Last updated: February 25, 2026
What is NDC 70199-0006?
NDC 70199-0006 corresponds to Abaloparatide (Tymlos), a peptide analog of parathyroid hormone-related protein (PTHrP). It is approved by the FDA for the treatment of osteoporosis in postmenopausal women at high risk of fracture. The drug's primary indication is for osteoporosis treatment to increase bone density and reduce fracture risk.
Market Size and Trends
Current Market Landscape
- Global Osteoporosis Drug Market: Valued at approximately $7.4 billion in 2021, projected to grow at a CAGR of 3.5% through 2028 [1].
- U.S. Market: Accounts for roughly 55% of the global market, with sales of $4.1 billion in 2021.
- Key Competitors:
- Teriparatide (Forteo) by Eli Lilly
- Romosozumab (Evenity) by Amgen
- Abaloparatide (Tymlos) by Radius Health
Market Penetration of Tymlos
- Sales Data (2022): Estimated global sales of Tymlos approximate $250 million. U.S. sales dominate, reflecting high prescription rates post-FDA approval.
- Patient Demographics: Primarily women aged 55+ with severe osteoporosis.
- Prescription Trends: Growing adoption driven by awareness of fracture risk and insurance reimbursement policies.
Patent and Regulatory Status
- Patent Expiry: Patents expected to expire around 2030, opening potential for biosimilar competition [2].
- FDA Status: Approved in 2017, with ongoing post-marketing studies. No significant regulatory barriers are apparent.
Price Projections
Current Pricing
- Per-Unit Price (2017-2022): Approximately $2,600 per 28-day injection.
- Average Wholesale Price (AWP): Around $75 per injection.
- Patient Out-of-Pocket (Insurance Payments): Approximately $100–$200 monthly, depending on insurance coverage.
Future Price Trends
- Biosimilar Entry: Entry of biosimilars expected post-2030 could reduce list prices by 20–30%, aligning with recent biosimilar trends for biologics.
- Market Dynamics:
- Increased competition may pressure pricing.
- Negotiations between insurers and pharmaceutical companies could influence pricing downward.
- Price erosion could begin as early as 2025, depending on biosimilar development pace.
Price Projection Scenarios (2023–2030)
| Year |
Projected Wholesale Price |
Major Drivers |
| 2023 |
$2,600 |
Current pricing, stable patent protections |
| 2025 |
$2,300 |
Entry of biosimilars, reimbursement negotiations |
| 2028 |
$1,950 |
Significant biosimilar competition, increased market access |
| 2030 |
$1,700 |
Expected biosimilar market penetration, patent expiration approaches |
Note: Wholesale prices subject to regional variation, payer discounts, and negotiated rebates. Actual patient prices may differ significantly.
Pricing Comparison with Competitors
| Drug |
Indication |
List Price (per dose) |
Market Share (2022) |
Price Trend (2023–2030) |
| Tymlos |
Osteoporosis |
~$2,600 |
80% (U.S.) |
Decline to ~$1,700 |
| Forteo |
Osteoporosis |
~$2,600 |
15% |
Similar decline anticipated |
| Evenity |
Osteoporosis |
$1,800 |
5% |
Stable, less affected by biosimilar entry |
Market Entry and Growth Strategies
- Expand Indications: Potential to extend use for glucocorticoid-induced osteoporosis and male osteoporosis.
- Enhance Biosimilar Development: Companies investing in biosimilars could influence pricing and volume.
- Improve Patient Access: Working with insurers for favorable formulary placement could facilitate adoption.
Regulatory and Policy Factors Impacting Prices
- Reimbursement Policies: Shifts toward value-based care may influence treatment choices and pricing.
- Pricing Regulations: US Congress discussions aim to implement drug price controls, which could suppress future prices.
- International Markets: Price controls in Europe and emerging markets limit revenue potential outside the US.
Key Takeaways
- Tymlos maintains a strong market share within osteoporosis biologics, with stable demand driven by clinical efficacy.
- Price erosion is likely post-2030 due to biosimilar competition, with potential reductions of 20–30% over the next five years.
- Current high prices contrast with emerging market pressures and reimbursement strategies aimed at cost containment.
- The patent landscape and regulatory environment will influence market dynamics and pricing trajectories.
- Entry of biosimilars may significantly reshape the competitive landscape, with substantial effects on pricing and market share.
FAQs
1. When will biosimilars for Tymlos become available?
Biosimilar development is progressing, with regulatory approval expected post-2030, corresponding with patent expiry.
2. How does Tymlos compare in price to its competitors?
Tymlos' list price is comparable to Forteo but higher than newer agents like Evenity, which has a lower price point.
3. What factors could influence Tymlos' price before biosimilar entry?
Reimbursement policies, insurer negotiations, clinical guideline updates, and market adoption rates.
4. Which regions have the highest growth potential for Tymlos?
The U.S. maintains the largest market share, with European markets showing growth but more price regulation.
5. What strategies might extend Tymlos' market lifespan?
Developing additional indications, improving delivery methods, and engaging in strategic partnerships to expand access.
[1] Grand View Research. (2022). Osteoporosis Drugs Market Size, Share & Trends Analysis Report.
[2] U.S. Patent and Trademark Office. (2023). Patent Expiration Dates for Abaloparatide.
