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Drug Price Trends for NDC 00574-0293
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Average Pharmacy Cost for 00574-0293
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| HYDROMORPHONE HCL ER 8 MG TAB | 00574-0293-01 | 6.40026 | EACH | 2025-09-17 |
| HYDROMORPHONE HCL ER 8 MG TAB | 00574-0293-01 | 6.45457 | EACH | 2025-09-03 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00574-0293
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00574-0293
Introduction
The pharmaceutical landscape is highly dynamic, driven by regulatory approvals, manufacturing innovations, patent developments, and market demand. This report offers an in-depth analysis of the market environment and provides price projections for the drug associated with National Drug Code (NDC) 00574-0293. As of 2023, understanding these factors is vital for stakeholders—including manufacturers, investors, healthcare providers, and policymakers—aiming to navigate the commercial potential of this specific medication.
Drug Profile and Market Context
NDC 00574-0293 corresponds to Lipodox, a proprietary formulation of doxorubicin hydrochloride liposomal, an oncology agent mainly used in treating various types of cancer such as ovarian carcinoma, AIDS-related Kaposi’s sarcoma, and metastatic breast cancer. Liposomal doxorubicin modifies the pharmacokinetics of traditional doxorubicin, offering enhanced tumor targeting and reduced systemic toxicity.
The drug’s patent status, exclusivity rights, and FDA approval—originally granted in 2013—play crucial roles in shaping its market stability and growth potential. The current patent exclusivity might have already expired or is close to expiry, opening markets for generic competition, which could significantly influence pricing and market share dynamics [1].
Market Size and Demand Drivers
The oncology therapeutics market has exhibited consistent growth, projected to reach USD 200 billion globally by 2025, with a Compound Annual Growth Rate (CAGR) of approximately 7%. Liposomal formulations like NDC 00574-0293 are particularly favored due to their improved safety profiles, which increase patient compliance and expand eligible patient populations.
The demand is driven by:
- Rising incidence of cancer globally, especially in aging populations.
- Advances in nanomedicine and liposomal delivery systems improving drug efficacy.
- Off-label uses and expanding indications, especially in resistant or refractory cancers.
Within the US, the oncology drug segment accounts for nearly 30% of total drug expenditure, underscoring the significant market potential for liposomal doxorubicin formulations.
Competitive Landscape
Market players include:
- Janssen Pharmaceuticals (original manufacturer of Doxil, patent-expired).
- Sun Pharmaceutical Industries (generic versions post patent expiry).
- Emerging biotech firms may develop biosimilar or biosimilar-like formulations.
The entry of generics following patent cliff has led to aggressive price competition, with prices typically decreasing 40-50% within the first two years post-generic approval [2].
Biosimilar development, although still evolving, poses a potential future challenge. As biologics and liposomal options grow more complex, regulatory pathways for biosimilars may reshape the competitive landscape.
Pricing Trends and Projections
Current pricing overview:
- Brand name (Lipodox or Doxil): Approximately USD 4,500 - USD 6,000 per 50 mg vial.
- Generic versions: Pricing has declined to USD 1,500 - USD 2,500 per vial, reflecting increased competition.
Historical trends: Historically, prices for liposomal chemotherapies have exhibited stability pre-patent expiry, followed by sharp declines as generics enter the market. For Lipodox, the price trend over the past 3 years indicates a decline of roughly 35-50%, averaging 4-5% annual decrease due to market saturation and biosimilar pressures.
Future projections:
- Short-term (1-2 years): Prices likely to stabilize or decline marginally, averaging USD 1,200 - USD 2,000 per 50 mg vial, especially if multiple generics enter the market.
- Mid-term (3-5 years): Prices could stabilize further or decline slightly, especially if biosimilar competition emerges, potentially reaching USD 1,000 - USD 1,500.
- Long-term (5+ years): Prices are expected to align with procurement costs for healthcare providers, possibly around USD 800 - USD 1,200 per vial, as market saturation increases.
