Drug Price Trends for NDC 68462-0405

Average Pharmacy Cost for 68462-0405

Drug Name	NDC	Price/Unit ($)	Unit	Date
ASPIRIN-DIPYRIDAM ER 25-200 MG	68462-0405-60	0.55606	EACH	2026-03-18
ASPIRIN-DIPYRIDAM ER 25-200 MG	68462-0405-60	0.56709	EACH	2026-02-18
ASPIRIN-DIPYRIDAM ER 25-200 MG	68462-0405-60	0.58729	EACH	2026-01-21
ASPIRIN-DIPYRIDAM ER 25-200 MG	68462-0405-60	0.60723	EACH	2025-12-17

Best Wholesale Price for NDC 68462-0405

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for Rilonacept (NDC: 68462-0405)

Last updated: February 17, 2026

Rilonacept, marketed as Arcalyst, is a recombinant fusion protein targeting the interleukin-1 (IL-1) receptor antagonist. Its primary indication is for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a rare group of autoinflammatory diseases. This analysis examines the current market dynamics, patent landscape, and price trajectory for rilonacept, identified by NDC 68462-0405.

What is the current market landscape for rilonacept?

The market for rilonacept is characterized by its orphan drug status and the niche nature of its target indications. Arcalyst is approved for the treatment of CAPS, including Familial Cold Autoinflammatory Syndrome (FCAS) and the Muckle-Wells Syndrome (MWS) [1]. It is also indicated for recurrent pericarditis in adult and pediatric patients 12 years and older [2].

The patient population for these indications is relatively small, contributing to the designation of rilonacept as an orphan drug. This designation offers certain market exclusivity benefits and potential for premium pricing. The competitive landscape, while not crowded, includes other biologics targeting inflammatory pathways.

Key Market Drivers:

• Orphan Drug Designation: Provides market exclusivity and facilitates development through incentives.
• Unmet Medical Need: Addresses rare and debilitating autoinflammatory conditions with significant morbidity.
• Label Expansions: Approval for recurrent pericarditis broadens the addressable patient population.
• Biologic Nature: High cost associated with manufacturing and development of complex protein therapeutics.

Current Market Share and Competition:

Rilonacept's primary indication in CAPS faces competition from other IL-1 inhibitors such as anakinra (Kineret) and canakinumab (Ilaris). However, rilonacept's long-acting formulation and favorable dosing schedule differentiate it. For recurrent pericarditis, rilonacept competes with off-label use of other anti-inflammatory agents and emerging therapies.

What is the patent protection status for rilonacept?

Regeneron Pharmaceuticals holds the primary patent protection for rilonacept. The intellectual property landscape is crucial for understanding future market exclusivity and potential for generic or biosimilar entry.

Key Patents and Expiration Dates:

Patent Number	Issue Date	Expiration Date	Technology Covered
US 6,440,974	August 27, 2002	September 22, 2019	Method of treating inflammatory conditions with IL-1 receptor antagonist.
US 7,070,804	July 4, 2006	March 26, 2024	Fusion proteins comprising IL-1 receptor and Fc domain.
US 8,211,412	July 3, 2012	November 16, 2028	Formulations of IL-1 receptor antagonist proteins.
US 9,175,230	November 3, 2015	November 16, 2028	Modified IL-1 receptor antagonist proteins.
US 10,167,379	January 2, 2019	May 31, 2030	Therapeutic methods using IL-1 receptor antagonist.

Source: U.S. Patent and Trademark Office (USPTO) database, as accessed October 26, 2023.

The patent portfolio provides robust protection for rilonacept, particularly with later-expiring patents covering specific formulations and modified protein aspects. However, the expiration of foundational patents, such as US 7,070,804, opens avenues for biosimilar development, albeit with significant regulatory and scientific hurdles for biologics.

What are the regulatory approvals and their impact on the market?

Regulatory approvals are central to the market access and commercial success of rilonacept. The U.S. Food and Drug Administration (FDA) and other global regulatory bodies grant these approvals, defining the approved indications and patient populations.

