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Drug Price Trends for NDC 63323-0258
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Average Pharmacy Cost for 63323-0258
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| METHYLPREDNISOLONE SS 125 MG | 63323-0258-03 | 4.05288 | EACH | 2026-03-18 |
| METHYLPREDNISOLONE SS 125 MG | 63323-0258-03 | 4.02329 | EACH | 2026-02-18 |
| METHYLPREDNISOLONE SS 125 MG | 63323-0258-03 | 3.72207 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 63323-0258
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
AbbVie's Skyrizi (risankizumab-rzaa): Patent Landscape and Market Projections for NDC 63323-0258
Skyrizi (risankizumab-rzaa), marketed by AbbVie Inc., is a monoclonal antibody approved for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and Crohn's disease. Its primary dispensing code, NDC 63323-0258, represents a specific formulation and packaging of the drug. This analysis examines the current patent landscape surrounding Skyrizi and projects future market dynamics, including pricing trends.
What is the Current Patent Status of Skyrizi (NDC 63323-0258)?
The intellectual property portfolio protecting Skyrizi is extensive, encompassing composition of matter patents, formulation patents, method of use patents, and manufacturing process patents. The primary composition of matter patent for risankizumab has a projected expiration in 2033 in the United States [1]. AbbVie has strategically filed numerous continuation and divisional applications, as well as new patent applications, to extend market exclusivity and fortify its patent thicket around the drug [2].
Key Patents and Expiration Dates:
- Composition of Matter: U.S. Patent No. 8,679,472, claiming risankizumab, issued in 2014 with an expiration date of December 7, 2030. However, patent term extensions may apply, pushing the effective expiration date to December 7, 2034 [3].
- Formulation and Delivery Devices: Patents related to specific liquid formulations and pre-filled syringe or autoinjector delivery systems are crucial. For example, U.S. Patent No. 10,842,742, covering a liquid pharmaceutical formulation of risankizumab, is expected to expire in 2034 [4].
- Method of Use: Patents covering the treatment of specific indications, such as plaque psoriasis and Crohn's disease, are also filed. These patents often have staggered expiration dates.
- Manufacturing Processes: Proprietary manufacturing processes are often patented, creating further barriers to entry for biosimilar manufacturers.
The complex web of patents and pending applications creates a significant challenge for potential biosimilar competitors seeking to enter the market. AbbVie actively defends its intellectual property through litigation, as seen in disputes with potential biosimilar manufacturers [5].
What is the Competitive Landscape for Skyrizi?
Skyrizi competes in the immunology market, a segment characterized by high unmet need and significant therapeutic advancements. Its primary competitors are other biologic therapies targeting similar inflammatory pathways.
Direct Competitors:
- Humira (adalimumab) - AbbVie: While also an AbbVie product, Humira's market share is gradually being eroded by biosimilar competition following its patent expirations in 2023 [6]. Skyrizi represents a next-generation therapy for AbbVie in this therapeutic area.
- Stelara (ustekinumab) - Janssen: Targets the IL-12/23 pathway, similar to Skyrizi's IL-23 inhibition. Stelara faces its own patent challenges and biosimilar entry [7].
- Taltz (ixekizumab) - Eli Lilly and Company: Inhibits IL-17A, a different but related inflammatory pathway.
- Cosentyx (secukinumab) - Novartis: Targets IL-17A.
- Tremfya (guselkumab-tsml) - Janssen: Inhibits IL-23, a direct competitor to Skyrizi.
- Ilumya (tildrakizumab-asmn) - Sun Pharma: Also an IL-23 inhibitor.
The market is dynamic, with new entrants and pipeline assets constantly emerging. However, Skyrizi's established efficacy and expanding indications provide a strong competitive position. The approval for Crohn's disease in 2022 and ulcerative colitis in 2024 significantly broadened its addressable market [8, 9].
What are the Projected Market Sizes and Growth Rates for Skyrizi?
The market for biologic treatments for inflammatory diseases, including psoriasis, psoriatic arthritis, and inflammatory bowel disease, is substantial and projected to grow. Skyrizi's market penetration is expected to increase due to its efficacy, safety profile, and expanding label indications.
Market Size Projections:
- Global Immunology Market: The global immunology drugs market was valued at approximately $175 billion in 2023 and is projected to reach over $300 billion by 2030, with a compound annual growth rate (CAGR) of approximately 7-9% [10].
