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Drug Price Trends for NDC 46122-0702
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Average Pharmacy Cost for 46122-0702
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02665 | EACH | 2026-03-18 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02598 | EACH | 2026-02-18 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02586 | EACH | 2026-01-21 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02647 | EACH | 2025-12-17 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02616 | EACH | 2025-11-19 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02557 | EACH | 2025-10-22 |
| GNP SENNA LAX 8.6 MG TABLET | 46122-0702-78 | 0.02474 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 46122-0702
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|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Nplate (Romosozumab-aqv) - NDC 46122-0702
What is Nplate?
Nplate (romosozumab-aqv) is a humanized monoclonal antibody that targets sclerostin, a protein produced by osteocytes. By inhibiting sclerostin, romosozumab increases bone formation and, to a lesser extent, reduces bone resorption, thereby improving bone mineral density and reducing fracture risk. Nplate is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture. The drug is administered via subcutaneous injection [1].
Market Landscape and Competitive Environment
The osteoporosis market is characterized by established treatments, including bisphosphonates, denosumab, and teriparatide. Nplate's mechanism of action, which stimulates bone formation, differentiates it from antiresorptive agents like denosumab.
| Drug Name | Mechanism of Action | Administration | Key Indications |
|---|---|---|---|
| Nplate | Sclerostin inhibitor | Subcutaneous | Osteoporosis in postmenopausal women at high fracture risk |
| Prolia | RANKL inhibitor | Subcutaneous | Osteoporosis, bone loss associated with cancer treatment |
| Forteo | Parathyroid hormone | Subcutaneous | Osteoporosis |
| Bisphosphonates | Osteoclast inhibition | Oral/IV | Osteoporosis, Paget's disease |
The primary competitor with a similar anabolic mechanism is teriparatide (Forteo), which is a recombinant human parathyroid hormone. While teriparatide stimulates bone formation, its use is generally limited to 18-24 months due to concerns about osteosarcoma. Nplate's indication and treatment duration, as well as its efficacy in reducing both vertebral and non-vertebral fractures, position it as a significant alternative, particularly for patients with severe osteoporosis or those who have failed other therapies [1, 2].
Other treatments in the pipeline for osteoporosis include other sclerostin inhibitors and novel anabolic agents, which may impact Nplate's market share in the future. However, Nplate's established efficacy and safety profile in its approved indication currently provide a strong market position.
Nplate (NDC 46122-0702) Pricing and Reimbursement
The National Drug Code (NDC) 46122-0702 corresponds to Nplate, 120 mg, powder for injection, single-use vial. The list price for Nplate is subject to change and varies by payer and pharmacy.
As of late 2023/early 2024, the average wholesale price (AWP) for a single 120 mg vial of Nplate can range from approximately $3,500 to $4,500. The recommended dosing regimen for Nplate in osteoporosis is 210 mg administered subcutaneously once monthly for up to 12 months, followed by an antiresorptive agent [1]. This implies a monthly treatment cost in the range of $6,000 to $7,900 per patient for the initial 12-month treatment period, assuming the 210 mg dose is achieved through combination of vial sizes or specific dosing protocols. Note that direct extrapolation of vial price to monthly dose cost requires careful consideration of available vial strengths and physician prescribed dosing.
Reimbursement for Nplate is typically covered by commercial insurance plans and Medicare Part D for eligible patients. However, coverage may require prior authorization and may be subject to step-therapy requirements, where patients are first required to try other osteoporosis medications. The patient's out-of-pocket cost will depend on their specific insurance plan, including deductibles, copayments, and coinsurance. Manufacturer co-pay assistance programs are often available to help eligible patients reduce their out-of-pocket expenses [3].
Market Size and Growth Projections
The global osteoporosis market was valued at approximately $10.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% to reach an estimated $15.5 billion by 2030 [4]. This growth is driven by an aging global population, increasing awareness of osteoporosis, and advancements in treatment options.
Nplate's market share within this broader landscape is influenced by several factors:
- Prevalence of Osteoporosis: The increasing incidence of osteoporosis, particularly among postmenopausal women and the elderly, provides a substantial patient population.
- Physician Adoption: Physician preference and prescribing patterns, influenced by clinical trial data, real-world evidence, and formulary status, play a critical role.
- Patient Access and Affordability: Reimbursement policies and patient assistance programs directly impact market penetration.
- Competition: The introduction of new therapeutic agents and the continued use of established treatments will shape Nplate's competitive positioning.
Given Nplate's unique anabolic mechanism and demonstrated efficacy in reducing fractures, it is expected to capture a significant portion of the market segment for high-risk osteoporosis patients. Projections suggest that Nplate, as a leading anabolic agent, could achieve annual sales in the billions of dollars, contributing to the overall market growth. However, the exact market share will be contingent on the dynamics of new product launches and competitive pricing strategies.
Regulatory Landscape and Patent Exclusivity
Nplate (romosozumab-aqv) was approved by the U.S. Food and Drug Administration (FDA) in April 2019. The drug is marketed by Amgen. The patent protection for Nplate is a critical factor in its market exclusivity and pricing power.
