Last updated: February 23, 2026
What is NDC 00168-0163?
NDC 00168-0163 is a formulation of Raloxifene Hydrochloride, indicated for the prevention and treatment of osteoporosis in postmenopausal women. It is marketed under the brand name Evista by Eli Lilly and Company. The drug is available in 60 mg tablets.
Market Landscape
Market Size and Growth
- The global osteoporosis drugs market was valued at approximately USD 13.2 billion in 2021.
- Expected CAGR (Compound Annual Growth Rate) of 3.5% from 2022 to 2030 [1].
- The U.S. remains the largest market, accounting for roughly 40% of global sales.
Key Market Drivers
- Aging population in developed countries.
- Increasing awareness of osteoporosis.
- Off-label uses, such as breast cancer risk reduction.
- Patent expirations of competing drugs, increasing generic penetration.
Competitive Environment
Main competitors include:
| Drug Name |
Manufacturer |
Formulation |
Market Share (2022) |
Patent Status |
| Evista (Raloxifene) |
Eli Lilly |
60 mg oral tablets |
25% |
Patent expired (2016; generics available) |
| Fosamax (Alendronate) |
Merck |
70 mg weekly |
30% |
Patent expired (2011) |
| Tymlos (Abaloparatide) |
Radius Health |
80 mcg daily injection |
5% |
Patent valid until 2024 |
| Forteo (Teriparatide) |
Eli Lilly |
20 mcg daily injection |
10% |
Patent expired (2020) |
Generic versions of raloxifene entered the market after patent expiration, reducing prices.
Price Trends and Projections
Current Price Points
- Brand (Evista): Approximately USD 300–350 for a 30-day supply (60 mg daily dose).
- Generic raloxifene: USD 50–100 per 30-day supply.
Price Drivers
- Patent expiry led to significant price reduction.
- Insurance reimbursement policies influence retail pricing.
- Regulatory decisions may impact drug availability and pricing.
Projected Price Changes (2023-2028)
| Year |
Brand Price (USD) |
Generic Price (USD) |
Key Influences |
| 2023 |
300–350 |
50–100 |
Increased generic competition; biosimilars entering |
| 2024 |
250–330 |
40–90 |
Market saturation; reimbursement negotiations |
| 2025 |
230–310 |
35–80 |
Healthcare cost containment policies |
| 2026 |
200–290 |
30–70 |
Expansion into emerging markets; increased biosimilar options |
| 2027 |
180–270 |
25–65 |
Patent expiration for remaining formulations |
Market Revenue Projections
- 2023: USD 720 million.
- 2025: USD 580 million.
- 2028: USD 500 million.
Declines driven by routine generic substitution, shifting away from brand-name prescriptions.
Regulatory and Policy Environment
- FDA approved genertic raloxifene in 2016.
- State and federal reimbursement policies favor generics.
- Non-manufacturer patient assistance programs impact affordability.
Strategic Recommendations
- Limited pricing power for brand (Evista) due to patent expiration.
- Focus on generic market share expansion.
- Invest in biosimilar development for related therapies.
- Monitor regulatory changes affecting osteoporosis therapies.
Key Takeaways
- NDC 00168-0163’s market is mature, with a sizeable shift to generics.
- Prices are decreasing; anticipated to stabilize at lower levels.
- Revenue declines expected through 2028 due to market saturation.
- Competitive landscape favors cost-effective generics over brand name.
- Biosimilar and biosimilar-adjacent markets may present new opportunities.
FAQs
1. How has patent expiration affected NDC 00168-0163’s market?
Patent expiration in 2016 led to generic versions, reducing prices by approximately 70%. Brand sales declined accordingly.
2. What are the main competitors to raloxifene in osteoporosis treatment?
Main competitors include bisphosphonates like alendronate (Fosamax), injectable agents like teriparatide (Forteo), and other selective estrogen receptor modulators (SERMs).
3. Are biosimilars relevant for raloxifene?
No, raloxifene is a small molecule drug and not a biosimilar candidate. Biosimilar development pertains to biologics.
4. What factors could stabilize prices after the projected decline?
Regulatory protections, limited patent extensions, and reimbursement policies influence stabilization.
5. How does the aging demographic impact the market?
An aging population maintains demand for osteoporosis therapies; however, price sensitivity and generics impact revenue growth.
References
[1] Grand View Research. (2022). Osteoporosis Drugs Market Size, Share & Trends Analysis.
[2] FDA. (2016). Approval letter for generic raloxifene.
[3] IQVIA. (2022). US Prescription Data.
[4] MarketWatch. (2023). Pharmaceutical Price Trends.
[5] EvaluatePharma. (2022). Oncology and osteoporosis drugs market report.
