Share This Page
Drug Price Trends for NDC 00054-0254
✉ Email this page to a colleague
Average Pharmacy Cost for 00054-0254
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00054-0254
| 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 NDC 00054-0254
Introduction
This report provides a comprehensive market analysis and future price projection for the drug associated with the National Drug Code (NDC) 00054-0254. As a professional drug patent analyst, the focus is on understanding the product's therapeutic profile, current market landscape, patent status, competitive dynamics, regulatory environment, manufacturing considerations, and pricing trends. The goal is to equip pharmaceutical stakeholders, investors, and healthcare providers with strategic insights for informed decision-making.
Product Profile and Therapeutic Indication
The NDC 00054-0254 corresponds to Abaloparatide Injection, marketed primarily for postmenopausal women with osteoporosis at high risk for fracture. Approved by the U.S. Food and Drug Administration (FDA) in 2017, Abaloparatide is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP), designed to stimulate osteoblastic activity and enhance bone density.
This drug fills a critical niche within the osteoporosis treatment landscape, particularly targeting high-risk populations who require anabolic therapy over anti-resorptive options like bisphosphonates. Its innovative mechanism of action offers an alternative for patients intolerant to traditional therapies.
Current Market Landscape
Market Size and Demand Dynamics
The global osteoporosis market was valued at approximately $13 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2028 [1]. In the U.S., the postmenopausal osteoporosis segment dominates, driven by an aging population.
Abaloparatide's role in this niche is substantial but limited by factors such as:
- Market penetration: As a newer entrant, its adoption remains constrained by cost, clinician familiarity, and competition.
- Patient eligibility: It's prescribed primarily for patients with a high fracture risk, limiting its universal applicability.
- Preference for anabolic therapies: Growing interest in anabolic agents like Teriparatide and Romosozumab influences market share dynamics.
Competitive Landscape
Major competitors include:
- Teriparatide (Forteo) by Eli Lilly – the first FDA-approved anabolic agent for osteoporosis.
- Romosozumab (Evenity) by Amgen – a monoclonal antibody with dual mechanisms (anabolic and anti-resorptive).
- Bisphosphonates (e.g., Alendronate, Risedronate) – first-line, cost-effective options.
While Abaloparatide offers similar anabolic benefits, its market share remains modest, influenced by:
- Pricing strategies
- Physician prescribing habits
- Patient preferences
Patent and Regulatory Status
Patent Protection
Abaloparatide was developed by Radius Health, with initial patents expiring around 2027–2028, depending on jurisdiction and patent extensions. Patent expirations could lead to generic competition, impacting pricing and market share.
Regulatory Milestones
FDA approval in 2017 secured early market access. Labeling emphasizes its use in high-risk postmenopausal women, with security on safety profiles for up to 24 months of treatment [2].
Continued regulatory adherence and post-marketing surveillance ensure competitive longevity, but patent expirations threaten future exclusivity.
Manufacturing and Supply Chain Considerations
Abaloparatide is synthesized via recombinant DNA technology, requiring specialized biopharmaceutical manufacturing facilities adhering to Good Manufacturing Practices (GMP). Supply chain stability is crucial; factors such as raw material costs, manufacturing capacity, and potential biosimilar entrants influence pricing.
Recent advancements in peptide synthesis and scale-up technologies reduce production costs marginally, but high-quality standards maintain overall pricing levels.
Pricing Trends and Projections
Current Pricing Metrics
- Average wholesale price (AWP): Approximately $5,700 per month (varies by location and payer negotiations) [3].
- Patient out-of-pocket costs: Often significantly higher, depending on insurance coverage, prior authorizations, and co-payment structures.
Factors Influencing Future Price Trajectory
- Patent expiration and biosimilar entry: Likely to introduce price competition, exerting downward pressure starting around 2027.
- Market competition: Adoption rates of Romosozumab and Teriparatide influence demand and pricing.
- Reimbursement policies: Value-based pricing models and formulary decisions impact net revenue.
- Manufacturing efficiencies: Improved production processes may lower costs, potentially enabling price reductions or better margins.
- Regulatory landscape: Additional indications or biosimilar approvals could further influence pricing.
Price Projection Outlook (2023–2030)
| Year | Estimated Price Range (per month) | Key Factors |
|---|---|---|
| 2023 | $5,700 – $6,000 | Stabilized; high demand among high-risk patients; ongoing payer negotiations |
| 2024 | $5,500 – $6,000 | Slight competitive pressure from alternative therapies |
| 2025 | $5,300 – $5,800 | Increased adoption of biosimilars anticipated |
| 2026 | $4,800 – $5,500 | Pre-patent-expiry market stabilization |
| 2027 | $3,500 – $5,000 | Patent expiry; biosimilar entry begins |
| 2028 | $2,500 – $4,500 | Increased biosimilar competition; market stabilization |
| 2029–2030 | $2,000 – $4,000 | Significant biosimilar penetration; formulary shifts |
Note: The projected prices account for typical drug depreciation patterns, market penetration by biosimilars, and evolving payer strategies.
Strategic Implications
- Patent Protection Management: Maintaining patent exclusivity through legal tactics and formulation improvements can buffer early price erosion.
- Market Expansion: Pursuing additional indications or population subsets (e.g., men with osteoporosis) could extend market lifespan.
- Pricing Strategies: Employing value-based pricing and patient assistance programs can sustain revenue amid increasing biosimilar options.
- Collaborative Approaches: Partnering with payers and healthcare providers to demonstrate clinical value and cost-effectiveness ensures better market positioning.
Key Takeaways
- NDC 00054-0254 (Abaloparatide) holds a significant, though niche, position in the osteoporosis therapeutics market, driven by its anabolic mechanism and targeted patient population.
- Market growth is expected to continue modestly, influenced by demographic trends and rising awareness.
- Patent expiration around 2027 will likely trigger biosimilar competition, exerting downward pressure on prices.
- Current pricing remains high, with projections showing a gradual decline to approximately $2,000–$4,000/month by 2030 due to biosimilar market entry.
- Strategic patent and market management, along with adoption of cost-effective competition, will determine profitability and market share in the coming years.
FAQs
Q1: When is the patent for Abaloparatide set to expire, and how will it affect pricing?
A1: The patent expires around 2027–2028. Post-expiry, biosimilar competition is expected, leading to significant price reductions.
Q2: What are the main competitors to Abaloparatide in the osteoporosis market?
A2: Key competitors include Teriparatide (Forteo), Romosozumab (Evenity), and traditional bisphosphonates.
Q3: How does the cost of Abaloparatide impact its adoption?
A3: High monthly costs ($5,700 on average) limit access primarily to high-risk patients covered by insurance or assistance programs; cost-effectiveness plays a vital role in prescribing patterns.
Q4: What strategies can manufacturers deploy to maintain profitability as biosimilars enter the market?
A4: Focus on patent extension strategies, expand indications, enhance manufacturing efficiency, and negotiate value-based reimbursement deals.
Q5: How is the market for osteoporosis treatments expected to evolve through 2030?
A5: Growth will be driven by demographic aging, enhanced therapeutic options, and increasing awareness, balanced by biosimilar competition and value-based pricing adjustments.
References
- MarketsandMarkets. Osteoporosis Drugs Market by Therapy, Region – Global Forecast to 2028.
- FDA. Abaloparatide (Tymlos) Prescribing Information. 2017.
- GoodRx. Abaloparatide (Tymlos) Cost and Pricing Data, 2023.
Disclaimer: This analysis synthesizes publicly available information and expert projections. Actual market dynamics may vary.
More… ↓
