Last updated: February 27, 2026
What is the drug with NDC 60505-4775?
The NDC 60505-4775 corresponds to Abaloparatide (Tymlos), a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. It is an anabolic agent that stimulates new bone formation.
Market Size and Demand Dynamics
Key Indications and Population
- Uses: Osteoporosis management to reduce vertebral and non-vertebral fractures.
- Target Population: Postmenopausal women aged 50 and older.
- Estimated US Population: Approximately 16 million postmenopausal women with osteoporosis, with high fracture risk estimated at 2-4 million.
Market Penetration
- Prescription Volume: As of 2022, roughly 50,000 to 70,000 prescriptions annually in the U.S.
- Adoption: Steady growth driven by increasing awareness of osteoporosis and new treatment options.
- Competition: Mainly from teriparatide (Forteo), romosozumab (Evenity), and bisphosphonates.
Market Share
- Estimated prescription share: Tymlos accounts for about 25-35% of anabolic osteoporosis prescriptions, influenced by clinician preferences, reimbursement policies, and patient compliance issues.
Pricing Landscape
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $4,000 to $5,000 per 28-day supply.
- Average Selling Price (ASP): Slightly lower, in the range of $3,200 to $4,200.
- Reimbursement: Typically covered by Medicare Part D, commercial insurers, with patient co-pays varying based on plans.
Pricing Comparison to Competitors
| Drug |
WAC per 28-day supply |
Indication |
Note |
| Abaloparatide (Tymlos) |
$4,800 |
Osteoporosis in high-risk women |
High cost, limited by prescriber preference |
| Teriparatide (Forteo) |
$4,400 |
Similar indication |
Slightly lower price |
| Romosozumab (Evenity) |
$2,600 |
Osteoporosis in postmenopausal women with high fracture risk |
Relatively lower cost yet single-dose monthly |
Revenue Projections
- Market Size (2023): Approximate U.S. sales estimated at $250 million.
- Growth Rate: Projected compound annual growth rate (CAGR) of 10-12% over the next five years, driven by increased adoption and expanded indications.
- Export Markets: Canada, EU, and Asia are emerging markets, with local prices typically 50-70% of U.S. levels.
Pricing Trends and Regulatory Factors
- Industry pricing pressures may influence WAC reductions, competition from biosimilars if approved.
- Payer negotiations increasingly impact net prices.
- Value-based reimbursement models could incentivize price adjustments based on clinical outcomes.
Market Entry and Future Pricing Considerations
- Entry Barriers: Patent exclusivity maintains market control until at least 2027.
- Biosimilar Competition: No biosimilars currently approved but potential candidates are in development.
- Price Sensitivity: Payers prioritize cost-effectiveness; oral alternatives and biosimilar entries could pressure prices downward.
Key Factors Influencing Price Projections
| Factor |
Impact |
| Patent status and exclusivity |
Maintains pricing power until patent expiry |
| Competition from biosimilars or generics |
Likely to reduce prices post-approval |
| Healthcare policy shifts |
Increased cost containment, impacting reimbursement |
| Expansion of indications |
Could sustain or increase price levels |
Summary of Projection
| Year |
Estimated WAC Price Range |
Notes |
| 2023 |
$4,200 – $5,000 |
Current market conditions, stable demand |
| 2025 |
$4,000 – $4,800 |
Anticipation of payer negotiations, slight declines |
| 2027 |
$3,500 – $4,500 |
Possible patent expiry or biosimilar market entry |
Final notes
- Variability in pricing can occur based on payer mix, contracts, and regional factors.
- The forecast assumes no major policy changes or patent challenges.
- Price erosion is expected with increased biosimilar competition and generic entries.
Key Takeaways
- Abaloparatide's market in the U.S. is valued at approximately $250 million annually, with steady growth expected.
- Current prices are around $4,800 per month, impacted by market dynamics, payer negotiations, and competition.
- The market is poised for moderate price declines over the next few years, especially post-patent expiry.
- Entry of biosimilars could significantly compress the price landscape.
- Expansion into international markets presents an opportunity for revenue growth but subject to local pricing policies.
FAQs
Q1: When is patent expiry expected for Abaloparatide?
A1: Patent exclusivity extends until at least 2027, after which biosimilars may enter the market.
Q2: How does Abaloparatide compare economically to other osteoporosis treatments?
A2: It is priced higher than bisphosphonates and similar to teriparatide, but off-label or generic options may offer lower-cost alternatives.
Q3: What are the driver factors for future price reduction?
A3: Biosimilar approval, market competition, regulatory changes, and payer negotiations.
Q4: Is international pricing aligned with the U.S.?
A4: No; many countries implement price controls leading to lower prices, often 50-70% of U.S. levels.
Q5: What factors could boost prices in the upcoming years?
A5: Expanded indications, improved patient access, and increased adoption among clinicians.
References
- Food and Drug Administration. (2019). Tymlos (abaloparatide) prescribing information.
- IQVIA. (2022). U.S. Prescription Trends for Osteoporosis Medications.
- U.S. Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Reimbursement Data.
- EvaluatePharma. (2022). Osteoporosis Market Report.
- Pharma Intelligence. (2022). Biosimilar Development Pipeline Analysis[1-5].
[1] APA citations omitted for brevity; full references available upon request.
