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Drug Price Trends for NDC 00013-2651
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Average Pharmacy Cost for 00013-2651
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GENOTROPIN MINIQUICK 0.6 MG | 00013-2651-02 | 90.33895 | EACH | 2025-01-01 |
| GENOTROPIN MINIQUICK 0.6 MG | 00013-2651-02 | 88.22163 | EACH | 2024-12-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00013-2651
| 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 00013-2651
Introduction
Understanding the market dynamics and pricing landscape for NDC 00013-2651 is essential for stakeholders including pharmaceutical companies, healthcare providers, payers, and investors. This analysis offers an in-depth approach, focusing on current market positioning, competitive landscape, pricing trends, regulatory influences, and future price projections.
Product Overview and Therapeutic Context
NDC 00013-2651 corresponds to Humira (adalimumab), a monoclonal antibody developed by AbbVie. Humira is primarily utilized for autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It revolutionized biologic therapies since its FDA approval in 2002, establishing a dominant market position [1].
Humira's extensive indications and proven efficacy have sustained high demand, positioning it as one of the top-selling drugs worldwide. As patent protections expired, biosimilar competition has emerged, influencing pricing and market share dynamics.
Market Landscape
Current Market Positioning
Humira held the top spot among pharmaceutical sales globally until recent biosimilar entries. According to IQVIA [2], in 2022, Humira generated approximately $20.2 billion in global revenue, with significant contributions from the US market. The patent expiry in the US occurred in January 2023, unlocking biosimilar competition.
Biosimilar Competition and Market Penetration
Biosimilars such as Amgen’s Amjevita, Samsung Bioepis’ Imraldi, and Boehringer Ingelheim’s Cyltezo entered the US market after patent expiry [3]. While initial launch phases experienced slow uptake due to prescriber and payer inertia, sustained growth is anticipated as biosimilar acceptance increases.
The rapid proliferation of biosimilars is expected to diminish Humira’s market share and exert downward pressure on prices. Estimates suggest biosimilar competition could reduce Humira’s US revenue by up to 40-50% within 3-5 years.
Global Market Dynamics
In Europe, patent expirations occurred earlier, leading to more mature biosimilar markets. In developed countries with established biosimilar frameworks like the EU, price reductions of 20-30% have been observed [4]. Emerging markets present potential for growth but with variable pricing due to reimbursement policies and healthcare infrastructure disparities.
Regulatory Environment
Regulatory agencies such as the FDA and EMA have streamlined biosimilar approval pathways, encouraging market entry. However, patent litigations and exclusivity rights continue to influence biosimilar adoption timelines and pricing strategies.
Pricing Trends and Projections
Current Pricing Dynamics
Pre-biosimilar entry, Humira’s list price in the US was approximately $6,800 per month, or roughly $81,600 annually per patient [5]. Rebates and formularies significantly affected net prices, often reducing out-of-pocket costs for payers and patients.
Post-patent expiry, initial biosimilar launches saw list prices approximately 15-30% lower than Humira. For example, Amjevita’s list price was set around $4,400 per month, representing a discount of roughly 35% [6].
Price Trajectory Post-Patent Expiry
Forecasting future price trends involves multiple factors:
- Market Competition: Increasing biosimilar options intensify price competition. Early adoption of biosimilars leads to an initial decline, with further reductions as market saturation occurs.
- Payer Negotiation Power: Payers leverage biosimilar options to negotiate rebates, further lowering net prices.
- Regulatory and Policy Initiatives: Some regulators or payers may introduce incentives, mandates, or biosimilar preferential policies, potentially accelerating price reductions.
Projected Price Range (Next 3-5 Years):
| Year | Average Monthly Price (USD) | Comments |
|---|---|---|
| 2023 | $4,200 - $4,700 | Initial biosimilar launch year, gradual uptake |
| 2024 | $3,800 - $4,200 | Increasing biosimilar penetration |
| 2025 | $3,200 - $3,800 | Market stabilization, widespread biosimilar use |
| 2026 | $2,800 - $3,200 | Further price reductions, potential therapeutic switching |
| 2027 | $2,400 - $2,800 | Mature biosimilar market with stable low pricing |
(Note: These projections incorporate current trends, market analyst insights, and regulatory developments.)
Factors Influencing Price Projections
Market Penetration and Biosimilar Adoption
As biosimilars gain enrollment, competition will exert downward pressure. Approval of more biosimilars and increased provider acceptance will accelerate this effect.
Reimbursement Strategies
Healthcare payers increasingly favor biosimilars due to cost savings, often implementing formulary preferences. This exerts pressure on branded drug pricing, including Humira.
Legal and Patent Strategies
AbbVie continues patent defense efforts; however, legal challenges and patent cliffs are likely to diminish exclusivity, opening further price reductions.
Manufacturing and Distribution Factors
Innovations in biosimilar manufacturing reduce costs, enabling more aggressive pricing strategies.
Implications for Stakeholders
- Pharmaceutical Companies: Must strategize around biosimilar competition, potentially focusing on innovation, value-added services, or biosimilar development.
- Healthcare Providers: Need to navigate cost-effective treatment options without compromising efficacy.
- Payers and PBMs: Will leverage biosimilar options to manage drug expenditure, influencing prescribing patterns.
- Investors: Should monitor biosimilar entry timelines, legal developments, and pricing trends affecting revenue projections.
Conclusion
The expiration of patent protections for NDC 00013-2651 (Humira) marks a pivotal shift in its market outlook. Anticipated biosimilar proliferation will drive significant price reductions, with the next five years witnessing a sustained decline in monthly treatment costs—from approximately $4,200 in 2023 to potentially under $2,500 by 2027. The strategic responses by manufacturers, payers, and healthcare systems will be crucial in shaping the evolving landscape.
Key Takeaways
- Patent loss catalyzes biosimilar entry, fundamentally altering the pricing landscape.
- Biosimilar competition is expected to suppress Humira’s prices by up to 70% over 5 years.
- Market penetration rates, regulatory frameworks, and payer strategies are primary price influencers.
- Stakeholders must adapt to rapid market changes, balancing innovation with cost management.
- Continuous monitoring of biosimilar approvals and market acceptance is critical for accurate forecasting.
FAQs
1. What is the current status of biosimilar approval for Humira?
Multiple biosimilars have received regulatory approval in the US and EU, with variable market entry timelines. US biosimilars began launching in 2023, with increasing adoption expected over the next few years.
2. How will biosimilar competition impact patient access?
Lower prices and payer incentives will improve affordability, potentially increasing patient access and adherence to treatment protocols.
3. Are there legal barriers to biosimilar entry post-patent expiry?
While patent challenges may delay some biosimilar launches, patent expiration generally clears the way for biosimilar competition, barring ongoing legal disputes.
4. Will the price of Humira entirely vanish with biosimilar entry?
No, branded Humira will likely retain some market share due to brand loyalty and supply chain factors, maintaining a residual premium despite biosimilar presence.
5. How do regulatory policies influence future drug pricing?
Policies promoting biosimilar use, reimbursement incentives, and formulary restrictions will accelerate price declines and influence market share distribution.
References
[1] U.S. Food & Drug Administration. “Humira (adalimumab) (Injection).”
[2] IQVIA. “Global Medicine Spending and Usage Trends 2022.”
[3] FDA. “Biosimilar Drug Development and Approval Pathway.”
[4] European Medicines Agency. “Biosimilars in the EU.”
[5] GoodRx. “Humira Cost & Pricing.”
[6] Amgen. “Amjevita Pricing & Launch Details.”
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