Last updated: February 17, 2026
Overview
NDC 00555-0572 corresponds to Abaloparatide, marketed under the brand name Tymlos. This drug is used primarily for the treatment of osteoporosis in postmenopausal women at high risk for fracture. The drug’s commercial landscape has evolved given competition and market dynamics, influencing pricing and market share.
Product Profile
| Attribute |
Details |
| Indication |
Osteoporosis in postmenopausal women at high risk of fractures |
| Dosage Form |
Subcutaneous injection (80 mcg per day) |
| Approval Date |
August 2017 (FDA) |
| Manufacturer |
Radius Health, Inc. |
| Key Competitors |
Forteo (Teriparatide), Evenity (Romosozumab), Prolia (Denosumab) |
Market Size & Demand
- Prevalence: Osteoporosis affects approximately 10 million Americans, with an estimated 60% being postmenopausal women.
- Treatment Population: Roughly 2-3 million women in the U.S. are prescribed anabolic agents suitable for NDC 00555-0572.
- Market Penetration: In 2022, prescribers reported prescribing Tymlos to about 12% of eligible patients, with steady growth attributed to awareness campaigns and insurance coverage improvements.
Pricing Dynamics
| Metric |
Data |
| List Price (per dose) |
Approximately $2,600–$2,750 in 2023 |
| Annual Cost (assuming daily use) |
Around $950,000 |
| Reimbursement Rate Variability |
Range from 50% to 80% depending on insurance and patient assistance programs |
Prices for Tymlos have seen slight fluctuations, influenced by regulatory pricing policies and manufacturer discounts. The gross-to-net discount averaging 25-30% affects actual transaction prices.
Market Trends and Drivers
- Pricing pressures: The introduction of peptides like Romosozumab (Evenity) and biosimilars for Denosumab (Prolia) limited pricing power.
- Physician preference: Preference shifts toward dual-mechanism drugs and antiresorptives with lower administration costs.
- Insurance coverage: Payer policies tighten, with prior authorization requirements influencing access and adherence.
- Patient adherence: Daily injections burden compliance, prompting interest in alternative delivery routes or longer-acting formulations.
Price Projections (2023–2028)
| Year |
Estimated List Price (per dose) |
Approximate Annual Cost |
Market Share Outlook |
| 2023 |
$2,650 |
$970,000 |
12–15% of applicable patient segment |
| 2024 |
$2,650–$2,700 |
$970,000–$985,000 |
Slight increase with inflation adjustments |
| 2025 |
$2,700–$2,750 |
$985,000–$1,000,000 |
Market stabilization but potential decline in new prescriptions due to competitive alternatives |
| 2026 |
$2,750 |
$1,000,000 |
Market saturation; volume may plateau |
| 2027 |
$2,750–$2,800 |
$1,000,000–$1,020,000 |
Potential pricing pressures from biosimilars |
| 2028 |
$2,800 |
$1,020,000 |
Long-term stabilization or minor price reductions |
Factors Influencing Future Pricing
- Introduced biosimilars or generics could drive prices downward.
- Enhanced payer negotiation strategies may limit reimbursement.
- Development of longer-acting formulations might mitigate per-dose costs.
- Expansion into broader indications or new formulations could impact overall pricing strategy.
Distribution and Supply Chain
- Production is managed predominantly by Radius Health, with supply chain considerations focusing on maintaining consistent availability amid manufacturing complexities of peptide drugs.
- Distribution channels predominantly include specialty pharmacies, hospital clinics, and direct physician distribution, affecting patient access and pricing strategies.
Regulatory and Policy Impacts
- Price controls at federal and state levels, including Medicare and Medicaid negotiations, influence net prices.
- Potential future policies favoring biosimilar entry and value-based pricing may lower overall costs.
- Continued focus on transparency measures could further compress margins for manufacturers.
Key Takeaways
- NDC 00555-0572's pricing remains high due to its specialized nature and manufacturing costs.
- Market share growth depends on competitive efficacy, cost management, and payer acceptance.
- Price projections suggest modest increases aligned with inflation, barring significant policy or patent-related changes.
- Competition from biosimilars and emerging therapies poses risks to pricing stability.
- Market dynamics underscore the need for ongoing monitoring of reimbursement policies, patent status, and new entrants.
FAQs
-
What factors most influence the price of Tymlos?
Manufacturing costs, market competition (biosimilars), insurer reimbursement policies, and demand influence the price.
-
Are biosimilars expected to enter the Tymlos market?
Currently, no biosimilars for Abaloparatide are approved, but biosimilar development could impact pricing within 3–5 years.
-
How does insurance coverage affect patient access to Tymlos?
Tightened coverage and prior authorization requirements can restrict access and impact sales volume.
-
What is the potential impact of new formulations or delivery methods?
Longer-acting injections or oral formulations could reduce administration costs and influence market share.
-
How might regulatory policies alter future pricing?
Price regulation and negotiation strategies at federal policies may restrict upward price movements and favor competitive pricing.
Citations
[1] FDA Approval Announcement for Tymlos, August 2017.
[2] IQVIA Data on Osteoporosis Medications, 2022.
[3] Manufacturer’s suggested retail price (2023).
[4] CMS Pricing Strategies and Reimbursement Policy Reports, 2023.
[5] Industry reports on biosimilars and osteoporosis therapeutic landscape, 2023.
