Last updated: March 1, 2026
What is NDC 00378-7288?
NDC 00378-7288 identifies Teriparatide (Forteo) and its biosimilars. Manufactured by Eli Lilly, Forteo is indicated for osteoporosis treatment in postmenopausal women, men with osteoporosis, and patients at high fracture risk. Its indication and patent status influence market dynamics and pricing.
Market Size & Key Drivers
| Parameter |
Details |
| Global osteoporosis market size (2022) |
Estimated at $10 billion, with forecast CAGR of approximately 3% through 2028 (source: Grand View Research). |
| U.S. osteoporosis drug market |
Accounts for around 40%, driven by an aging population and increased diagnosis rates. |
| Forteo's market share (2022) |
Approximately 15-20% of osteoporosis injectable therapies. |
Main Competitors
- Bisphosphonates (e.g., alendronate, zoledronic acid)
- RANK ligand inhibitors (denosumab)
- Selective estrogen receptor modulators (raloxifene)
- Other parathyroid hormone analogs (abaloparatide)
Key Market Dynamics
- Growing prevalence: Over 54 million Americans classified as osteopenic or osteoporotic.
- Preference for oral medications reduces injectable therapy adoption.
- Forteo's efficacy reduces fracture risk but is limited by dosing frequency and side effects.
Regulatory & Patent Landscape
| Year |
Event |
Impact |
| 2017 |
Patent exclusivity expiration in the US for Forteo |
Opens opportunity for biosimilars (expected entry around 2023-2025). |
| 2022 |
FDA approvals of biosimilars (e.g., Teriparatide-linked biosimilar) |
Increases competition and pressure on price. |
| 2023 |
Pending biosimilar launches |
Seen as potential price suppressors in the near term. |
Pricing Analysis
| Product |
List Price (per 28-day dose) |
Reimbursement Complexity |
Market Penetration |
| Forteo (Eli Lilly) |
~$2,600 |
High insurance barriers |
Dominant in current market |
| Biosimilar (anticipated) |
~$1,500–$2,000 |
Lower, but variable |
Moderate, early entry stage |
Forteo’s average wholesale price (AWP): $31,200 annually (assuming 14 doses per month). Reimbursement rates vary with private insurance and Medicare.
Biosimilar price range: Expected to be 30–40% lower than Forteo, constrained initially by physician and payer acceptance.
Price Projection (2023–2028)
| Year |
Forteo (USD) |
Biosimilar (USD) |
Key Factors |
| 2023 |
$2,600 per 28-day |
$1,500–$2,000 |
Biosimilar entry begins; market share begins shift |
| 2024 |
$2,500–$2,700 |
$1,200–$1,800 |
Biosimilars capture 10–15% of prescriptions |
| 2025 |
$2,400–$2,600 |
$1,000–$1,600 |
Increased biosimilar adoption; patent challenges continue |
| 2026 |
$2,300–$2,500 |
$900–$1,400 |
Price competition intensifies, genericization expected |
| 2027 |
$2,200–$2,400 |
$750–$1,200 |
Significant biosimilar penetration; market stabilization |
| 2028 |
$2,200 |
$700–$1,000 |
Market reaches equilibrium, biosimilar dominance |
Key Market Entry and Pricing Risks
- Patent litigation may delay biosimilar market entry.
- Reimbursement policies could favor biosimilar uptake or restrict access.
- Physician preferrals may favor established brand despite lower-cost biosimilars.
Strategic Opportunities
- Launching biosimilars earlier could enable market share capture.
- Differentiating biosimilars based on delivery devices or formulary inclusion.
- Negotiating value-based reimbursement contracts with payers.
Conclusion
Forteo remains a significant osteoporosis treatment with a stable market but faces price pressure from biosimilars entering in 2023–2024. Prices are projected to decline progressively, aligned with biosimilar adoption, patent challenges, and market dynamics.
Key Takeaways
- The U.S. market for Forteo is forecasted to decline from $2,600 per 28-day dose (2023) to approximately $2,200 or lower by 2028.
- Biosimilars are anticipated to capture increasing market share, reducing overall pricing.
- Patent expirations and regulatory approvals drive biosimilar market entry in early-mid 2020s.
- Reimbursement policies significantly impact biosimilar uptake, influencing price decline trajectories.
- The overall osteoporosis market remains growth-oriented, but therapeutic preferences may shift toward oral agents, impacting injectable growth.
FAQs
1. When are biosimilars for NDC 00378-7288 expected to gain significant market share?
Biosimilars are expected to begin capturing 10–15% of prescriptions within 1–2 years following FDA approval, with further market penetration over 3–5 years.
2. How will patent expiration influence future pricing?
Patent expiration typically leads to a 30–40% decrease in price for biosimilars, with potential further declines as competition intensifies.
3. What are the main barriers to biosimilar adoption?
Physician acceptance, payer formulary restrictions, and reimbursement policies serve as the primary barriers to biosimilar market penetration.
4. How does market competition affect Forteo’s pricing?
Increased competition from biosimilars exerts downward pressure, accelerating price reductions and market share shift.
5. Are there regulatory risks that could delay biosimilar entry?
Yes; patent litigation, limited biosimilar approvals, or regulatory delays could postpone biosimilar market entry, maintaining higher prices longer.
Citations
- Grand View Research. (2022). Osteoporosis drugs market size, share & trends.
- FDA. (2022). Biosimilar approvals and guidance documents.
- IQVIA. (2023). U.S. Prescription drug market data.
- Eli Lilly. (2023). Forteo (teriparatide) prescribing information.
- EvaluatePharma. (2022). Biotechnology and biosimilars market report.
