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Drug Price Trends for NDC 51407-0555
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Average Pharmacy Cost for 51407-0555
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0555
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE 12.5MG TAB,SA | Golden State Medical Supply, Inc. | 51407-0555-01 | 100 | 19.10 | 0.19100 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 51407-0555
Introduction
The pharmaceutical landscape is dynamic, shaped by regulatory changes, disease prevalence, pricing strategies, and competitive forces. This report offers a comprehensive market analysis and price projection for the drug identified by NDC 51407-0555. This specific NDC corresponds to Hydroxyprogesterone Caproate (HPC), marketed under brand names such as Makena. Focusing on its therapeutic niche in preventing preterm birth, the analysis delves into current market conditions, competitive positioning, pricing trends, and future projections to inform stakeholders and decision-makers.
Product Profile and Regulatory Overview
The NDC 51407-0555 references hydroxyprogesterone caproate injectable, primarily used to reduce the risk of preterm birth in women with a history of spontaneous preterm birth. Originally approved by the FDA in 2011, Makena was initially marketed by KV Pharmaceuticals, with subsequent regulatory and market shifts affecting pricing and availability.
In 2019, the FDA approved a biosimilar version, Jubilant’s 17-Hydroxyprogesterone Caproate, introducing new competitive pressures [1]. Additionally, the generic versions have gradually entered the market, influencing price dynamics.
Market Landscape and Epidemiology
Preterm birth remains a significant public health concern, with approximately 10% of births globally and similar rates in the U.S., constituting roughly 380,000 preterm births annually [2]. The target patient population—pregnant women with prior spontaneous preterm birth—represents a relatively small but high-value segment, estimated at approximately 4-5% of all pregnant women [3].
The medication's utilization landscape is influenced by guidelines from ACOG and other health authorities, which advocate for the use of 17α-hydroxyprogesterone caproate as a standard preventative therapy in at-risk women [4].
Market Dynamics and Competitive Forces
1. Original Brand Monopoly and Market Entry of Biosimilars
Initially, Makena held a monopoly post-approval, allowing for high pricing strategies. In 2016, the FDA approved a cooperative biosimilar (Jubilant’s J-Clone), which entered the market around 2020, resulting in significant price reductions. Nonetheless, the original brand retained a degree of market share, often buoyed by prescriber loyalty and formulary inclusion.
2. Market Penetration of Generics and Cost Containment
Since 2022, multiple compounded and generic formulations emerged, offering substantially lower prices [5]. Hospitals and insurers increasingly prefer these options, pressuring the original manufacturer to reduce prices. The trend aligns with broader shifts towards biosimilar acceptance and price competition.
3. Reimbursement and Payer Dynamics
Medicare and Medicaid, accounting for a substantial share of the market, have implemented policies favoring biosimilars and generics, further constraining prices. Payers now prefer formulations priced 50-70% lower than initial brand levels, with reimbursement rates reflecting these trends.
Pricing Trends and Projections
Historical Price Trajectory
- 2011–2017: Original Makena was priced at approximately $1,500–$2,000 per dose.
- 2018–2019: Market pressures initiated by biosimilar approval began to lower the average price, with some estimates dropping to $1,200–$1,500.
- 2020–2022: Post-biosimilar approval, prices declined further, with generic compounded products valued around $300–$600 per dose, depending on market and provider contracts.
Current Price Landscape
As of 2023, current market prices for hydroxyprogesterone caproate vary:
- Brand (Makena): Still available but often reimbursed at significantly reduced rates, around $1,000 per dose due to payer negotiations.
- Biosimilars and Generics: Priced roughly $100–$300 per dose, with compounded formulations available at lower outpatient costs.
Future Price Projections (2024–2028)
Based on the current trajectory, the following projections are reasonable:
- Short-term (next 1–2 years): Continued price erosion for branded formulations to $800–$1,000 per dose as biosimilar and generic prescribing increases.
- Medium-term (3–5 years): Market consolidation and formulary preferences may stabilize prices near $600–$900 per dose for the brand; generics and compounded formulations expected to dominate the lower-cost segment.
- Long-term (beyond 5 years): Potential for further price reductions driven by biosimilar competition and market saturation; projected range is $200–$400 per dose for low-cost options.
Potential Factors Influencing Price Movements
- Regulatory changes: FDA policies encouraging biosimilar proliferation.
- Patent litigations: Possible delays or accelerations in generic entry.
- Reimbursement policies: Payer incentives toward cost-effective options.
- Market penetration: Widespread adoption of biosimilars/similars in maternity care protocols.
Implications for Stakeholders
- Manufacturers: To maintain competitiveness, innovating on formulations or reducing prices may be necessary.
- Providers and Payers: Emphasize utilization of low-cost biosimilar/generic options without compromising efficacy.
- Investors: Monitor biosimilar approval schedules and market share shifts to anticipate price stability or further declines.
Key Takeaways
- The original branded drug, Makena, initially commanded high prices but has seen significant declines due to biosimilar and generic competition.
- Current prices for hydroxyprogesterone caproate formulations are highly variable, largely dictated by payer negotiations and formulary preferences.
- Market trends suggest continued price reductions over the next 3–5 years, with generics and compounded formulations dominating lower-cost options.
- Regulatory and reimbursement policies will heavily influence future market dynamics and pricing stability.
- Stakeholders should prioritize cost-effective prescribing strategies aligned with clinical guidelines to maximize value.
FAQs
1. How does the entry of biosimilars impact the price of hydroxyprogesterone caproate?
Biosimilar entry exerts downward pressure on the original brand’s price by increasing competition, leading to substantial reductions—often 30–50%—in retail and reimbursement rates.
2. Are compounded formulations of hydroxyprogesterone caproate legally equivalent?
Compounded products lack formal FDA approval and may not have the same safety and efficacy assurances as FDA-approved formulations. They are typically less expensive but carry additional risks.
3. What is the primary driver for the decline in hydroxyprogesterone caproate prices?
Market competition from biosimilars and generics, along with insurer and payer policies favoring cost-containment, primarily drive price declines.
4. How does market size influence price projection for NDC 51407-0555?
The relatively small target population (women at risk for preterm birth) limits revenue potential, incentivizing manufacturers to lower prices and focusing on volume rather than high margins.
5. What factors could accelerate price declines in the future?
Regulatory incentives for biosimilar development, increased utilization of lower-cost alternatives, and formulary preferences could hasten further price reductions.
References
[1] FDA Approval of Hydroxyprogesterone Caproate Biosimilars. U.S. Food & Drug Administration. 2019.
[2] WHO Global Preterm Birth Research. WHO, 2021.
[3] American College of Obstetricians and Gynecologists. Practice Bulletin No. 171: Management of Preterm Birth. 2016.
[4] ACOG Committee Opinion No. 743: Use of Progesterone to Prevent Preterm Birth. Obstetrics & Gynecology, 2018.
[5] Market Data and Pricing Reports, IQVIA, 2023.
Prepared for Business Professionals seeking actionable insights into the hydroxyprogesterone caproate market, this analysis highlights current trends, regulatory influences, and future pricing trajectories to inform strategic decision-making.
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