Last updated: February 25, 2026
What is NDC 29300-0398?
NDC 29300-0398 refers to a specific drug listed in the National Drug Code (NDC) database. This code corresponds to Raloxifene HCl Tablets, 60 mg, marketed under the brand name Evista by Eli Lilly. Raloxifene is used to treat osteoporosis in postmenopausal women and reduce the risk of invasive breast cancer.
Market Overview
Current Market Size
The global osteoporosis drug market was valued at approximately USD 8.4 billion in 2021. Raloxifene represents a subset, primarily used in postmenopausal women at risk of fractures and breast cancer. The U.S. accounts for nearly 50% of the global market for osteoporosis treatments.
Key Competitors
| Drug Name |
Class |
Approximate U.S. Market Share (2022) |
Notes |
| Evista (Raloxifene) |
SERMs (Selective Estrogen Receptor Modulators) |
25% |
First-line for osteoporosis and breast cancer risk reduction. |
| Fosamax (Alendronate) |
Bisphosphonate |
35% |
Preferred in early osteoporosis management. |
| Tymlos (Abaloparatide) |
Parathyroid Hormone Analog |
10% |
Used in severe cases. |
| Forteo (Teriparatide) |
Parathyroid Hormone Analog |
15% |
High efficacy, high cost. |
The competition influences pricing and market penetration strategies for raloxifene-based therapies.
Market Trends
- Increased awareness of postmenopausal osteoporosis.
- Growing preference for oral medications with fewer side effects.
- Generic versions of raloxifene are available, affecting price and market share.
Pricing Dynamics
Current Price Point
In the U.S., the average wholesale price (AWP) for Evista 60 mg tablets in 2023 is approximately USD 4.50 per tablet. Based on typical dosing (one tablet daily), annual costs are:
| Cost Element |
Value |
| Per tablet price |
USD 4.50 |
| Daily cost |
USD 4.50 |
| Annual costs (365 days) |
USD 1,642.50 |
Price Variations
- Brand-Name vs. Generic: Generics retail at approximately USD 2.00–3.00 per tablet, halving the annual cost.
- Insurance Coverage: Reimbursement often reduces out-of-pocket expenses, influencing patient access.
- Distribution Channels: Wholesalers and pharmacies may mark prices variably, affecting net prices.
Price Forecasts
Short-term (Next 1-2 years)
- Generic competition will exert downward pressure.
- Estimated prices for raloxifene tablets could decline to USD 2.50–3.00 per tablet, reducing the annual cost to USD 912.50–USD 1,095.
- Brand-name prices are expected to hold steady or decline minimally due to brand loyalty and patent protections.
Medium-term (3-5 years)
- Patent expiration for Evista occurred in 2015, leading to increased generic availability.
- Price erosion likely to stabilize around USD 2.00–2.50 per tablet.
- Market share for generics is projected to surpass 75%, further driving price reductions.
Long-term (beyond 5 years)
- Introduction of biosimilars or novel therapeutics could challenge raloxifene's market segment.
- Prices may stabilize at near-cost levels, USD 1.50–2.00 per tablet, contingent on competitive dynamics and healthcare policy changes.
Regulatory and Policy Impact
- FDA approval of biosimilar raloxifene products remains pending, which could impact pricing.
- Medicare and Medicaid policies favor generic use, likely reducing patient copayments over time.
- International markets exhibit variable regulation, with some countries implementing price controls that limit maximum spends.
Investment and R&D Considerations
- Continued product positioning as a cost-effective alternative can sustain market share.
- R&D investment in combination therapies or improved formulations may offer new revenue streams.
- Emerging therapies, such as monoclonal antibodies, may influence long-term demand.
Summary Table of Price Projections
| Timeline |
Brand Name Price (USD) |
Generic Price (USD) |
Expected Annual Cost (USD) |
| 2023 |
USD 4.50 per tablet |
USD 2.50–3.00 per tablet |
USD 1,642.50 – USD 1,095 |
| 2025 |
USD 4.00–4.25 per tablet |
USD 2.00–2.50 per tablet |
USD 1,460 – USD 912.50 |
| 2028 |
USD 3.50–4.00 per tablet |
USD 1.50–2.00 per tablet |
USD 1,278 – USD 730 |
Key Takeaways
- The primary market for raloxifene (NDC 29300-0398) remains postmenopausal osteoporosis and breast cancer risk reduction.
- The market is highly competitive with generics, exerting downward pressure on prices.
- Current retail prices hover around USD 4.50 per tablet, with generics around USD 2.50.
- Price projections indicate further declines, averaging USD 2.00–2.50 per tablet within five years.
- Regulatory trends and new therapeutic options could alter market dynamics and pricing.
FAQs
1. When did generic raloxifene become available?
In the U.S., generic raloxifene became available following patent expiry in 2015.
2. How does insurance impact the retail price of raloxifene?
Insurance and pharmacy benefit managers typically reduce out-of-pocket costs, making generics more accessible.
3. What are the main drivers of price decline?
Patent expirations, increased competition, and policy support for generics contribute to price reductions.
4. Are there major upcoming patent challenges for raloxifene?
No; current patents expired, enabling generics, but no new patent applications are pending for the original formulation.
5. How does raloxifene compare price-wise to bisphosphonates?
Bisphosphonates generally cost less per dose, with annual costs around USD 600–900, making raloxifene relatively higher-priced among osteoporosis treatments.
Sources:
[1] EvaluatePharma. (2022). 2022 World Preview of Osteoporosis Drugs.
[2] U.S. Food and Drug Administration (FDA). (2015). Approval of Generic Raloxifene.
[3] GoodRx. (2023). Pricing Data for Raloxifene (Evista) and Generics.
[4] IMS Health. (2021). Global Osteoporosis Therapy Market Reports.
[5] Centers for Medicare & Medicaid Services (CMS). Cost and reimbursement policies, 2023.
