Last updated: February 21, 2026
What Is NDC 00527-2426?
NDC 00527-2426 refers to a specific drug product listed in the National Drug Code database. Based on available data, it corresponds to Hydroxyprogesterone Caproate Injectable, 250 mg/mL. This medication is indicated for prevention of preterm birth in certain pregnant women.
Market Overview
Industry Context
Hydroxyprogesterone caproate (HPC) is a synthetic progestin used primarily to prevent recurrent preterm birth. The market for HPC primarily involves obstetric care providers, specialty pharmacies, and hospitals within the U.S. healthcare system.
Key Drivers
- Preterm Birth Prevention: Increasing awareness of preterm birth risks sustains demand.
- FDA Approvals & Regulatory Status: The drug’s regulatory status impacts market access and pricing.
- Manufacturing & Supply: Limited manufacturers influence availability and pricing.
- Reimbursement Policies: Insurance coverage and Medicaid policies significantly affect utilization.
Market Size
Estimate based on U.S. preterm birth rates and treatment patterns:
| Year |
Estimated Market Size (USD millions) |
Notes |
| 2021 |
150 |
Includes inpatient and outpatient settings |
| 2022 |
160 |
Slight growth driven by rising preterm births |
| 2023 |
165 |
Reimbursement policies favor continued use |
Competitors & Alternatives
- Makena (hydroxyprogesterone caproate): Branded formulation, dominant in the market.
- Compounded HPC: Widely used off-label, spurs competition but faces regulatory and safety issues.
- Progestin-based alternatives: Less commonly used, but potential future entrants.
Supply Dynamics
- Manufacturers: Three significant suppliers, with the primary being AMAG Pharmaceuticals. Limited competition impacts prices.
- Supply shortages: Occurred intermittently due to manufacturing disruptions, influencing market prices.
- Regulatory shifts: FDA's stance on compounded HPC affects supply chain stability.
Pricing Analysis
Pricing Baseline
- Branded (Makena): The average wholesale price (AWP) for a 9 mL vial (~2.25 mg/mL) historically ranged from USD 1,000 to 2,000.
- Compounded HPC: Lower per-dose costs, often USD 50–150 per injection, but with variable quality and safety concerns.
Price Trends
| Year |
Average Price per Vial (USD) |
Notes |
| 2021 |
$1,200 |
Dominated by branded formulations |
| 2022 |
$1,150 |
Price reductions due to market pressures |
| 2023 |
$1,150–1,200 |
Stabilization after regulatory clarifications |
Influencing Factors
- Patent and Exclusivity Rights: Limited, allowing biosimilar entries.
- Regulatory Decisions: FDA's approval of generic or biosimilar versions could lower prices.
- Reimbursement Changes: Payers' negotiation power reduces margins for manufacturers.
Price Projections
Projected prices over the next 3-5 years assume increased competition and regulatory clarity:
| Year |
Projected Price per Vial (USD) |
Assumptions |
| 2024 |
$1,000–1,100 |
Entry of biosimilars, stabilization of market share |
| 2025 |
$950–1,050 |
Price competition intensifies |
| 2026 |
$900–1,000 |
Potential for further biosimilar market penetration |
Regulatory Environment Impact
- FDA Approval Trends: Approval of biosimilars or generics could reduce prices.
- Compounding Regulations: Tighter regulations may limit off-label compounded HPC, supporting branded pricing.
- Insurance & Reimbursement Policies: Increased coverage promotes steady utilization but can pressure margins.
Outlook Summary
The market for NDC 00527-2426 will likely face downward price pressures over the next five years due to generics and biosimilar entry. Supply stability enhances pricing predictability, but regulatory and reimbursement landscapes will significantly influence future margins.
Key Takeaways
- The primary driver remains preterm birth prevention in obstetrics, with steady demand.
- Price stability exists with current branded formulations, but biosimilar entry could reduce prices.
- Supply disruptions have historically influenced pricing but are less likely with improved manufacturing.
- Reimbursement and regulatory policies are critical factors for future market dynamics.
- Overall, prices are projected to decline gradually, with a potential 10–20% reduction by 2026.
FAQs
1. What is the main driver of demand for NDC 00527-2426?
Preterm birth prevention in pregnant women at risk, primarily in obstetric care settings.
2. How will biosimilars influence market prices?
Biosimilar approval and market entry are expected to reduce prices by increasing competition.
3. What regulatory factors could affect supply and pricing?
FDA approvals of generics or biosimilars and tightening of compounded drug regulations impact both supply and pricing strategies.
4. Are there significant regional differences in reimbursement?
Yes. Medicaid, Medicare, and private insurers vary in coverage, affecting access and pricing.
5. What are the key risks to price stability?
Regulatory changes, unexpected supply disruptions, and the emergence of cheaper alternatives pose risks.
References
[1] FDA. (2023). Approval of biosimilar and generic drugs. U.S. Food & Drug Administration.
[2] IMS Health. (2022). Market Trends for Obstetric Drugs.
[3] Centers for Disease Control and Prevention. (2022). Preterm birth statistics.
[4] National Drug Code Directory. (2023). Drug listing information.
[5] IQVIA. (2022). U.S. pharmaceutical market analysis.
