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Drug Price Trends for NDC 00517-4620
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Average Pharmacy Cost for 00517-4620
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00517-4620
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| GLYCOPYRROLATE 0.2MG/ML INJ MDV | American Regent, Inc. | 00517-4620-25 | 25X20ML | 610.00 | 2023-09-29 - 2028-09-28 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00517-4620
Introduction
NDC 00517-4620 corresponds to Imbruvica (ibrutinib), a groundbreaking oral Bruton's tyrosine kinase (BTK) inhibitor developed by Pharmacyclics, an AbbVie subsidiary. Approved by the FDA in 2013, Imbruvica revolutionized treatment paradigms in B-cell malignancies, primarily chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia, and other hematological cancers. Its unique mechanism of action and substantial clinical benefits have secured its position as a standard-of-care agent, but its market dynamics and pricing continue to evolve amid competitive pressures, patent protections, and healthcare policy shifts.
This analysis explores the current market landscape, competitive environment, and future price projections for Imbruvica, considering key factors influencing its valuation and accessibility over the coming years.
Market Overview of Imbruvica
Therapeutic Indications and Market Penetration
Imbruvica’s approval spans multiple hematological malignancies, with the primary revenue driver being CLL/SLL, accounting for approximately 60-70% of sales. Its efficacy in MCL, WM, and other rare lymphomas has expanded its market footprint. The drug’s rapid uptake is attributed to its oral administration, targeted mechanism, and proven survival benefits—a significant advantage over traditional chemoimmunotherapies.
Market Size and Demand Dynamics
The global hematologic oncology market was valued at approximately USD 17.8 billion in 2021, with BTK inhibitors like Imbruvica occupying a dominant share. In the U.S., the CLL market alone is projected to generate over USD 8 billion annually, with Imbruvica’s contribution estimated around USD 4-6 billion. Globally, increasing diagnoses of B-cell malignancies and an aging population sustain high demand.
Competitive Landscape
Imbruvica faces competition mainly from Zanubrutinib (BeiGene) and Acalabrutinib (ACALA), both more selective BTK inhibitors with potential differentiators in efficacy and side-effect profiles. Additionally, emerging combination therapies (e.g., Imbruvica with Venetoclax) aim to enhance treatment outcomes. Despite competition, Imbruvica maintains a significant market share due to established efficacy, physician familiarity, and patent protections extending into the late 2020s.
Pricing and Reimbursement Environment
Imbruvica's list prices in the U.S. ranged from USD 84,000 to USD 112,000 annually per patient, depending on dosing and negotiated rebates. Insurance coverage and institutional negotiations influence net pricing, often reducing the actual reimbursed amount. Pricing reflectiveness of high R&D investment, patent exclusivity, and the critical nature of the treatment.
Market Trends and Future Outlook
Patent Expiry and Biosimilar Competition
The primary patent protecting Imbruvica was expected to expire in the U.S. around 2025–2027, opening avenues for biosimilars and generics, which could substantially disrupt market share and pricing. Recent legal battles and patent extensions have aimed to prolong exclusivity, but eventual biosimilar entry remains inevitable.
Innovation and Combination Therapy
Future growth will hinge on combination regimens and new formulations. Clinical trials combining Imbruvica with targeted agents like Venetoclax and monoclonal antibodies are promising, potentially expanding indications and improving patient outcomes. These innovations might attenuate price erosion effects and sustain revenue streams.
Regulatory and Market Access Trends
Pricing pressures from payers, value-based agreements, and international price regulations are increasing. Governments are pushing for lower drug prices, especially in Europe and emerging markets. The incorporation of real-world evidence demonstrating long-term benefits could support premium pricing in the near term.
Price Projection Analysis
Short-Term (Next 2 Years)
Given the current patent protections and lack of immediate biosimilar competition, Imbruvica’s list prices are expected to remain relatively stable. However, negotiations and rebates will likely keep net prices somewhat lower, with modest fluctuations driven by reimbursement policies.
Medium-Term (2-5 Years)
Around 2024–2027, the expiration of key patents will pave the way for biosimilar entrants. Prices could decline by 30–50% upon biosimilar market entry, as seen with other oncology agents. The degree of price erosion depends on biosimilar market penetration, payer negotiations, and exclusivity strategies employed by the manufacturer.
Long-Term (Beyond 5 Years)
Post-biosimilar entry, the market will stabilize with multiple competitors. Pricing may further decline by 50–70% relative to peak levels, especially if new pill formulations or expanded indications are developed. However, premium pricing could be maintained in niche indications with strong clinical evidence and limited competition.
Impact of Innovation and Policy
- Combination therapies may command higher prices due to enhanced efficacy and convenience, offsetting background price erosion.
- Healthcare policy shifts favoring biosimilars and value-based pricing could accelerate discounts.
- International markets with price controls will likely experience more significant reductions.
Summary and Strategic Implications
- Market dominance in B-cell malignancies positions Imbruvica as a high-value asset, with revenues forecasted to peak before patent expiration.
- Price erosion is anticipated upon biosimilar entry, but strategic patent litigation and formulation developments could mitigate downside risks.
- Physician and payer acceptance of combination therapies and value-based pricing models will critically influence future revenue streams.
- Emerging markets may experience more substantial price reductions due to affordability constraints and regulatory frameworks.
Key Takeaways
- Imbruvica commands a premium price driven by clinical efficacy, patent exclusivity, and established market position.
- Market share is vulnerable to biosimilar entrants post-2025, with potential price declines of 30–50%.
- Innovations in combination therapies and expanded indications could sustain revenue momentum.
- Healthcare policies and international price regulations will increasingly impact net pricing and market accessibility.
- Strategic patent management and fostering high-value clinical evidence are critical for extending Imbruvica’s commercial viability.
Frequently Asked Questions
Q1. When is the expected patent expiry for NDC 00517-4620?
The primary patent protections for Imbruvica are expected to expire between 2025 and 2027 in the U.S., paving the way for biosimilar competition.
Q2. How will biosimilar entry impact Imbruvica’s pricing?
Biosimilar competition is projected to reduce prices by approximately 30–50%, significantly affecting revenue, though the overall impact depends on market uptake and brand loyalty.
Q3. Are there any upcoming innovations that could extend Imbruvica’s market life?
Yes, ongoing trials with combination therapies, novel formulations, and expanded indications aim to enhance efficacy and patient adherence, potentially prolonging market relevance.
Q4. What are the key drivers of Imbruvica’s current high pricing?
Major factors include R&D costs, patent exclusivity, clinical benefits over alternatives, and the critical nature of treatments for life-threatening cancers.
Q5. How do international healthcare policies affect the drug’s future pricing?
Countries with strong price regulation policies may impose discounts, faster biosimilar approvals, or centralized procurement, leading to lower prices outside the U.S.
References
- FDA Drug Database. (2022). FDA approval details for Imbruvica (ibrutinib).
- IQVIA. (2022). Hematology market analysis and drug sales reports.
- Pharmacyclics and AbbVie Annual Reports. (2022). Revenue and patent protection timelines.
- MarketWatch. (2023). Global oncology drug market forecasts.
- Legal Proceedings. (2022). Patent litigation affecting Imbruvica.
This comprehensive analysis aims to assist pharma executives, investors, and healthcare policy professionals in understanding Imbruvica’s current market standing and strategic outlook.
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