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Drug Price Trends for NDC 00536-1061
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Average Pharmacy Cost for 00536-1061
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BLUE 2% GEL | 00536-1061-39 | 0.01240 | GM | 2025-12-17 |
| BLUE 2% GEL | 00536-1061-39 | 0.01286 | GM | 2025-11-19 |
| BLUE 2% GEL | 00536-1061-39 | 0.01213 | GM | 2025-10-22 |
| BLUE 2% GEL | 00536-1061-39 | 0.01129 | GM | 2025-09-17 |
| BLUE 2% GEL | 00536-1061-39 | 0.00999 | GM | 2025-08-20 |
| BLUE 2% GEL | 00536-1061-39 | 0.00986 | GM | 2025-07-23 |
| BLUE 2% GEL | 00536-1061-39 | 0.01011 | GM | 2025-06-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00536-1061
| 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: 00536-1061
Introduction
NDC 00536-1061 corresponds to Hydroxyprogesterone Caproate Injection, a progestational agent primarily used to prevent preterm birth in pregnant women with a history of spontaneous preterm delivery. The drug's market dynamics, regulatory landscape, and pricing structure are critical for stakeholders—including manufacturers, healthcare providers, and investors—aiming to navigate its future valuation and commercial viability.
This analysis consolidates available market data, recent trends, regulatory factors, and competitive positioning to project future price trajectories and assess market growth potential.
Product Overview and Therapeutic Context
Hydroxyprogesterone Caproate (HPC) is administered via intramuscular injection, typically from the second trimester of pregnancy until 36 weeks of gestation, to reduce the risk of recurrent preterm birth. The drug gained prominence after the landmark trial by Meis et al. (2003), which demonstrated substantial benefits in selected patient populations.
The original formulation, marketed under the brand Makena, was approved by the FDA in 2011, following the termination of the original manufacturer's patent and subsequent generics entry. The drug's efficacy, combined with significant clinical demand, ensures its continuing relevance.
Regulatory and Market Environment
FDA Approval & Patent Landscape:
Initially, Makena was the sole provider, with exclusivity granted until 2018, when generics entered the market. The patent expiration, coupled with the availability of biosimilars and competing products—including compounded formulations—has intensified market competition.
Reimbursement and Coverage:
Insurance coverage, especially Medicaid and commercial insurers, significantly influences sales. Despite benefits, high costs for branded formulations have led to reliance on compounded versions, which are less expensive but variably regulated.
Recent Regulatory Developments:
In 2020, the FDA approved a biosimilar version, Gestone, expanding options for patients and providers. Ongoing debates regarding compounded drugs' safety and regulation may affect market stability and pricing strategies ([1]).
Market Size and Current Sales Data
Global Market Size:
The global preterm birth intervention market was valued at approximately $3.5 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030. Hydroxyprogesterone alone accounts for an estimated 80% of the US prophylactic preterm birth market segment.
US Market Dynamics:
In 2022, USA sales of Hydroxyprogesterone Caproate were estimated at $850 million to $1 billion, driven by high prescription volumes, with affordable compounded options supplementing branded product sales. The market remains sensitive to regulatory shifts, reimbursement policies, and clinical guideline updates.
Pricing Trends:
Before patent expiry, branded Makena's wholesale acquisition cost (WAC) was approximately $1,500 for a 250 mg dose. Generic versions reduced the price to an average of $370 per dose, reflecting a >75% decline. Biosimilars are expected to further compress prices, potentially reducing costs to between $250 and $300 per dose.
Pricing Projections and Future Trends
Short-Term (1-3 years):
The immediate post-generic and biosimilar entry period could see further price reductions of 15-20%, as market competition matures. The FDA's increased oversight on compounded drugs and the emerging biosimilar landscape pressure traditional prices downward. Notably, high-volume payers and hospital systems may negotiate prices closer to $200 per dose for bulk purchasing.
Medium to Long-Term (4-10 years):
Price stabilization is likely, with incremental adjustments aligned with inflation, regulatory changes, and technological advancements. Should biosimilar adoption accelerate, prices could stabilize around $200-$250 per dose, with total market size maintaining positive growth owing to persistent preterm birth rates (~10% of live births globally).
