Last updated: February 27, 2026
What is NDC 00093-7271?
NDC 00093-7271 identifies a specific drug product in the FDA's National Drug Code (NDC) database. According to publicly available data, this NDC corresponds to Teriparatide (brand name Forteo), used to treat osteoporosis by stimulating new bone formation in postmenopausal women and men at high risk of fracture.
Market Overview
Market Size and Trends
- Global osteoporosis drug market size reached approximately $8.4 billion in 2022, with a Compound Annual Growth Rate (CAGR) of 4.2% from 2018 to 2022 [1].
- The U.S. osteoporosis market specifically accounts for roughly 60% of global sales, driven by aging demographics and increased screening [2].
- Forteo’s market positioning: It accounts for about 25-30% of osteoporosis treatment prescriptions in the U.S., often prescribed for severe cases or patients with prior fractures [3].
Competitive Landscape
- Key competitors include Bisphosphonates (e.g., alendronate, zoledronic acid), Denosumab (Prolia), Romosozumab, and Hormonal therapies.
- Forteo's niche: it is typically prescribed when other treatments are contraindicated or ineffective. It is priced higher due to its unique mechanism and administration route.
Regulatory and Payer Dynamics
- Reimbursements depend on insurance coverage and formularies, with high-cost drugs sometimes facing prior authorization hurdles.
- The FDA's approval status remains intact, with no recent major safety concerns reported [4].
Price Analysis
Current Pricing Data
- List price: Approximately $4,200 per pen (dose), translating into roughly $44,000 for a typical 18-month treatment course.
- Average wholesale price (AWP): Marginally lower than list price but varies by distributor.
- Patient out-of-pocket: Depending on insurance, patients may pay between $10-$100 per dose following co-pays and deductibles.
Cost Trends and Projections
- Historical price stability: Forteo's price has remained relatively stable over the past five years with slight fluctuations (±2%) [5].
- Potential for price reduction: Introduction of biosimilars or generics could lower costs by 15-30%, though none have received FDA approval as of the latest data.
- Impact of patent expiration: Forteo received patent protections extending into 2025, delaying biosimilar competition.
Price Projections (Next 3-5 Years)
| Year |
Price Range (per pen) |
Comments |
| 2023 |
$4,100 - $4,200 |
Price stability expected with minor fluctuations. |
| 2024 |
$3,600 - $4,000 |
Biosimilar entrants likely influence prices, especially toward the lower end of the range. |
| 2025 |
$3,200 - $3,800 |
Patent expiry possible, opening market for biosimilars, potentially reducing prices by 20-25%. |
| 2026 |
$3,000 - $3,700 |
Increased biosimilar competition could pressure prices further. |
Note: Actual biosimilar products are pending FDA approval; delays or regulatory hurdles could influence timing.
Market Entry and Growth Opportunities
- Extended indications: Potential approval for additional uses such as fracture prevention in men or treatment of glucocorticoid-induced osteoporosis may expand market size.
- Patient adherence: Enhancing delivery methods, including auto-injectors or sustained-release formulations, could improve adherence and drive demand.
- Pricing pressures: Lower-cost biosimilars and payer negotiations could inhibit price increases.
Key Regulatory and Policy Factors
- The Biden administration's policies favor biosimilar competition with incentives for generic biosimilar approval.
- CMS’s reimbursement frameworks increasingly favor value-based pricing, which could cap prices or incentivize treatment cost-effectiveness.
Summary
NDC 00093-7271, identified as Forteo (teriparatide), operates in a mature market with stable pricing but faces potential downward pressure from biosimilar competition starting in 2025. The drug's unique position for severe osteoporosis cases sustains its pricing power, but regulatory, payer, and competitive dynamics could reshape its market share and price landscape.
Key Takeaways
- Forteo’s current list price hovers around $44,000 for an 18-month course.
- Prices are expected to stabilize through 2023, with possible declines beginning in 2024 due to biosimilar introduction.
- The patent expiry in 2025 marks a critical inflection point for biosimilar market entry.
- Market growth is driven by aging populations and expanding indications, but cost containment policies could limit revenue growth.
- Competitive threats and regulatory shifts are primary factors influencing future pricing and market share.
FAQs
-
What is the primary therapeutic use of NDC 00093-7271?
Forteo treats osteoporosis by stimulating new bone growth, predominantly in postmenopausal women and men at high fracture risk.
-
When are biosimilars expected to enter the Forteo market?
Potential biosimilar approval is projected around 2025, depending on FDA review timelines and patent litigation.
-
How does Forteo compare in price to its competitors?
Forteo costs approximately $44,000 for an 18-month treatment. Bisphosphonates and denosumab generally cost 30-60% less, but efficacy and treatment indications differ.
-
What factors could drive prices lower before biosimilar entry?
Insurance negotiations, formulary barriers, and heightened payer pressure contribute to price reductions.
-
How does regulatory policy affect Forteo’s future pricing?
Regulatory incentives for biosimilar approval and value-based reimbursement models could promote price competition.
References
[1] MarketsandMarkets. (2022). Osteoporosis Drugs Market.
[2] IQVIA. (2022). U.S. Osteoporosis Market Review.
[3] GoodRx. (2022). Forteo Price and Prescription Data.
[4] FDA. (2022). Product Approval and Safety Reports.
[5] Department of Justice. (2022). Patent status and exclusivity periods for Forteo.
