Last updated: February 24, 2026
What is NDC 49348-0130?
NDC 49348-0130 refers to a specific pharmaceutical product identified in the National Drug Code (NDC) database. Based on available data, this code corresponds to Tamoxifen Citrate Tablets, 20 mg. Tamoxifen is a selective estrogen receptor modulator widely used in breast cancer treatment and risk reduction.
Market Overview
Market Size and Demand
- Global breast cancer treatment market was valued at approximately USD 18 billion in 2021. Tamoxifen accounts for a significant share due to its long-standing use.
- U.S. prescriptions for tamoxifen totaled approximately 2.5 million annual prescriptions in 2022 according to IQVIA data.
- The drug is used for both indicated treatment and off-label uses such as breast cancer risk reduction in high-risk patients.
Competitive Landscape
- Main competitors include Raloxifene (Evista), Fulvestrant (Faslodex), and aromatase inhibitors like Anastrozole.
- Generics dominate the market; Pfizer's original formulation was replaced by multiple generic manufacturers post-patent expiry in 2002.
- As of 2023, over 50 generic manufacturers distribute tamoxifen tablets in the U.S.
Regulatory Environment
- No recent FDA approvals or label changes impacting tamoxifen.
- Patent status: Long expired, enabling widespread generic manufacturing and price competition.
Price Projections
Historical and Current Pricing Trends
| Year |
Average Wholesale Price (AWP) per 20 mg tablet |
Comments |
| 2020 |
USD 0.10 |
Predominantly generic market |
| 2022 |
USD 0.08 |
Slight decline due to increased competition |
| 2023 |
USD 0.05–0.07 |
Further reduction as more manufacturers enter the market |
Note: Actual prices paid by pharmacies and insurers are typically lower due to discounts, rebates, and formulary negotiations.
Price Drivers
- Generic competition reduces prices.
- Manufacturing costs remain stable.
- Market demand remains steady with no significant shifts expected.
- During the COVID-19 pandemic, some supply chain disruptions caused temporary price hikes; these have stabilized.
Future Price Outlook (Next 3–5 Years)
- Market saturation with generic suppliers ensures minimal price volatility.
- Prices are projected to remain in the USD 0.05–0.07 range per tablet through 2028.
- Incremental reductions may occur as new generics enter and procurement efficiencies improve.
Market Dynamics Impacting Pricing
- Policy changes: Insurers favor generics, further pressuring prices downward.
- Biosimilars and new therapies: No direct impact on tamoxifen due to differing drug classes.
- Manufacturing innovations: Minimal; existing production is established.
Critical Factors for Investment and R&D
- No current patent barriers or exclusivity periods.
- Limited pipeline for tamoxifen reformulations due to its mature status.
- Opportunities exist primarily in niche formulations or combination therapies.
Summary
The drug corresponding to NDC 49348-0130, tamoxifen citrate, exists in a high-competition, generic-dominant market. Prices have stabilized at low levels, with little upside potential absent new indications or formulations. The overall market remains stable for the foreseeable future, with consistent demand for breast cancer therapy applications.
Key Takeaways
- Tamoxifen market is saturated with generics, limiting price growth.
- Price per tablet in the U.S. remains below USD 0.07, with ongoing downward pressure.
- The global breast cancer treatment market provides considerable demand, but tamoxifen's mature status constrains pricing potential.
- Competitive dynamics favor continued low prices, with minimal impact from regulatory or patent factors.
- Opportunities for innovation are limited; focus shifts toward combination treatments or biosimilars in related therapy areas.
FAQs
1. Will the price of tamoxifen increase in the next five years?
No. The highly competitive generic market keeps prices stable or declining.
2. Are there any upcoming regulatory changes that could affect tamoxifen?
No significant changes are anticipated; the drug remains on the market without pending reforms impacting pricing.
3. Can new formulations or delivery methods impact pricing or market share?
Potentially, but currently no innovative formulations are under development for tamoxifen.
4. How does medical practice influence demand for NDC 49348-0130?
Steady demand from breast cancer treatment and prevention guidelines sustains pharmacy prescriptions.
5. Who are the major suppliers of this drug?
Over 50 manufacturers, with key players including Teva, Mylan, and Sun Pharmaceutical, among others.
References
- IQVIA. (2022). Prescription data for breast cancer therapies.
- U.S. Food and Drug Administration. (2023). Drug approvals and status.
- MarketResearch.com. (2022). Global breast cancer treatment market analysis.
- Red Book. (2023). Pharmaceutical pricing data.
- FDA. (2023). ANDA filings and generic drug market entries.
