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Drug Price Trends for NDC 58284-0264
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Average Pharmacy Cost for 58284-0264
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58284-0264
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| BRIXADI 64MG/0.18ML INJ,SA | Braeburn, Inc. | 58284-0264-01 | 0.18ML | 1208.54 | 6714.11111 | 2024-03-15 - 2029-03-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Patent Landscape and Market Projections for NDC 58284-0264
This report analyzes the patent landscape and projects market performance for the drug identified by National Drug Code (NDC) 58284-0264. The analysis focuses on key patent expirations, market exclusivity periods, and their potential impact on pricing and market entry for generic or biosimilar competitors.
What is NDC 58284-0264 and Its Therapeutic Area?
NDC 58284-0264 corresponds to Remicade (infliximab-dyyb), a biosimilar to Remicade (infliximab). Infliximab is a chimeric monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α). It is indicated for the treatment of various inflammatory and autoimmune diseases, including:
- Rheumatoid arthritis (RA)
- Psoriatic arthritis (PsA)
- Ankylosing spondylitis (AS)
- Crohn's disease (CD)
- Ulcerative colitis (UC)
- Plaque psoriasis (PsO)
Remicade was originally approved by the U.S. Food and Drug Administration (FDA) in 1998. Infliximab-dyyb, marketed as Inflectra by Pfizer and Remsima by Celltrion, is a biosimilar approved in 2016 [1]. Biosimilars are biological products that are highly similar to a U.S.-licensed reference biological product, with no clinically meaningful differences in terms of safety, purity, and potency.
What is the Patent Expiration Timeline for Remicade and Related Patents?
The patent landscape for biologicals like infliximab is complex, involving not only compound patents but also formulation patents, manufacturing process patents, and method-of-use patents. The original innovator product, Remicade, has seen significant patent expiries, allowing for biosimilar market entry.
Key Patent Expiration and Exclusivity Periods:
- Original Compound Patent: The primary patent covering the infliximab molecule itself has long expired.
- Formulation and Method-of-Use Patents: Various patents related to specific formulations, dosing regimens, and methods of treating specific conditions have been filed and pursued over the years. These have often been subject to legal challenges and have contributed to the extended exclusivity of the innovator product.
- Biosimilar Approvals: The first biosimilar to Remicade, infliximab-dyyb, received FDA approval on April 5, 2016 [1]. This approval signaled the commencement of the biosimilar competition era for this drug.
- Inter Partes Review (IPR) Proceedings: Numerous IPR challenges have been filed against patents held by the innovator company, Janssen Biotech, Inc. (a Johnson & Johnson company). These proceedings aim to invalidate or narrow the scope of patent claims. For instance, IPRs have targeted patents related to methods of treatment for Crohn's disease and ulcerative colitis.
- Patent Litigation: Litigation over patent validity and infringement is common in the biologics space. Settlement agreements, often including "pay-for-delay" provisions or authorized generics, can also influence market entry timelines and pricing strategies.
The precise expiry dates of all relevant patents are subject to ongoing legal interpretations and potential challenges. However, the broad market for infliximab is now open to biosimilar competition.
What is the Current Market Size and Share for Infliximab?
The market for infliximab is substantial, driven by its efficacy in treating chronic inflammatory conditions. The global market for TNF inhibitors, of which infliximab is a major player, was valued at approximately $50 billion in 2022 and is projected to grow [2].
Market Share Dynamics:
- Innovator (Remicade): While Remicade (infliximab) historically dominated the market, its market share has been eroded by the introduction of biosimilars. However, it still retains a significant portion, particularly in markets where biosimilar uptake may be slower or where physician and patient preferences favor the reference product.
- Biosimilars (e.g., Inflectra, Remsima): The market share of infliximab biosimilars has steadily increased since their introduction. Factors influencing this growth include:
- Price Competitiveness: Biosimilars typically offer a significant price advantage over the reference product.
- Payer Incentives: Pharmacy benefit managers (PBMs) and insurance companies often provide formulary preference for biosimilars through rebates and preferred placement.
- Physician Adoption: Increased physician awareness, clinical trial data demonstrating equivalent efficacy and safety, and formulary mandates have driven adoption.
- Direct-to-Consumer Advertising: While less prevalent for biosimilars compared to biologics, it can still play a role in patient awareness and requests.
- Regional Variations: Market penetration and adoption rates for biosimilars vary significantly by country and healthcare system. Countries with established biosimilar policies and robust uptake mechanisms, such as in Europe, have seen higher biosimilar market shares compared to the U.S.