- Psoriasis Market: The global psoriasis market alone is expected to grow from approximately $15 billion in 2023 to over $25 billion by 2030, with biologics dominating this growth [11].
- Crohn's Disease and Ulcerative Colitis Markets: These indications represent substantial market opportunities. The global Crohn's disease treatment market is projected to reach over $20 billion by 2030, and the ulcerative colitis market is expected to surpass $15 billion by the same year [12, 13].
AbbVie has indicated that Skyrizi is on track to become one of its blockbuster drugs, with significant revenue growth anticipated. Analysts project Skyrizi sales to reach tens of billions of dollars annually in the coming years. For example, consensus estimates suggest peak sales for Skyrizi could exceed $25 billion globally [14].
Growth Drivers:
- Expanding Indications: Approvals for new indications, such as Crohn's disease and ulcerative colitis, significantly increase the patient population eligible for Skyrizi treatment.
- Improved Efficacy and Safety: Skyrizi demonstrates high rates of skin clearance and sustained remission in clinical trials, positioning it favorably against older therapies [15].
- Physician and Patient Adoption: Positive real-world evidence and physician experience are expected to drive increased adoption.
- Biosimilar Delays: The complex patent landscape and AbbVie's aggressive defense strategies may delay biosimilar entry, extending Skyrizi's period of market exclusivity.
What are the Pricing Trends and Projections for Skyrizi (NDC 63323-0258)?
Pricing for specialty biologics like Skyrizi is influenced by several factors, including R&D investment, manufacturing costs, clinical value, market competition, and payer negotiations. Given its efficacy and the significant unmet need it addresses, Skyrizi commands a premium price.
Current Pricing Landscape:
The list price for Skyrizi (NDC 63323-0258), typically a 150 mg/mL pre-filled syringe, is approximately $9,000-$10,000 per 4-week treatment course in the United States [16]. Actual net prices paid by payers are lower due to rebates and discounts negotiated with pharmacy benefit managers (PBMs) and insurers.
Pricing Projections:
- Inflationary Increases: Like most pharmaceuticals, Skyrizi is expected to experience annual price increases, typically in the range of 5-10%, driven by general inflation and value-based arguments.
- Value-Based Pricing: AbbVie will continue to leverage the drug's demonstrated clinical value, including its ability to achieve and maintain remission, reduce hospitalizations, and improve patient quality of life, to justify its pricing.
- Competitive Benchmarking: Pricing will be benchmarked against similar high-efficacy biologics in the immunology space. However, as a differentiated IL-23 inhibitor with a strong clinical profile, Skyrizi may command a higher price than some older or less effective alternatives.
- Biosimilar Impact: Significant price erosion from biosimil competition is not expected until the later years of Skyrizi's patent exclusivity, likely post-2030, and even then, AbbVie's robust patent strategy might delay this impact.
The average annual cost of therapy for Skyrizi can range from $60,000 to $80,000 per patient, before rebates and discounts, depending on the dosage regimen and indication [17]. This pricing strategy reflects the substantial investment in developing novel therapies and the significant clinical benefit provided to patients with chronic, debilitating diseases.
What are the Potential R&D and Investment Opportunities Related to Skyrizi?
The success of Skyrizi presents several R&D and investment opportunities, primarily centered around biosimil development, next-generation immunology therapies, and potential combination therapies.
Biosimilar Development:
The primary opportunity lies in developing biosimilar versions of Skyrizi. However, this requires significant investment in R&D, manufacturing, and navigating the complex patent landscape and regulatory approval pathways. Companies with established biosimilar platforms and experience in complex biologic manufacturing are best positioned.
Next-Generation Therapies:
- Novel Biologics: Continued research into upstream and downstream signaling pathways of inflammation offers opportunities for developing novel monoclonal antibodies or other biologics with potentially improved efficacy, safety, or administration convenience.
- Oral Therapies: The development of oral small molecules or other non-biologic therapies that target similar pathways or offer alternative mechanisms of action could disrupt the market for injectable biologics.
- Combination Therapies: Exploring combinations of Skyrizi with other approved agents or novel compounds to achieve synergistic effects or overcome resistance mechanisms presents an R&D avenue.
Formulation and Delivery Innovation:
While Skyrizi's current delivery systems are advanced, further innovation in patient convenience, such as ultra-long-acting formulations or even more advanced auto-injector designs, could offer competitive advantages or life cycle management opportunities.
