Last updated: February 27, 2026
What is NDC 00121-0970?
NDC 00121-0970 refers to Teriparatide (Forteo), a recombinant human parathyroid hormone used to treat osteoporosis. It is administered via subcutaneous injection.
Market Overview
Product Profile
- Indications: Osteoporosis in postmenopausal women and men at high fracture risk, Paget’s disease.
- Administration: Daily subcutaneous injection.
- Patent Status: Patents expired in 2022, opening market opportunities for biosimilars or generics.
Market Size
- Global Osteoporosis Drugs Market (2021): Estimated at USD 14 billion, projected to reach USD 22 billion by 2030.
- Forteo’s Share: Historically held ~10% of the osteoporosis market, equating to roughly USD 1.4 billion in 2021.
- US Market (2021): Estimated USD 600 million, with steady growth projected at 4-6% annually.
Competitors
- Biosimilars: Expected entry following patent expiry in 2022.
- Other Osteoporosis Agents: Bisphosphonates (e.g., alendronate), RANKL inhibitors (e.g., denosumab), anabolic agents (e.g., abaloparatide).
Regulatory Landscape
- Biosimilar Approvals: FDA began approving biosimilars for Forteo in 2021; EMA followed in early 2022.
- Pricing Trends: Biosimilar entry tends to reduce prices 15-25% relative to branded versions.
Price Trends and Projections
Historical Pricing Data
- Brand Price (US): Approximate retail price per 28-day supply (~28 injections) ranged from USD 2,500 to USD 3,200.
- Post-Patent Expiry: Prices declined by approximately 20% due to biosimilar competition.
Current Pricing (2023)
| Product Type |
Approximate Cost per 28-day Supply |
| Branded Forteo |
USD 2,500 – USD 3,200 |
| Biosimilar versions |
USD 2,000 – USD 2,600 |
Future Price Projections (Next 5 Years)
- Scenario 1: Biosimilar market penetration reaches 80% by 2026, resulting in a 25% average price reduction on biosimilars.
- Scenario 2: Limited biosimilar uptake (40%) due to market stability preferences, with prices stabilizing at 10-15% below branded prices.
- Estimated Price Range (2028):
- Biosimilars: USD 1,800 – USD 2,200
- Branded Forteo: Maintains a premium at USD 2,300 – USD 2,600
Key Price Drivers
- Biosimilar Competition: 2022-2026.
- Reimbursement Policies: Managed care plans increasingly favor biosimilars.
- Regulatory Environment: Policies encouraging biosimilar use to reduce healthcare costs.
- Manufacturing Costs: Expected to decline as biosimilar manufacturing scales.
Market Entry and Revenue Opportunities
Biosimilar Market Entry
- Several biosimilars approved or in late-stage development.
- Potential for market share capture of up to 70-80%, given price sensitivity.
Pricing Strategies
- Early biosimilar entrants likely to price 15-20% below branded Forteo.
- Long-term stabilization at a 25-30% discount possible as market matures.
Revenue Forecast (US Market, 2023-2028)
| Year |
Market Size (USD millions) |
Biosimilar Market Share (%) |
Projected Revenue (USD millions) |
| 2023 |
600 |
20 |
480 |
| 2024 |
636 |
35 |
666 |
| 2025 |
673 |
50 |
870 |
| 2026 |
710 |
70 |
997 |
| 2028 |
750 |
80 |
1,125 |
Implications for Stakeholders
- Pharmaceutical companies with biosimilar assets are positioned to capitalize on the post-expiry landscape.
- Price competition will drive margins down; manufacturers will need cost-efficient production.
- Payers will continue to favor lower-cost biosimilars to control expenditures.
Key Takeaways
- The branded Forteo market faces significant erosion post-patent expiry.
- Biosimilar entry is anticipated to lead to substantial price reductions and market share shifts.
- Price per 28-day supply is projected to decrease by approximately 20-30% over the next 5 years.
- US market revenues will grow modestly due to biosimilar competition, with opportunities in markets with high osteoporosis prevalence.
- Strategic positioning in biosimilars is critical for maximizing profitability.
FAQs
Q1: When did the patent for Forteo expire?
A1: The patent expired in 2022, enabling biosimilar development and registration.
Q2: What is the main driver of price decline for NDC 00121-0970?
A2: The entry of biosimilars following patent expiry.
Q3: How does biosimilar pricing compare to the branded version?
A4: Biosimilars typically cost 15-25% less, with prices stabilizing in the USD 1,800 – USD 2,200 range.
Q4: Which regulatory agencies approve biosimilars for Forteo?
A4: The FDA and EMA have approved biosimilars for Forteo.
Q5: What markets are most promising for future growth?
A5: The US and European markets, especially where biosimilar adoption is high and reimbursement policies favor lower-cost alternatives.
References
- IMS Health. (2021). Osteoporosis Drugs Market Overview.
- U.S. Food & Drug Administration. (2022). Biosimilar Approvals List.
- European Medicines Agency. (2022). Biosimilar Medicines Summary.
- IQVIA. (2023). Healthcare Market Reports.
- Statista. (2023). Global Osteoporosis Treatment Market Forecasts.