Specific market share data for NDC 58284-0264 (which refers to the biosimilar infliximab-dyyb) is proprietary and varies by distributor and region. However, analyses indicate that biosimilars now capture a notable percentage of the overall infliximab market, a trend expected to continue.
What are the Projected Price Changes and Market Entry Impacts for NDC 58284-0264?
The introduction of biosimilars has a direct and significant impact on the pricing of both the reference product and the biosimilar itself.
Price Projections:
- Initial Biosimilar Pricing: When biosimilars first enter the market, they typically launch at a discount to the innovator product. This discount can range from 15% to 50% or more, depending on the competitive landscape, payer negotiations, and the perceived value proposition of the biosimilar.
- Price Erosion: As more biosimilars enter the market for the same reference product, price erosion accelerates. For infliximab, with multiple biosimilars now available, significant price reductions have already occurred.
- Reference Product Price Adjustments: The innovator company (Janssen) has likely adjusted its pricing strategy for Remicade to remain competitive against biosimilars. This often involves introducing authorized generics or offering discounts.
- Long-Term Price Stabilization: While initial price drops are steep, prices tend to stabilize over time as the market reaches a certain equilibrium of competition. However, ongoing innovation in manufacturing processes or new indications could lead to further price adjustments.
- Impact of NDC 58284-0264: As a biosimilar, NDC 58284-0264 (infliximab-dyyb) directly contributes to this price erosion. Its price is expected to be significantly lower than the original Remicade and will likely face downward pressure as other infliximab biosimilars gain market share or new biosimilar competitors emerge.
Market Entry Impacts:
- Increased Competition: The entry of biosimilars like infliximab-dyyb intensifies competition, leading to a broader range of treatment options for patients and healthcare providers.
- Cost Savings: A primary benefit of biosimilar market entry is the potential for significant cost savings for healthcare systems, payers, and patients. These savings can be reinvested in other areas of healthcare or allow for expanded access to treatments.
- Market Penetration: The rate of market penetration for biosimilars depends on various factors, including regulatory frameworks, payer policies, physician prescribing habits, and patient acceptance.
- Potential for Authorized Generics: The availability of authorized generics (products marketed by the innovator company under a different label) can further influence pricing and market dynamics.
- Supply Chain Dynamics: The introduction of biosimilars can also impact the pharmaceutical supply chain, requiring adjustments in manufacturing, distribution, and inventory management.
The pricing of biosimilars is not a static value. It is dynamic and influenced by a complex interplay of factors including the number of competitors, the cost of production, regulatory hurdles, and reimbursement policies of major payers.
What are the Key Regulatory Considerations and Market Access Strategies?
Navigating the regulatory landscape and securing market access are critical for the success of any pharmaceutical product, including biosimilars.
Regulatory Considerations:
- FDA Biosimilar Pathway: The U.S. FDA has established a pathway for the approval of biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). This pathway requires biosimilar applicants to demonstrate that their product is "highly similar" to the reference product and that there are no clinically meaningful differences in safety, purity, and potency.
- Interchangeability Designation: A key regulatory consideration is the designation of "interchangeability." An interchangeable biosimilar is one that the FDA has determined can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. This designation requires additional data demonstrating that the biosimilar can be expected to produce the same clinical result as the reference product in any given patient, and that the risks and benefits of using the interchangeable biosimilar are the same as for the reference product. While infliximab-dyyb (NDC 58284-0264) is a biosimilar, its interchangeability status with Remicade is a crucial factor for broader market adoption, especially in pharmacy settings.
- Labeling and Naming: Biosimilars are required to have distinct non-proprietary names (e.g., infliximab-dyyb) to distinguish them from the reference product, although the FDA has a framework for recommending common non-proprietary names.
- Post-Market Surveillance: Biosimilars are subject to post-market surveillance to monitor for any unexpected safety signals.
Market Access Strategies:
- Payer Negotiations: Engaging with payers (insurance companies, PBMs) is paramount. This involves demonstrating the clinical and economic value of the biosimilar to secure favorable formulary placement and reimbursement rates.
- Health Economics and Outcomes Research (HEOR): Robust HEOR data is essential to support value propositions. This includes studies on cost-effectiveness, budget impact analyses, and real-world evidence demonstrating comparable outcomes to the reference product.
- Provider Education and Engagement: Educating physicians, nurses, and pharmacists about the biosimilar's profile, efficacy, safety, and cost-effectiveness is crucial for driving prescribing and uptake.
- Patient Support Programs: Offering patient support programs can help address concerns, improve adherence, and enhance the overall patient experience, mirroring services often provided for the reference product.
- Contracting and Rebates: Manufacturers often utilize contracting and rebate strategies with payers and providers to incentivize the use of their biosimilar product.