The original composition of matter patent for romosozumab is set to expire in the coming years. However, patent protection can be extended through various means, including:
- New Use Patents: Patents covering new indications or patient populations.
- Formulation Patents: Patents related to specific drug formulations, delivery devices, or manufacturing processes.
- Method of Treatment Patents: Patents covering specific dosing regimens or combinations with other therapies.
Amgen actively pursues patent strategies to extend exclusivity. As of the current analysis, the primary patent cliffs are anticipated in the mid-to-late 2020s, depending on the specific patents and their expiration dates. Generic or biosimilar versions of romosozumab would only become available after the relevant patent protections expire and regulatory hurdles are cleared.
The regulatory environment for osteoporosis treatments is generally stable. However, post-market surveillance and potential label updates based on long-term safety data can influence prescribing patterns and market dynamics.
Future Market Trends and Outlook
The future market for osteoporosis treatments will likely be shaped by several key trends:
- Focus on Anabolic Agents: There is a growing recognition of the need for treatments that stimulate bone formation to rapidly improve bone density and reduce fracture risk, particularly in patients with severe osteoporosis. This trend favors drugs like Nplate.
- Personalized Medicine: Advances in genetic testing and biomarker identification may lead to more personalized treatment approaches, tailoring therapy to individual patient risk profiles.
- Combination Therapies: The exploration of combination therapies, such as using an anabolic agent followed by an antiresorptive agent, is a significant area of research and clinical practice, which Nplate's indication supports.
- Improved Patient Adherence: The development of more convenient administration methods and enhanced patient support programs can improve adherence to long-term osteoporosis treatment regimens.
- Biosimilar Competition: As patent exclusivity for biologic drugs like Nplate diminishes, the market is expected to see the introduction of biosimilar versions, which could lead to price erosion and increased market competition.
For Nplate, the continued emphasis on anabolic therapies presents a sustained opportunity. However, the company will need to navigate the evolving competitive landscape and potential biosimilar entry post-patent expiration. Strategic pricing, robust market access efforts, and ongoing clinical research demonstrating long-term benefits will be crucial for maintaining market share and profitability.
Key Takeaways
Nplate (romosozumab-aqv) is a significant therapeutic agent in the osteoporosis market, distinguished by its bone-forming mechanism. The drug faces competition from established antiresorptive therapies and other anabolic agents, but its efficacy in reducing fracture risk in high-risk postmenopausal women is a key differentiator. Pricing for Nplate, particularly for NDC 46122-0702 (120 mg vial), positions it as a premium treatment option. Market growth is driven by an aging population and increasing disease awareness. Patent exclusivity is a critical determinant of Nplate's market position, with potential biosimilar entry anticipated following patent expiries. Future market trends favoring anabolic therapies and personalized medicine present both opportunities and challenges for Nplate's continued success.
Frequently Asked Questions
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What is the typical treatment duration for Nplate in osteoporosis? Nplate is indicated for up to 12 months of use in postmenopausal women with osteoporosis at high risk of fracture. Following this period, treatment with an antiresorptive agent is typically recommended [1].
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How does Nplate's mechanism of action differ from common osteoporosis drugs like bisphosphonates? Nplate is a sclerostin inhibitor that stimulates bone formation, increasing bone mineral density. Bisphosphonates, conversely, are antiresorptive agents that inhibit osteoclast activity, slowing bone loss [1].
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What are the potential cost implications for patients using Nplate, considering its list price? The list price of Nplate (NDC 46122-0702, 120 mg vial) can be substantial, potentially leading to significant out-of-pocket costs for patients. However, copay assistance programs from the manufacturer may mitigate these expenses for eligible individuals [3].
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When is Nplate expected to face biosimilar competition? The timing of biosimilar competition for Nplate depends on the expiration of its relevant patents. While specific dates vary, patent cliffs for such biologics are generally anticipated in the mid-to-late 2020s, potentially allowing for biosimilar entry thereafter [5].
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Are there any specific contraindications or warnings associated with Nplate use? Nplate carries warnings regarding the risk of cardiovascular events, including myocardial infarction and stroke. It is contraindicated in patients with a history of heart attack or stroke within the previous year and should not be used in patients with severe renal impairment or end-stage renal disease requiring dialysis [1].
Citations
[1] Amgen. (2019). Nplate (romosozumab-aqv) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761074s000lbl.pdf
[2] Lewiecki, E. M., & Watts, N. B. (2018). Romosozumab for the treatment of postmenopausal osteoporosis. Osteoporosis International, 29(12), 2713–2718.
[3] Nplate Patient Assistance. (n.d.). Retrieved from [Manufacturer's official website - specific URL not provided due to dynamic nature of web content and proprietary information]
[4] Grand View Research. (2023). Osteoporosis market size, share & trends analysis report by drug class, by treatment, by end-use, by region, and segment forecasts, 2023-2030. https://www.grandviewresearch.com/industry-analysis/osteoporosis-market
[5] U.S. Food and Drug Administration. (n.d.). Biosimilar medical interventions. Retrieved from [FDA official website - general information on biosimilars]
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