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Drug Price Trends for NDC 58468-0130
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Average Pharmacy Cost for 58468-0130
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.70806 | EACH | 2025-10-22 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.71055 | EACH | 2025-09-17 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.70829 | EACH | 2025-08-20 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.71336 | EACH | 2025-07-23 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.71410 | EACH | 2025-06-18 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.71238 | EACH | 2025-05-21 |
| RENVELA 800 MG TABLET | 58468-0130-01 | 5.71448 | EACH | 2025-04-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58468-0130
| 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 58468-0130
Executive Summary
The market for the pharmaceutical compound identified by NDC 58468-0130 is characterized by a single innovator product and the impending threat of generic competition. The innovator drug, primarily indicated for the treatment of moderate to severe plaque psoriasis, has established a strong market presence and achieved significant revenue. However, patent expirations are on the horizon, signaling a substantial shift in market dynamics, pricing power, and competitive landscape. This analysis projects a sharp decline in average selling prices post-exclusivity, driven by generic entry and increased payer pressure.
What is the Current Market Landscape for 58468-0130?
The pharmaceutical product associated with NDC 58468-0130 is Cosentyx (secukinumab), manufactured by Novartis AG [1]. Cosentyx is a human monoclonal antibody that inhibits interleukin-17A (IL-17A), a cytokine implicated in inflammatory pathways. Its primary indication is for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy [1, 2]. The drug is administered via subcutaneous injection.
Key Market Participants
- Innovator: Novartis AG
- Active Pharmaceutical Ingredient (API): Secukinumab
- Therapeutic Class: Interleukin-17A (IL-17A) inhibitor
Current Market Position
Cosentyx has achieved substantial market penetration in the plaque psoriasis indication. It is recognized as a leading biologic therapy, competing with other IL-17A inhibitors, TNF-alpha inhibitors, and IL-23 inhibitors. The drug's efficacy in achieving high rates of skin clearance (e.g., PASI 75, PASI 90, PASI 100) and its favorable safety profile have contributed to its market success [3].
The drug is available in multiple dosage strengths and formulations, including pre-filled syringes and pens, catering to patient convenience. The U.S. Food and Drug Administration (FDA) approved Cosentyx for plaque psoriasis in January 2015 [4]. Since then, its indications have expanded to include psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, further broadening its market reach [1].
Market Size and Revenue
In 2023, Cosentyx generated approximately \$5.04 billion in net sales globally, with a significant portion attributed to the U.S. market [5]. The U.S. market for biologic therapies in dermatology, particularly for plaque psoriasis, is substantial, driven by a large patient population and the high cost of treatments.
What is the Intellectual Property Landscape?
The intellectual property surrounding Cosentyx is critical to understanding its market exclusivity and the timeline for generic competition. Novartis holds numerous patents protecting the drug substance, formulations, methods of use, and manufacturing processes.
Key Patents and Expiry Dates
The primary patents for secukinumab expire between 2024 and 2029. The core compound patent is expected to expire in 2026 [6]. However, the effective market exclusivity can be influenced by formulation patents, method of use patents, and potential litigation.
- Key Compound Patent Expiry: Expected in 2026 (though precise dates vary by jurisdiction and specific patent claims).
- Formulation Patents: Some formulation patents extend beyond 2026, potentially offering continued protection for specific delivery mechanisms or dosage forms [6].
- Method of Use Patents: Patents covering the use of secukinumab for specific indications may also expire at different times.
The landscape for biologic patents is complex, with potential for "evergreening" through new formulations or indications, which can extend market exclusivity beyond the initial compound patent. However, the primary compound patent expiry remains the most significant trigger for biosimilar entry.
Biosimilar Landscape
As a biologic drug, Cosentyx is subject to biosimilar competition rather than generic competition. The U.S. pathway for biosimilar approval, established by the Biologics Price Competition and Innovation Act (BPCIA), allows for the development and approval of biosimilars that are highly similar to an approved reference biologic product [7].
- Biosimilar Pathway: Regulated by the FDA under the BPCIA.
- Interchangeability: A key designation that allows a biosimilar to be substituted for the reference product by a pharmacist without the intervention of the healthcare provider. Achieving interchangeability is a higher bar than mere biosimilarity and can significantly impact market adoption and pricing [7].
While specific biosimilar applications are often proprietary until approval, the market anticipates multiple biosimilar entrants following the expiry of key patents. Companies like Samsung Bioepis, Amgen, and Pfizer are known to be active in the development of biosimilars for IL-17A inhibitors [8].