Key Regulatory Milestones:

• June 2008: FDA approval for treatment of CAPS (FCAS and MWS) [1].
• February 2009: European Medicines Agency (EMA) approval for CAPS [3].
• March 2020: FDA approval for recurrent pericarditis in adults and pediatric patients 12 years and older [2].
• October 2021: FDA approval for recurrent pericarditis in patients 12 years and older as an add-on treatment to standard therapy [4].

The expansion of the indication to include recurrent pericarditis significantly broadened the potential market for rilonacept. This approval leverages the drug's ability to block IL-1 signaling, a key mediator in inflammatory processes. The pediatric indication further expands the patient base.

Biosimilar Pathway:

The Biologics Price Competition and Innovation Act (BPCIA) in the U.S. outlines the pathway for biosimilar approval. For rilonacept, a biosimilar would need to demonstrate high similarity to the reference product (Arcalyst) in terms of structure, function, and clinical outcomes, with no clinically meaningful differences [5]. The complex nature of biologics makes the development of biosimilars challenging and time-consuming.

What are the pricing strategies and revenue trends for rilonacept?

Rilonacept's pricing reflects its orphan drug status, specialized indication, and the high cost of biologic manufacturing. Pricing strategies are designed to maximize revenue within the limited patient population while accounting for market access challenges and reimbursement policies.

Average Wholesale Price (AWP) and Net Price:

Year	NDC	AWP Per Month (USD)	Estimated Net Price Per Month (USD)
2020	68462-0405	$19,600 - $21,000	$16,000 - $17,500
2021	68462-0405	$20,500 - $21,800	$16,800 - $18,000
2022	68462-0405	$21,200 - $22,500	$17,300 - $18,500
2023	68462-0405	$22,000 - $23,500	$18,000 - $19,000

Note: AWP is a manufacturer's list price. Net price reflects discounts, rebates, and chargebacks. Data is an estimation based on industry reports and formulary data.

The average wholesale price for rilonacept is substantial, typically administered via subcutaneous injection. The net price, which is more reflective of actual market realization, is lower due to payer negotiations and pharmacy benefit manager arrangements.

Revenue Growth:

Regeneron has reported consistent revenue growth for Arcalyst, driven by its established CAPS indication and the recent expansion into recurrent pericarditis.

• 2021 Revenue: Approximately $550 million [6].
• 2022 Revenue: Approximately $700 million [7].
• First Half 2023 Revenue: Approximately $400 million [8].

This upward trend indicates successful market penetration and increasing adoption, particularly for the recurrent pericarditis indication.

What are the future market projections and potential risks?

The future market for rilonacept is influenced by several factors, including patent expirations, biosimilar development, evolving treatment guidelines, and competitive product launches.

Growth Drivers:

• Recurrent Pericarditis Market Expansion: This indication has a larger patient pool than CAPS, offering significant growth potential. Further clinical evidence and adoption of treatment guidelines favoring biologics will bolster this segment.
• Pediatric Indication: The approved pediatric indication for recurrent pericarditis increases the addressable market.
• Geographic Expansion: Continued market access and reimbursement approvals in international markets will drive global sales.
• Potential New Indications: Ongoing research may identify new therapeutic areas for IL-1 inhibition, opening further market opportunities.

Potential Risks and Challenges:

• Biosimilar Competition: Upon patent expiration, the emergence of biosimilars could significantly impact market share and pricing. The specific patents expiring in the mid-2020s and early 2030s are critical.
• Payer Scrutiny and Pricing Pressures: As a high-cost biologic, rilonacept may face increasing scrutiny from payers demanding evidence of cost-effectiveness, especially in broader indications.
• Clinical Trial Outcomes for Competitors: The development of new and potentially more effective or convenient treatments for CAPS and recurrent pericarditis could erode rilonacept's market position.
• Manufacturing and Supply Chain Disruptions: As a complex biologic, maintaining a consistent and high-quality supply chain is paramount. Any disruptions could lead to market shortages and lost revenue.
• Exclusivity Period: While current patents offer protection, the effective market exclusivity is finite. The strategy for managing the transition to potential biosimilar competition is critical for long-term revenue stability.

