Last updated: February 24, 2026
What is the drug associated with NDC 42291-0779?
The National Drug Code (NDC) 42291-0779 corresponds to Abaloparatide-SC injection (brand name Tymlos). It is approved by the FDA for treating postmenopausal women with osteoporosis at high fracture risk.
Market Overview
Market Size
The global osteoporosis treatment market was valued at approximately $10 billion in 2022. North America accounts for roughly 45% of this market, with the U.S. generating close to $4.5 billion.
Key Competitors
- Teriparatide (Forteo): Market leader; 30% share.
- Denosumab (Prolia): 25% share.
- Romosozumab (Evenity): 20% share.
- Romosozumab (Evenity): 20% share.
- Abaloparatide (Tymlos): 8% to 10% share.
Prescriber and Patient Trends
The aging population fuels demand. Estimated 20 million osteoporotic women aged 50+ in the U.S. alone. Around 600,000 initiated osteoporosis treatment annually, with growth driven by increased diagnosis and awareness.
Reimbursement Landscape
Coverage for Tymlos varies, with private payers covering approximately 80% of prescriptions. Medicare reimbursement policies favor high-efficacy treatments, influencing market penetration.
Sales and Revenue Trends
Historical Sales Data
- 2020: $200 million
- 2021: $250 million
- 2022: $270 million
Post-approval of new formulations or indications could increase revenue by 10-15% annually.
Distribution Channels
Primarily via specialty pharmacies and hospital outpatient clinics. Patient access exhibits geographic variability.
Price Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately $3,200 per month (per 106 mcg dose).
- Average Selling Price (ASP): Estimated at $2,500 per month, factoring discounts and rebates.
Future Price Trends (Next 5 Years)
- Price stabilization expected due to competition from biosimilars.
- Potential reductions: 5-10%, driven by patent expiration and market entry of biosimilars.
- Market share growth: As physicians favor treatments with fewer administration considerations, Tymlos could increase utilization.
Impact of Biosimilar Entry
Biosimilars historically reduce branded drug prices by 15-30%. For osteoporotic agents, biosimilars are expected around 2025, thus impacting Tymlos’s pricing and market share.
Price Sensitivity
Patients with commercial insurance may face co-pays of $50-$200 per month, while uninsured or underinsured patients may encounter prices exceeding $2,800 monthly, limiting access.
Policy and Regulatory Influences
- FDA policies: Encourage biosimilar development which could lead to price declines.
- Insurance formularies: Favor high-efficacy but more cost-effective options, potentially reducing Tymlos’s market share.
Summary of Projections (Next 5 Years)
| Year |
Estimated Revenue |
Average Monthly Price |
Key Drivers |
Risks |
| 2023 |
$290 million |
$2,300 |
Continued prescriber acceptance and coverage, stable demand |
Biosimilar entry, new competitors |
| 2024 |
$315 million |
$2,200 |
Growing awareness, incremental market share increases |
Patent challenges, policy shifts |
| 2025 |
$350 million |
$2,000 |
Biosimilar approvals, insurance cost-containment measures |
Price erosion from biosimilars, generic entry |
| 2026 |
$370 million |
$1,950 |
Market penetration, expanded indications |
Competition intensifies |
| 2027 |
$390 million |
$1,900 |
Increased treatment adoption, patents expiring |
Price competition, new therapeutics |
Key Takeaways
- Tymlos holds a niche but growing share in the osteoporosis market, with annual revenues near $270 million.
- Pricing hovers around $2,500–$3,200 monthly, with reductions expected as biosimilars emerge.
- Market expansion hinges on prescriber acceptance and insurance coverage.
- Biosimilar competition starting circa 2025 could precipitate price declines of 15-30%.
- Treatment growth depends on demographic trends and evolving clinical guidelines.
FAQs
Q1: What are the primary factors influencing Tymlos pricing?
Competition from biosimilars, reimbursement policies, manufacturing costs, and market demand.
Q2: How soon are biosimilars expected to enter the market?
Likely around 2025, post-patent expiration.
Q3: What patient populations are most likely to benefit from Tymlos?
Postmenopausal women at high fracture risk, especially those intolerant to bisphosphonates.
Q4: How does Tymlos compare with other osteoporosis treatments?
It offers daily subcutaneous injections with an intermediate efficacy profile between Teriparatide and Romosozumab.
Q5: What will drive market share growth for Tymlos?
Authorities favoring treatments with rapid onset, better safety profiles, and ease of use.
References
- IQVIA. (2022). Osteoporosis Treatment Market Report.
- U.S. Food and Drug Administration. (2017). Tymlos (Abaloparatide) Approval Letter.
- Evaluate Pharma. (2023). Biopharma Market Forecast.
- MMIT. (2023). Pharmaceutical Pricing Data.
- Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies and Coverage Data.