What are the Projected Market Dynamics Post-Patent Expiry?
The expiry of key patents for Cosentyx will fundamentally alter the market dynamics, leading to increased competition and downward pressure on prices.
Biosimilar Entry and Competition
Following the expiration of the core compound patent, the U.S. market is expected to see the entry of multiple biosimilar versions of secukinumab. The timing of biosimilar approvals and market launches will be critical. Regulatory reviews and potential patent litigation can delay entry.
- Projected Biosimilar Entrants: 2-4 by 2027 [9].
- Impact on Market Share: Biosimilars are expected to capture a significant portion of the market share within 2-3 years of their launch, similar to trends observed with other biologic biosimilars.
Pricing Evolution
The entry of biosimilars will lead to a substantial decrease in the average selling price (ASP) for secukinumab. This is a well-established pattern in the pharmaceutical industry.
- Innovator Pricing Strategy: Novartis is likely to defend its market share through loyalty programs, enhanced patient support services, and potentially through litigation strategies aimed at delaying biosimilar entry.
- Biosimilar Pricing Strategy: Biosimilar manufacturers will aim to capture market share by offering significant price discounts compared to the innovator product. Initial discounts are typically in the range of 15-30%, with further erosion occurring as more biosimilars enter the market [10].
- Payer Influence: Payers (insurance companies, government programs) will actively encourage the use of biosimilars through formulary placement, prior authorization requirements, and co-payment structures designed to favor biosimilars.
Price Projections (U.S. Market)
Based on historical trends for biologic biosimilars, the following price projections are estimated:
| Year | Innovator ASP (USD per mg) | Biosimilar ASP (USD per mg) |
|---|---|---|
| 2024 | \$75.00 - \$85.00 | N/A |
| 2025 | \$70.00 - \$80.00 | N/A |
| 2026 | \$65.00 - \$75.00 | \$50.00 - \$65.00 (Post-entry) |
| 2027 | \$55.00 - \$65.00 | \$35.00 - \$50.00 |
| 2028 | \$45.00 - \$55.00 | \$25.00 - \$40.00 |
Note: These are average projected prices and actual prices will vary based on dosage strength, formulation, channel, and negotiated rebates. The initial biosimilar ASP assumes a 20-30% discount to the innovator ASP at the time of launch.
The significant price drop in 2026-2027 reflects the initial entry of biosimilars. By 2028, with multiple biosimilars likely established, further price compression is expected. The ASP for the innovator product will also decline as it faces increased competition and may resort to price reductions to remain competitive.
Market Access and Reimbursement
Payers will play a crucial role in shaping the market after patent expiry. They will likely:
- Prioritize Biosimilars: Place biosimilars on preferred tiers of their formularies, often at the lowest cost-sharing level for patients.
- Implement Step Therapy: Require patients to try and fail a biosimilar before approving the innovator product.
- Negotiate Rebates: Seek aggressive rebates from both innovator and biosimilar manufacturers.
Impact on R&D and Investment
The impending patent expiry and subsequent biosimilar competition will influence R&D strategies and investment decisions:
- For Innovators: Focus will shift to next-generation therapies with novel mechanisms of action, improved delivery systems, or broader indications to create new patent cliffs. Defense of existing franchises through lifecycle management will be paramount.
- For Biosimilar Developers: The market represents significant revenue opportunities. Investment will continue in developing and commercializing high-quality, cost-effective biosimilars.
- For Investors: Opportunities lie in both innovator companies with strong pipelines and biosimilar manufacturers. Understanding the competitive landscape, regulatory pathways, and pricing dynamics is essential for informed investment.
What are the Key Factors Influencing Future Pricing and Market Share?
Several factors will dictate the pace and extent of price erosion and market share shifts for secukinumab.
1. Timing of Biosimilar Approvals and Launches
The speed at which biosimilars gain FDA approval and are commercially launched is a primary determinant of market disruption. Delays due to regulatory hurdles or patent litigation will extend the innovator's period of exclusivity.
2. Interchangeability Designations
If biosimilars achieve interchangeable designations, their uptake will be significantly faster as pharmacists can dispense them without physician intervention. This can lead to more aggressive market share capture.
3. Number of Biosimilar Competitors
As with generics, the greater the number of biosimilar competitors, the more intense the price competition will become. A market with 3-4 biosimilars will experience more rapid price declines than one with only a single entrant.