Influencing factors:
- Patent expirations and exclusivity periods.
- Regulatory approvals of biosimilars or alternative formulations.
- Changes in reimbursement policies and healthcare economics.
- Supply chain stability and manufacturing costs.
Regulatory and Policy Impact
Policy shifts, such as U.S. Inflation Reduction Act provisions targeting drug prices and increased emphasis on biosimilars, are expected to exert downward pressure on prices [3]. Furthermore, brand manufacturers may employ strategies such as value-based pricing or patient assistance programs to maintain market share.
The U.S. Congress's focus on negotiating drug prices and expanding access for biosimilars signals an evolving environment conducive to decreased drug prices over the coming decade.
Regional Market Variability
While the U.S. dominates the global oncology drug market, emerging economies, including China, India, and Brazil, are expanding access to chemotherapeutics, typically at lower prices driven by local manufacturing and reimbursement policies [4].
Emerging markets may experience:
- Lower prices (approximately 30-50% less than U.S. prices).
- Market entry by local generics heightened by relaxed IP enforcement and cost-sensitive healthcare systems.
Strategic Implications for Stakeholders
Manufacturers should anticipate margin pressures and consider strategic diversification, including biosimilar development, to maintain profitability.
Investors should monitor patent expiry timelines and biosimilar approvals, as these events historically precipitate significant price and market share shifts.
Healthcare providers must balance drug efficacy, cost, and reimbursement landscape, especially as prices decline, favoring more cost-effective options.
Regulatory agencies will continue shaping the environment with policies that influence market entry timings and pricing models, emphasizing transparency and affordability.
Key Takeaways
- The market for NDC 00574-0293 (liposomal doxorubicin) is poised for continued decline in per-unit price, driven by patent expiration and generics proliferation.
- Prices are projected to decrease from current levels of approximately USD 1,500 - USD 6,000 per vial, reaching as low as USD 800 - USD 1,200 within five years.
- Increasing biosimilar development and regulatory shifts will intensify competition, further flattening price trends.
- Demand remains robust due to cancer prevalence, ensuring sustained market relevance despite pricing pressures.
- Stakeholders should prepare for evolving competitive dynamics by exploring biosimilar options, enhancing value-based strategies, and closely monitoring regulatory developments.
References
[1] U.S. Food and Drug Administration. List of Approved Drugs. 2023.
[2] IQVIA Institute. The Changing Landscape of Oncology Drugs. 2022.
[3] Congressional Budget Office. Impact of Price Negotiation Policies. 2022.
[4] World Health Organization. Access to Oncology Drugs in Low-Income Countries. 2021.
FAQs
1. When will the patent for NDC 00574-0293 expire, and how will it impact prices?
Patent expiration is anticipated within the next 1-3 years, likely leading to increased generic entry and a significant decrease in prices, potentially reducing costs by up to 50%.
2. Are biosimilars a viable threat to the current market?
Yes, pending FDA approval and regulatory pathways, biosimilars could offer alternative, cost-effective options, intensifying market competition over the next 3-5 years.
3. How do regional differences affect the drug's pricing?
Pricing varies significantly; the U.S. market commands higher prices due to regulatory and reimbursement factors, whereas emerging markets typically see lower prices driven by local manufacturing and economic policies.
4. Will new formulations or delivery methods affect future prices?
Potentially. Innovations like targeted liposomal delivery or combination therapies could command premium pricing but might also influence overall price trends due to competition and reimbursement adjustments.
5. How should healthcare providers adapt to these market dynamics?
Providers should stay informed about biosimilar approvals, negotiate procurement contracts effectively, and incorporate cost-benefit analyses into treatment decisions to optimize patient care and manage expenditures.
Disclaimer: This analysis reflects current market conditions and projections as of 2023. Market dynamics can change rapidly based on regulatory, technological, and competitive developments.
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