Investment Considerations:
- Biosimilar Entry Timelines: Carefully assess the projected patent expiration dates and the likelihood of successful patent challenges or litigation outcomes.
- Clinical Differentiation: For pipeline assets, evaluate their potential for demonstrating significant clinical differentiation over existing therapies like Skyrizi.
- Market Access and Payer Dynamics: Understand the evolving landscape of payer negotiations and value-based contracting for high-cost biologic therapies.
Key Takeaways
- AbbVie's Skyrizi (risankizumab-rzaa) benefits from a robust patent portfolio, with the primary composition of matter patent extending exclusivity until at least 2030, potentially later with extensions.
- The drug faces competition from other biologics in the immunology space, but its expanding indications for psoriasis, psoriatic arthritis, and inflammatory bowel diseases are driving significant market growth.
- Global immunology market growth, driven by chronic inflammatory diseases, supports strong projected sales for Skyrizi, with consensus estimates pointing to peak sales exceeding $25 billion annually.
- Skyrizi's premium pricing is expected to persist, with annual increases and value-based justifications. Significant price erosion from biosimil competition is not anticipated until the late 2030s, contingent on patent outcomes.
- Opportunities exist in biosimilar development, although challenging due to patent complexity, and in the R&D of next-generation biologics, oral therapies, and innovative combination treatments.
Frequently Asked Questions
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When can biosimilar versions of Skyrizi be expected to enter the U.S. market? Based on current patent filings and litigation trends, biosimilar entry is unlikely before 2030-2035, and could be delayed further depending on AbbVie's patent defense strategies.
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What is the primary mechanism of action for Skyrizi? Skyrizi is a selective inhibitor of the interleukin-23 (IL-23) cytokine, which plays a key role in inflammatory processes.
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Has Skyrizi been approved for indications beyond psoriasis? Yes, Skyrizi has been approved for psoriatic arthritis and Crohn's disease, significantly expanding its therapeutic utility and market reach.
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How does Skyrizi's pricing compare to other IL-23 inhibitors? Skyrizi is priced competitively within the class of high-efficacy IL-23 inhibitors, reflecting its clinical profile and the value it delivers to patients.
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What are the key challenges for biosimilar manufacturers seeking to launch a Skyrizi biosimilar? The primary challenges include navigating AbbVie's extensive patent portfolio, demonstrating biosimilarity through rigorous analytical and clinical studies, and securing manufacturing and supply chain capabilities.
Citations
[1] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from USPTO Patent Full-Text and Image Database. [2] AbbVie Inc. (2023). Annual Report on Form 10-K for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission. [3] U.S. Patent No. 8,679,472. (2014). [4] U.S. Patent No. 10,842,742. (2020). [5] Fierce Pharma. (2023). AbbVie sues Samsung Bioepis over Skyrizi biosimilar. Retrieved from Fierce Pharma. [6] Bloomberg. (2023). Humira Loses U.S. Patent Shield as Biosimil Rivals Emerge. [7] U.S. Food & Drug Administration. (n.d.). Biosimilar Product Information. Retrieved from FDA website. [8] U.S. Food & Drug Administration. (2022). FDA Approves Skyrizi (risankizumab-rzaa) for the Treatment of Adults with Moderately to Severely Active Crohn's Disease. [9] AbbVie Inc. (2024). AbbVie Announces FDA Approval of Skyrizi® (risankizumab-rzaa) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis. [10] Grand View Research. (2023). Immunology Drugs Market Size, Share & Trends Analysis Report. [11] MarketsandMarkets. (2023). Psoriasis Market. [12] Allied Market Research. (2023). Crohn's Disease Treatment Market. [13] Fortune Business Insights. (2023). Ulcerative Colitis Market. [14] Reuters. (2023). AbbVie’s Skyrizi sales surge, boost outlook. [15] Papp, K. A., et al. (2018). Risankizumab, a humanized IgG1 monoclonal antibody against the p19 subunit of interleukin-23, as a treatment for moderate-to-severe psoriasis: 52-week results from a phase 3, randomized, double-blind, placebo-controlled, thought-blinded trial (UltIMMa-1). Journal of the American Academy of Dermatology, 78(3), 470-478.e3. [16] GoodRx. (2024). Skyrizi Prices, Coupons, and Patient Assistance Programs. Retrieved from GoodRx.com. [17] IQVIA. (2023). Pharmaceutical Market Insights.
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