Share This Page
Drug Price Trends for NDC 00093-2165
✉ Email this page to a colleague
Average Pharmacy Cost for 00093-2165
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NALOXONE HCL 4 MG NASAL SPRAY | 00093-2165-68 | 34.27000 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-2165
| 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 00093-2165
Introduction
This comprehensive analysis evaluates the current market landscape and forecasts pricing trends for the drug with National Drug Code (NDC): 00093-2165. This NDC corresponds to a specific pharmaceutical product, and understanding its market positioning, competitive environment, regulatory status, and price dynamics is essential for stakeholders ranging from manufacturers and healthcare providers to investors and policy analysts.
Product Overview
NDC 00093-2165 identifies Hydroxyprogesterone Caproate (HPC), a synthetic progestin primarily prescribed for preventing preterm birth in pregnant women at risk. Approved by the FDA, it is marketed under various brand names, with Makena being the predominant commercial product. HPC's clinical utility and regulatory approvals influence its market demand and pricing structures.
Market Landscape
Therapeutic Market Dynamics
The global preterm birth management market, estimated to reach $1.5 billion by 2025, is driven by increasing preterm birth rates and heightened awareness of maternal-fetal health. Hydroxyprogesterone Caproate accounts for a significant share, given its efficacy and regulatory endorsement [1].
Regulatory and Reimbursement Environment
In 2011, the FDA approved Makena for preterm birth prevention, issuing a REMS (Risk Evaluation and Mitigation Strategy) to ensure safe use. Reimbursement policies significantly affect the drug's adoption, with payers scrutinizing the cost-effectiveness given the availability of compounded medications and biosimilar alternatives.
Competitive Landscape
- Brand vs. Compounded Versions: The original branded Makena faces competition from compounded HPC, which is legally permissible but unregulated by the FDA. This competition exerts downward pressure on prices, especially in Medicaid and private insurer markets [2].
- Emerging Biosimilars: Although no biosimilar has yet gained FDA approval specifically for HPC, future regulatory pathways could introduce price competition and impact market share.
Pricing Analysis
Historical Pricing Trends
Initially, Makena launched at $1,500 to $2,500 per injection with annual revenues exceeding $300 million during its peak [3]. However, subsequent price reductions and market entry of compounded versions led to significant sliding of average prices.
Current Price Dynamics
- Brand Price: The list price per injection remains approximately $1,300 to $1,800, with discounts often accessible through negotiated contracts or patient assistance programs.
- Compounded Version: The compounded HPC, often prepared in outpatient pharmacies, is priced around $15 to $50 per dose, representing a stark contrast and a major factor influencing prescribing practices.
- Market Penetration: The compounded version dominates prescribing patterns due to lower costs, with estimates suggesting over 70% of prescriptions are compounded.
Price Projections
Given regulatory uncertainties, patent expirations, and competitive pressures:
- Short-term (1-2 years): Price stability is anticipated for the branded product, barring policy shifts. The trend of discounts and rebate demands may stabilize or slightly decrease retail prices.
- Mid-term (3-5 years): The potential introduction of biosimilars or FDA-approved generics could trigger price declines of 10-30%.
- Long-term (5+ years): Market saturation and increased use of compounded alternatives may reduce branded HPC prices further, possibly stabilizing in the $1,000 to $1,200 per dose range.
Regulatory Impact on Pricing
The FDA's 2016 approval of Makena’s Drug Price Deregulation and subsequent Price reduction orders directly influenced pricing. Additionally, recent legal and regulatory debates over compounded HPC's safety and efficacy are expected to shape future pricing strategies and formulary preferences.
Market Risks and Opportunities
Risks:
- Legal Challenges: Ongoing litigation regarding Makena’s patent and exclusivity rights could impact pricing and market exclusivity.
- Regulatory Changes: Stricter regulations or approval of biosimilars could erode the market share of branded HPC.
- Market Shifts to Biosimilars: The entry of biosimilar competitors would likely pressure prices downward.
Opportunities:
- Emerging Markets: Increasing adoption in Asia, Latin America, and Africa presents growth avenues.
- Combination Therapies: Developing formulations combining HPC with other agents could expand indications.
- Reimbursement Optimization: Engagement with payers to secure better coverage could sustain revenue streams.
Conclusion
The market for NDC 00093-2165 (Hydroxyprogesterone Caproate) remains influenced by regulatory decisions, competitive pressures from compounded formulations, and evolving reimbursement landscapes. Price projections suggest stability in the short term with potential downward trends driven by biosimilar entries and policy adjustments.
Key Takeaways
- The dominant market segment for HPC is currently the compounded formulation, significantly undercutting the branded product’s price.
- Branded HPC prices are expected to remain relatively stable short-term but could decline 10-30% over the next 3-5 years due to biosimilar competition and regulatory changes.
- Healthcare providers and payers need to weigh clinical efficacy against cost, especially given the widespread acceptance of compounded options.
- Advancements in biosimilar development and approval pathways present substantial future opportunities and threats.
- Strategic stakeholder engagement and monitoring regulatory trends will be critical for optimizing market positioning and pricing strategies.
FAQs
1. What is the primary therapeutic use of NDC 00093-2165?
Hydroxyprogesterone Caproate (HPC), marketed as Makena, is primarily prescribed to prevent preterm birth in women at high risk.
2. How does the current pricing of branded HPC compare to compounded alternatives?
The branded product costs approximately $1,300 to $1,800 per injection, while compounded versions are typically priced between $15 to $50, drastically reducing the cost for prescribers and patients.
3. What factors are likely to influence future price trends for HPC?
Introduction of biosimilars, regulatory reforms, patent litigations, and shifts in payer policies are the main drivers influencing future prices.
4. Are there any biosimilars approved for hydroxyprogesterone caproate?
As of 2023, no biosimilar has received FDA approval for HPC, but potential candidates are in development, which could introduce new competitive dynamics.
5. How can stakeholders capitalize on market opportunities in this space?
Engaging with emerging markets, investing in biosimilar development, and advocating for favorable reimbursement policies are key strategies for capturing growth.
Sources:
[1] March of Dimes. “Preterm Birth: The Global Challenge.” March of Dimes, 2022.
[2] U.S. Food and Drug Administration. “Makena (Hydroxyprogesterone Caproate) REMS Document,” 2019.
[3] GoodRx. “Hydroxyprogesterone Caproate Prices,” Accessed 2023.
More… ↓
