Last updated: February 14, 2026
What is NDC 00245-5317?
NDC 00245-5317 is a specific drug identified by the National Drug Code. It is manufactured by Teva Pharmaceuticals. Based on available data, this NDC corresponds to Risedronate Sodium DR 35 mg, a bisphosphonate used primarily to treat osteoporosis and Paget's disease.
Market Size and Demand Drivers
Global Osteoporosis Market
The osteoporosis treatment market is valued at approximately $8 billion in 2022 and is projected to grow at a CAGR of 3-4% over the next five years. The key drivers include aging populations, increased osteoporosis awareness, and expanding diagnosis rates.
Key Geographic Markets
- North America: 45% of the global market, with high treatment adherence and reimbursement.
- Europe: 25%, with expanding public health initiatives.
- Asia-Pacific: 20%, driven by aging demographics and increasing healthcare access.
- Rest of the world: 10%, lower treatment penetration.
Market Segments
The bisphosphonate segment accounts for around 65% of the osteoporosis drugs market. Risedronate is among top-prescribed drugs due to its efficacy and established safety profile.
Competitive Landscape
Main competitors include Alendronate (Fosamax), Ibandronate (Boniva), and Zoledronic Acid (Reclast). Risedronate captures about 15-20% of prescription volume in its category, attributed to its dosing flexibility (weekly and monthly formulations).
Pricing Dynamics and Regulatory Factors
Current Pricing Trends
- Brand name (Actonel): ~$400–$600/month (or ~$4,800–$7,200/year).
- Generics: ~$200–$350/month (~$2,400–$4,200/year).
Market Entry and Competition
Patent expiration for original formulations occurred around 2015-2017, leading to an influx of generics and significant price erosion. The current market is dominated by generics, which have flattened price fluctuations over recent years.
Regulatory Environment and Reimbursement
In the US, reimbursement policies favor generics, leading to lower out-of-pocket costs for patients. In Europe, pricing varies by country, with some countries negotiating price caps.
Price Projections (2023–2028)
| Year |
Estimated Average Monthly Price (USD) |
Notes |
| 2023 |
$210–$350 |
Dominance of generics, stable pricing. |
| 2024 |
$200–$340 |
Slight declines expected owing to patent challenges. |
| 2025 |
$190–$330 |
Increased generic market penetration. |
| 2026 |
$180–$320 |
Further price stabilization and potential biosimilar entry. |
| 2027 |
$170–$310 |
Market saturation, minor price erosion. |
| 2028 |
$160–$300 |
Expected price floor for mature generics. |
Factors Influencing Future Pricing
- Introduction of biosimilars or alternative formulations.
- Changes in patent legal status or exclusivity periods.
- Reimbursement shifts in public and private payers.
- Advances in osteoporosis treatments reducing demand for bisphosphonates.
- Patent litigation affecting generic market share.
Key Considerations for Stakeholders
- Manufacturers: Focus marketing on differentiated formulations or combination therapies.
- Investors: Monitor patent timelines, regulatory approvals of biosimilars, and payer policies.
- Healthcare Providers: Stay updated on emerging treatments that could replace bisphosphonates, impacting volume.
Key Takeaways
- NDC 00245-5317 (Risedronate Sodium DR 35 mg) operates in a mature, price-competitive market.
- Generics dominate, maintaining a downward pressure on prices.
- Market size is projected to grow modestly, driven by demographic trends.
- Price erosion is expected to continue, with annual prices stabilizing around $160–$300 by 2028.
- Regulatory and technological shifts could influence future price dynamics and market share.
Frequently Asked Questions
1. How does patent expiration impact the price of NDC 00245-5317?
Patent expiration typically results in generics entering the market, significantly lowering the price due to increased competition.
2. What are the major factors that could change the price projections?
Introduction of biosimilars, new treatment guidelines, regulatory changes, and patent litigation.
3. How does reimbursement policy influence drug pricing?
Reimbursement policies favor lower-cost generics, resulting in reduced out-of-pocket costs and downward price pressure.
4. Are there any upcoming regulatory approvals that could affect this drug's market?
Potential biosimilar approvals or new formulations could alter competitive dynamics.
5. What is the outlook for company profits related to this NDC?
Profitability depends on manufacturing costs, market share, and pricing erosion, with margins compressing as generics dominate.
References
[1] MarketWatch. "Osteoporosis Drugs Market Size and Growth." 2022.
[2] IQVIA. "Global Osteoporosis Market Analysis." 2022.
[3] EvaluatePharma. "Generic Drug Price Trends." 2022.
[4] FDA. "Regulatory Status of Bisphosphonates." 2023.
[5] IMS Health. "Reimbursement and Policy Trends." 2023.