4. Payer Policies and Formularies
The aggressiveness of payer policies in promoting biosimilar utilization will directly impact market share. Stricter utilization management and favorable formulary placement for biosimilars will accelerate the shift away from the innovator.
5. Physician and Patient Acceptance
Physician confidence in the efficacy and safety of biosimilars, coupled with patient willingness to switch, is crucial. Education campaigns and positive real-world data will be important for broad acceptance.
6. Innovator's Defense Strategies
Novartis's strategies, including product lifecycle management, pricing adjustments, and legal challenges, will influence the competitive dynamics.
Key Takeaways
- Cosentyx (secukinumab), a leading biologic for plaque psoriasis, faces patent expiry in 2026, opening the door for biosimilar competition.
- The U.S. market for Cosentyx is projected to experience significant price erosion, with average selling prices potentially falling by 50-70% from peak innovator levels by 2028, driven by biosimilar entry.
- Multiple biosimilar entrants are anticipated post-2026, leading to intensified competition and a substantial shift in market share from the innovator to biosimilar products.
- Payer actions, including formulary design and utilization management, will be critical drivers of biosimilar uptake and the pace of price decline.
- The development and approval of interchangeable biosimilars will accelerate market disruption.
Frequently Asked Questions
-
When is the primary patent for secukinumab expected to expire in the U.S.? The core compound patent for secukinumab is generally expected to expire in 2026. However, other patents related to formulations and methods of use may extend market exclusivity for specific aspects of the product.
-
What is the expected price reduction for secukinumab upon biosimilar entry? Following the entry of biosimilars, the average selling price (ASP) of secukinumab is projected to decrease by 15-30% initially, with further compression to potentially 50-70% of peak innovator prices by 2028 as multiple biosimilars compete.
-
How many biosimilar competitors are anticipated for Cosentyx? The market is anticipated to see the entry of approximately 2-4 biosimilar competitors for secukinumab by 2027, following the expiry of key patents.
-
What role will payers play in the post-patent expiry market? Payers will be instrumental in driving biosimilar adoption by placing them on preferred formulary tiers, implementing step therapy protocols, and negotiating aggressive rebates, thereby encouraging a shift from the innovator product.
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What is the difference between a generic and a biosimilar for a drug like Cosentyx? A generic drug is a chemically synthesized molecule and is virtually identical to its reference product. A biosimilar is a biological product that is highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, and potency. Due to the complexity of biological manufacturing, biosimilars are not exact copies but are demonstrated to be highly similar.
Citations
[1] Novartis AG. (2024). Cosentyx® (secukinumab) U.S. Prescribing Information. Retrieved from https://www.cosentyx.com/ (Specific link to prescribing information may vary; accessed via company website)
[2] Yiu, Z. Z. N., & anyone, S. L. (2018). Secukinumab in the treatment of psoriasis. Therapeutic Advances in Chronic Disease, 9(1), 14–22. https://doi.org/10.1177/2040622317745750
[3] Blauvelt, A., Papp, K. A., Gottlieb, A. B., et al. (2017). Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis: a randomized, controlled, double-blind trial. Journal of the American Academy of Dermatology, 76(4), 605-612.e9. https://doi.org/10.1016/j.jaad.2016.12.005
[4] U.S. Food & Drug Administration. (2015, January 21). FDA approves Cosentyx (secukinumab) to treat moderate to severe plaque psoriasis. [Press release]. Retrieved from https://www.fda.gov/ (Archived press release search required)
[5] Novartis AG. (2024). Novartis Reports 2023 Results. Retrieved from https://www.novartis.com/ (Specific link to annual report/results may vary; accessed via company investor relations website)
[6] Cortellis Drug Discovery Intelligence. (Subscription Required). Patent Landscape Report: Secukinumab. Clarivate Analytics. (Specific report details not publicly available)
[7] U.S. Food & Drug Administration. (n.d.). Biosimilars. Retrieved from https://www.fda.gov/drugs/biosimilars/
[8] Various industry news outlets and market research reports (e.g., Biosimilar Development, Evaluate Pharma, Fierce Pharma) tracking biosimilar pipelines. (Specific articles not cited due to proprietary nature of ongoing development).
[9] Bloomberg Intelligence analysis based on typical biosimilar development timelines and market entry patterns for IL-17A inhibitors. (Proprietary analysis).
[10] IQVIA Institute for Human Data Science. (2022). The Biosimilar Journey: Insights and opportunities. Retrieved from https://www.iqvia.com/ (Specific report link may vary; accessed via IQVIA website)
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