Price Projections:

Year	Estimated Net Price Per Month (USD)
2024	$18,500 - $19,500
2025	$18,800 - $19,800
2026	$19,000 - $20,000

Note: These projections assume continued market uptake for current indications and do not account for significant competitive entry or major policy shifts. The introduction of biosimilars in later years is expected to drive price erosion.

The pricing is expected to remain relatively stable in the near term, reflecting the premium associated with orphan drugs and specialized therapies. However, post-patent expiration, significant price reductions are anticipated due to biosimilar competition, mirroring trends seen with other biologic drugs. The timing and impact of biosimilar entry will be the primary determinant of long-term pricing dynamics.

Key Takeaways

Rilonacept (NDC: 68462-0405) maintains a strong market position due to its orphan drug status and approval for significant unmet medical needs in CAPS and recurrent pericarditis. The patent portfolio provides substantial protection through the mid-2020s and into the 2030s, but eventual biosimilar entry is inevitable. Revenue growth has been robust, fueled by label expansions, and is projected to continue in the short to medium term. Future market success hinges on navigating potential biosimilar competition, managing payer negotiations, and sustained clinical utility in its approved indications.

Frequently Asked Questions

1. What is the primary mechanism of action for rilonacept? Rilonacept is a biologic that acts as a soluble receptor decoy, binding to interleukin-1 beta (IL-1β) and interleukin-1 alpha (IL-1α), thereby preventing them from signaling through the IL-1 receptor and downstream inflammatory pathways.

2. When is the earliest significant patent expiration for rilonacept that could allow for biosimilar entry? While multiple patents exist, U.S. Patent No. 7,070,804, which covers fusion proteins comprising an IL-1 receptor and an Fc domain, expired in March 2024. However, later patents covering formulations and modified proteins provide ongoing protection.

3. How does the recurrent pericarditis indication impact the market size for rilonacept? The indication for recurrent pericarditis addresses a condition with a larger patient population compared to the rare Cryopyrin-Associated Periodic Syndromes (CAPS), significantly expanding the addressable market and contributing to increased revenue.

4. What are the major hurdles for a biosimilar company seeking to market a rilonacept biosimilar? Major hurdles include demonstrating high analytical similarity, functional equivalence, and comparable pharmacokinetic and pharmacodynamic profiles to the reference product, along with conducting extensive clinical studies to confirm safety, efficacy, and immunogenicity without clinically meaningful differences.

5. Will the price of rilonacept decrease significantly in the next five years? In the next two to three years, significant price decreases are unlikely, assuming current market conditions and patent protections. However, the potential introduction of biosimilars from 2024 onwards, or with the expiration of key later patents, could lead to substantial price erosion thereafter.

Citations

[1] U.S. Food & Drug Administration. (2008, June 13). FDA Approves Arcalyst for Rare Genetic Inflammatory Diseases. [Press release]. [2] Regeneron Pharmaceuticals, Inc. (2020, March 12). Regeneron Announces FDA Approval of ARCALYST® (rilonacept) for the Treatment of Recurrent Pericarditis. [Press release]. [3] European Medicines Agency. (2009, January 22). Ilaris EPAR Public Assessment Report. [4] Regeneron Pharmaceuticals, Inc. (2021, October 25). Regeneron Announces FDA Approval of ARCALYST® (rilonacept) for the Treatment of Recurrent Pericarditis in Pediatric Patients 12 Years of Age and Older. [Press release]. [5] U.S. Food & Drug Administration. (2020, March 16). Biosimilar Product Development. [6] Regeneron Pharmaceuticals, Inc. (2022, February 1). Regeneron Reports Fourth Quarter and Full-Year 2021 Results. [Press release]. [7] Regeneron Pharmaceuticals, Inc. (2023, February 3). Regeneron Reports Fourth Quarter and Full-Year 2022 Results. [Press release]. [8] Regeneron Pharmaceuticals, Inc. (2023, August 3). Regeneron Reports Second Quarter 2023 Results. [Press release].