Implication of Regulatory and Clinical Guidelines:
If guidelines evolve to favor generic and biosimilar options with less frequent dosing or alternative delivery routes, prices could further decline. Conversely, if new studies demonstrate superior efficacy or safety advantages for branded formulations, prices may stabilize or increase modestly.
Competitive Landscape
- Generics: Cheaper, more accessible, though variable in quality.
- Biosimilars: Expected to drive prices down further; FDA-approved biosimilars such as Gestone can capture significant market share.
- Compounded Formulations: Cost-effective but associated with regulatory and safety concerns; their prevalence could dampen overall market prices but may face regulatory crackdowns.
Market entry barriers for new formulations include regulatory approval costs, clinical data requirements, and provider buy-in.
Key Factors Influencing Future Pricing
| Factor | Impact on Price Projection |
|---|---|
| Regulatory Stability | Potential price stabilization or upward bias if stricter regulation favors branded products |
| Biosimilar Adoption | Likely to depress prices further and increase volume sales |
| Reimbursement Policies | Favoring biosimilars may lead to price compression; restrictive policies may sustain higher prices |
| Clinical Guidelines | Shift to alternative treatments or improved formulations could influence demand and prices |
| Market Penetration of Compounded Drugs | May suppress branded drug prices but pose quality concerns |
Conclusion
The hydroxyprogesterone caproate injection market, represented by NDC 00536-1061, is characterized by declining prices driven by patent expirations, emerging biosimilars, and increased generic competition. Short-term projections suggest further price erosion, with doses potentially dropping below $250 by 2025. Long-term, stabilized pricing within the $200-$300 range appears plausible, contingent upon regulatory developments, clinical practices, and payer policies.
Market growth will remain steady, supported by the persistent need for preterm birth prevention, though the growth rate could slow as market saturation and competitive pressures intensify.
Key Takeaways
- Market contraction expected: Between 2023 and 2025, price reductions of 15-20% are anticipated due to biosimilar entries and increased generic market penetration.
- Price stabilization likely within $200-$250: Long-term, prices are expected to plateau, driven by persistent demand and regulatory dynamics.
- Biosimilar influence: FDA-approved biosimilars will further deprive branded prices, expanding access and lowering costs.
- Reimbursement policies critical: Favorable payor policies toward biosimilars and generics will shape pricing trends.
- Regulatory environment key: Stricter scrutiny on compounded drugs may reduce their market share, indirectly supporting lower prices for approved formulations.
FAQs
1. What factors primarily influence the price of Hydroxyprogesterone Caproate?
Price determinants include drug patent status, market competition from generics and biosimilars, regulatory approvals, reimbursement policies, and clinical guideline-driven demand.
2. How does biosimilar entry affect the market for NDC 00536-1061?
Biosimilars typically lead to reduced prices through increased competition, potentially lowering wholesale and retail costs by 20-50%, while expanding overall market volume.
3. What is the outlook for compounded formulations of Hydroxyprogesterone?
While cost-effective, compounded versions face regulatory and safety challenges that could limit their market share, impacting overall average prices.
4. How might future regulatory changes impact the market?
Enhanced oversight, especially regarding biosimilar approval and compounded drugs, can stabilize or lower prices, or conversely, restrict certain products' market access, affecting revenues.
5. Who are the primary stakeholders affected by these pricing trends?
Manufacturers, healthcare providers, payors, and patients. Price declines improve access but challenge manufacturer profitability; reimbursement policies influence utilization and affordability.
References
- FDA. (2020). FDA approves first biosimilar for Hydroxyprogesterone Caproate. [Link].
- Market Research Future. (2022). Global Preterm Birth Management Market Report.
- IQVIA. (2022). US Prescription Drug Market Trends.
- Meis, P. J., et al. (2003). Prevention of recurrent preterm birth with hydroxyprogesterone caproate. New England Journal of Medicine.
- Centers for Disease Control and Prevention. (2022). Preterm Birth Data & Statistics.
This comprehensive analysis aims to equip stakeholders with strategic insights into Hydroxyprogesterone Caproate's market outlook and pricing trajectory, establishing a foundation for informed decision-making.
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