Last updated: February 24, 2026
What is the Drug Associated with NDC 65862-0766?
NDC 65862-0766 corresponds to Abaloparatide, marketed under the brand name Tymlos. It is an injectable peptide used to treat postmenopausal women with osteoporosis at increased risk for fracture. Abaloparatide stimulates bone formation similar to Teriparatide but distinguishes itself via receptor selectivity.
Current Market Landscape
Market Size and Growth Drivers
- The global osteoporosis treatment market was valued at approximately $6.4 billion in 2022.
- Compound annual growth rate (CAGR) projected at 4.8% from 2023 to 2030 (ResearchAndMarkets, 2023).
- Factors fueling growth include aging populations, increased osteoporosis awareness, and new treatment options.
Competitive Position
- Tymlos competes primarily with Teriparatide (Forteo), Romosozumab (Evenity), and Bisphosphonates.
- Leading competitors' pricing in North America:
- Teriparatide: ~$2,700 per 30-day supply
- Romosozumab: ~$2,600 per month
- Tymlos's pricing is between $2,100 and $2,400 per month, reflecting its positioning and dosing schedule (GoodRx, 2023).
Patent and Regulatory Status
- Tymlos was approved by FDA in 2017.
- Abaloparatide's patent protection extends until at least 2030, providing market exclusivity.
Pricing Trends and Projections
Historical Pricing Data
| Year |
Average Monthly Wholesale Price (USD) |
Notes |
| 2018 |
~$2,600 |
Post-launch stabilization |
| 2020 |
~$2,200 |
Slight decline due to market competition |
| 2022 |
~$2,200–$2,400 |
Stabilization, ongoing negotiations |
Future Price Projections (2023-2030)
- Short-term (2023-2025): Prices will likely remain stable around $2,200–$2,400 per month due to market share and patent protection.
- Mid-term (2026-2028): Potential price erosion to ~$2,000-$2,200 due to biosimilar entrants approaching patent expiry.
- Long-term (2029-2030): Pricing could decline further to ~$1,800–$2,000 with increased biosimilar competition and patent expiration.
Impact of Biosimilar Entry
- Biosimilar drugs targeting abaloparatide are expected to enter the market around 2028-2030.
- Biosimilar pricing typically 20-30% lower than branded versions, potentially reducing Tymlos’s price by similar percentages.
Price Setting Factors
- Reimbursement policies in the US and Europe.
- Insurance coverage and negotiated discounts.
- Patent protection timelines.
- Market penetration and clinical positioning.
Revenue and Market Share Projections
Revenue Estimates
| Year |
Estimated Sales (USD millions) |
Assumptions |
| 2023 |
~$400–$500 |
Market share stabilizing at current levels |
| 2025 |
~$500–$600 |
Slight increase as awareness grows |
| 2030 |
~$700–$900 |
Post-patent, with increased biosimilar competition |
Market Penetration
- Initially targets postmenopausal osteoporosis patients with high fracture risk (~6 million in US alone).
- Market penetration expected to plateau at 15-20% of eligible patients within 5 years post-launch.
Opportunities and Risks
Opportunities
- Expansion into male osteoporosis and glucocorticoid-induced osteoporosis.
- Development of combination therapies.
- Increasing screening and diagnosis of osteoporosis.
Risks
- Patent expiration leading to biosimilar erosion.
- Regulatory changes impacting pricing.
- Market saturation and increased competition.
Key Takeaways
- Tymlos remains a premium-priced osteoporosis drug with stable short-term pricing.
- Market share growth depends on clinician adoption and insurance reimbursement policies.
- Price decline is feasible starting 2026, influenced by biosimilar entry.
- Long-term revenue projections suggest moderate growth, constrained by patent expiry and biosimilar competition.
- Broader osteoporosis treatment landscape, including new agents and formulations, could impact future pricing and market size.
FAQs
1. When is biosimilar competition expected for Abaloparatide?
Biosimilars could enter the market around 2028-2030, roughly 8-10 years after FDA approval, following patent expiry.
2. How does the pricing of Abaloparatide compare with similar drugs?
Tymlos's current cost (~$2,200–$2,400/month) aligns with Romosozumab but remains higher than Bisphosphonates (~$200/month). It is lower than Teriparatide (~$2,700/month).
3. What factors could influence the drug’s price in the next five years?
Patent expiration, biosimilar entry, reimbursement policy shifts, negotiated discounts, and clinical guideline updates.
4. What is the estimated global market size for osteoporosis treatments?
Approximately $6.4 billion in 2022, with a CAGR of 4.8% forecasted through 2030.
5. How significant is Abaloparatide's patent protection?
Patent protection extends until at least 2030, delaying biosimilar market entry and supporting current pricing strategies.
References
[1] ResearchAndMarkets. (2023). Global Osteoporosis Drugs Market Report.
[2] GoodRx. (2023). Osteoporosis Drug Pricing Data.
[3] U.S. Food and Drug Administration. (2017). Tymlos (Abaloparatide) drug approval.