- Understanding State Laws: Some states have laws that govern biosimilar substitution. Manufacturers need to be aware of and navigate these varying legal frameworks.
The ability of infliximab-dyyb to achieve interchangeability status, if granted, would significantly streamline its market access and adoption.
What is the Competitive Landscape for Infliximab Biosimilars?
The infliximab market, once solely dominated by Remicade, now features a growing number of biosimilar competitors. This competitive environment directly influences pricing and market share.
Key Competitors and Products:
-
Reference Product:
- Remicade (infliximab) by Janssen Biotech, Inc. (a Johnson & Johnson company)
-
Biosimilars (U.S. Approved):
- Inflectra (infliximab-dyyb) by Pfizer Inc. (marketed by Celltrion Healthcare). This is the biosimilar corresponding to NDC 58284-0264.
- Renflexis (infliximab-abda) by Samsung Bioepis Co., Ltd. and Merck & Co., Inc.
- Avsola (infliximab-axxq) by Amgen Inc.
- Ixifi (infliximab-qfgb) by Viatris Inc. (received tentative approval, subject to additional conditions and exclusivities).
Competitive Dynamics:
- First-Mover Advantage: Inflectra (infliximab-dyyb) was one of the earliest infliximab biosimilars to gain FDA approval in the U.S. (2016), providing an initial advantage in market entry.
- Number of Competitors: The presence of multiple biosimilars (Renflexis, Avsola, etc.) intensifies competition, leading to greater downward pressure on prices.
- Pricing Strategies: Each biosimilar manufacturer employs distinct pricing and contracting strategies to gain market share. These often involve complex negotiations with payers and pharmacy benefit managers.
- Interchangeability Status: The designation of interchangeability for any of these biosimilars would provide a significant competitive edge, allowing for automatic substitution at the pharmacy level.
- Manufacturing and Supply Chain Efficiency: Companies with efficient manufacturing processes and robust supply chains are better positioned to offer competitive pricing and ensure consistent product availability.
- Marketing and Physician Engagement: Successful market penetration relies heavily on effective marketing and engagement with healthcare providers to build confidence and drive prescribing.
The continued increase in the number of approved infliximab biosimilars indicates a mature and competitive market segment.
Key Takeaways
- NDC 58284-0264 represents infliximab-dyyb, a biosimilar to Remicade (infliximab).
- The patent expiries for the original infliximab molecule have allowed for biosimilar market entry, with infliximab-dyyb approved in 2016.
- The infliximab market is substantial, and biosimilars have captured a significant and growing market share due to price competitiveness and payer incentives.
- The introduction of biosimilars has led to considerable price erosion for the reference product and has placed downward pressure on biosimilar pricing.
- Regulatory considerations, particularly interchangeability status, are critical for market access and broader adoption.
- The competitive landscape for infliximab biosimilars is robust, with multiple approved products vying for market share, further driving price reductions.
Frequently Asked Questions
-
What is the difference in cost between Remicade and its biosimilars like NDC 58284-0264? Biosimilars typically launch at a discount of 15-50% compared to the reference biologic, with continued price erosion occurring as competition increases. Specific cost differences vary based on payer contracts and market dynamics.
-
Can NDC 58284-0264 be automatically substituted for Remicade by a pharmacist? Automatic substitution is dependent on whether infliximab-dyyb has been designated as "interchangeable" by the FDA and on state-specific substitution laws. As of current information, interchangeability designations can evolve.
-
Are there any differences in efficacy or safety between Remicade and infliximab-dyyb (NDC 58284-0264)? The FDA requires biosimilars to demonstrate high similarity to the reference product, with no clinically meaningful differences in safety, purity, and potency. Clinical trials and post-market surveillance are used to confirm these equivalencies.
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How many other biosimilars are approved for infliximab in the U.S.? Beyond infliximab-dyyb, the U.S. market has approvals for other infliximab biosimilars such as infliximab-abda, infliximab-axxq, and others, contributing to a competitive environment.
-
What is the projected market growth rate for infliximab biosimilars? The biosimilar market, in general, is projected for significant growth driven by patent expiries, cost containment pressures, and increasing regulatory pathways. The infliximab biosimilar segment is expected to continue this growth trajectory.
Citations
[1] U.S. Food and Drug Administration. (2016, April 5). FDA approves first biosimilar to Remicade. FDA.gov. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-remicade
[2] Global Market Insights. (n.d.). Tumor Necrosis Factor (TNF) Inhibitors Market Size, Share & Industry Analysis. Global Market Insights. https://www.gminsights.com/industry-analysis/tumor-necrosis-factor-tnf-inhibitors-market
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