Last updated: February 17, 2026
Overview
NDC 00115-4411 corresponds to Forteo (teriparatide injection), a prescription medication used for osteoporosis treatment. It is marketed by Eli Lilly and Company. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2002.
Market Size and Demand
- Target Patients: Primarily postmenopausal women with osteoporosis, men with osteoporosis, and individuals at high fracture risk, including those with glucocorticoid-induced osteoporosis.
- Market Value: The global osteoporosis market was valued at approximately $11 billion in 2022. The U.S. accounts for nearly half of this market.
- Market Dynamics: The aging population drives demand. Osteoporosis treatment prescriptions increased by approximately 6% annually from 2018 to 2022 in the U.S.
- Competitive Landscape: Forteo faces competition from bisphosphonates (e.g., alendronate), selective estrogen receptor modulators (e.g., raloxifene), and newer agents like romosozumab (Skyclarys).
Pricing Landscape
- Current U.S. List Price: The average wholesale price (AWP) for Forteo is approximately $2,800 per 28-day supply. Insurance reimbursement reduces out-of-pocket costs for most patients.
- Price Trends: The price has remained relatively stable over the past three years. However, rebates and contracting agreements often diminish the effective price paid by payers.
Reimbursement and Cost Factors
- Medicare Coverage: Forteo covered under Medicare Part B, with typical patient copays between $50 and $150 monthly, depending on the insurance plan.
- Drug Cost Controls: Patent exclusivity expires in 2024, opening the market to biosimilars, which could reduce prices by 20-40%.
Future Price Projections
| Year |
Estimated Wholesale Price per 28-Day Supply |
Notes |
| 2023 |
$2,800 |
Current baseline. Reimbursement trends apply. |
| 2024 |
$2,600 |
Slight decrease anticipated due to patent expiry and biosimilar entry. |
| 2025 |
$2,300 |
Increased biosimilar competition expected. |
| 2026 |
$2,000 |
Price reduction stabilizes as biosimilars capture market share. |
| 2027 |
$1,800 |
Further competition may further push prices downward; premium products might retain higher margins. |
Note: Projections assume no major regulatory changes, market expansion, or supply chain disruptions.
Regulatory and Patent Considerations
- Patent Status: The original patent expired in 2024, with supplemental patents possibly extending exclusivity until 2026-2027.
- Biosimilar Development: Companies like Teva and Amneal are developing biosimilars for teriparatide, which could enter the market within 1-2 years post-patent expiry.
Pricing Impact of Biosimilars
- Biosimilars typically enter at a 20-40% discount to the originator. The initial biosimilar price may start around $2,000-$2,200 per 28-day supply.
- Market adoption depends on formulary preferences, physician prescribing behavior, and patient acceptance.
Risk Factors
- Market Penetration: Slow adoption of biosimilars could sustain higher prices.
- Regulatory Delays: Any delays in biosimilar approval could extend Forteo's pricing dominance.
- New Therapeutics: Innovation in osteoporosis treatments may alter market dynamics.
Key Takeaways
- Forteo remains a critical drug for specific osteoporosis populations with a current list price of approximately $2,800 per 28-day supply.
- Entry of biosimilars in 2024 is expected to reduce competition-driven pricing, potentially lowering prices by 20-30% within two years.
- Market demand driven by an aging population supports steady revenue in the near term, but patent expirations introduce downward pressure.
- Reimbursement policies and insurance dynamics significantly influence the net prices paid by payers and patients.
- Long-term price trajectories depend on regulatory developments, competitive responses, and clinical adoption patterns.
FAQs
-
What is the primary indication for NDC 00115-4411?
For osteoporosis treatment in postmenopausal women, men with osteoporosis, and fracture risk reduction.
-
How does the current drug price compare globally?
International prices vary; in some countries, reimbursement or national pricing policies reduce prices to below $1,500 per 28-day supply.
-
What are the prospects for biosimilar entry?
Biosimilars are expected to enter the market in 2024, with initial discounts of 20-30% relative to Forteo.
-
How does patient access influence the market?
Insurance coverage and copayment structure determine access; high out-of-pocket costs can limit utilization.
-
What strategies might Eli Lilly pursue post-patent expiration?
Potential strategies include improving biosimilar partnerships, optimizing pricing models, and expanding indications or formulations.
References
[1] IQVIA, 2022. US Prescription Drug Market Reports.
[2] FDA, 2002. Approval of Forteo.
[3] Eli Lilly, 2023. Forteo Pricing and Reimbursement Data.
[4] MarketWatch, 2023. Osteoporosis Market Analysis.
