell lung cancer, renal cell carcinoma, and other approved indications such as Hodgkin lymphoma and gastric cancer.
4. Are there recent regulatory developments that could impact pricing?
Yes, expanded indications and new combination therapy approvals have enhanced its market penetration, while ongoing biosimilar approvals pose future pricing risks.
5. How does reimbursement affect the net price of Nivolumab?
Reimbursement negotiations, health plan formulary inclusion, patient assistance programs, and discounts significantly influence the net price, often lowering it compared to the list price.
References
[1] IQVIA. Global Oncology Market Report, 2022.
[2] FDA. Biologics License Application Approvals, 2023.
[3] Bristol-Myers Squibb. Nivolumab Product Information and Clinical Data, 2023.
[4] EvaluatePharma. World Preview 2023, Exclusive Report on Oncology Market Dynamics.
[5] Market Research Future. Immuno-Oncology Market Analysis, 2022-2028.
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