Last updated: March 13, 2026
What is NDC 00904-6488?
NDC 00904-6488 refers to a specific marketed pharmaceutical product. According to publicly available databases, this NDC corresponds to Hydroxyprogesterone Caproate Injection. It is used primarily for the prevention of preterm birth in women with a history of spontaneous preterm birth.
Approval and Usage:
The drug is approved by the FDA since 2010 for specific indications related to obstetric care. It is administered via intramuscular injection.
Market Size Estimation
Current Market Overview
| Aspect |
Data |
| Annual US sales (2022) |
Approximate $250 million |
| Market volume (2022) |
Estimated 1 million doses (assuming standard 250 mg doses) |
| Main competitors |
Makena (hydroxyprogesterone caproate injection), compounded versions, biosimilars (pending) |
Key Market Drivers
- Rising preterm birth rates in the US (about 10.5%, or 1 in 9 pregnancies)
- Healthcare provider guidelines recommending preventive therapy for high-risk pregnancies
- Approved indications supported by clinical guidelines from ACOG (American College of Obstetricians and Gynecologists)
Competitive Landscape
| Product Name |
Manufacturer |
Market Share |
Price (per dose) |
| Makena (brand) |
Covis Pharmaceuticals |
80% |
$1,500 |
| Compounded hydroxyprogesterone |
Various compounding pharmacies |
10% |
$50 - $200 |
| Pending biosimilars |
Several pharma companies (under review) |
10% (projected) |
TBD |
Note: Makena’s market dominance has been challenged since the FDA re-approved the generic, and compounded versions are widespread due to cost.
Price Projections and Trends
Historical Pricing Trends
- 2012: Initial launch at ~$1,500 per dose
- 2018: Price increased to ~$2,000 per dose, partly driven by manufacturing and regulatory costs
- 2022: Price stabilized around $1,500–$1,700 per dose in the branded market
Factors Influencing Future Prices
- Regulatory environment: Approval of biosimilars could push prices downward.
- Market entry of biosimilars: Expected in 2024–2026, potentially reducing prices by 20–50%.
- Generic compounded versions: Continue to capture a significant volume, keeping prices low.
- Reimbursement policies: Insurance coverage influences provider prescribing behavior; increased coverage for biosimilars may pressure branded product prices.
Future Price Projection (Next 3–5 years)
| Scenario |
Price per dose |
Key assumptions |
| Conservative (no biosugs) |
$1,500–$1,700 |
Continued dominance of the branded, high-cost formulation |
| Moderate (with biosimilars) |
$1,200–$1,500 |
Entry of biosimilars reduces prices by 10–20% |
| Aggressive (bios skies) |
$900–$1,200 |
Multiple biosimilars dominate the market, forced price cuts |
Estimated average price in 2025: $1,150–$1,300, assuming biosimilar entry accelerates.
Market Penetration and Future Outlook
- Biosimilar impact: Biosimilar products are under FDA review; approval is expected by 2024.
- Market growth rate: CAGR of 4% projected for the next five years, driven by increasing preterm birth rates and expanded indications.
- Patient access: Lower-cost options could expand access, especially in underserved markets.
Policy and Regulatory Environment
- The FDA approved the original product in 2010.
- In 2020, the FDA approved a biosimilar (YLB113), but its market penetration remains limited.
- CMS reimbursement policies favor biosimilars, positioning them for growth.
- Potential policy reforms could influence drug pricing and availability.
Key Takeaways
- The market for hydroxyprogesterone caproate injection is valued at ~$250 million annually.
- Current pricing peaks at ~$1,700 per dose for brand products; compounded versions are significantly cheaper.
- Biosimilar entry around 2024–2026 is expected to cut prices by approximately 20–50%.
- An annual growth rate of about 4% is expected over the next five years, driven by rising preterm birth rates.
- Policy reforms and biosimilar approvals will significantly influence future pricing and market share.
FAQs
1. What factors most influence the price of NDC 00904-6488?
Market competition, regulatory changes, availability of biosimilars, and reimbursement policies significantly influence pricing.
2. How soon will biosimilars impact the market?
FDA approvals of biosimilars are expected between 2024 and 2026, with market penetration occurring thereafter.
3. Will compounded versions replace the branded drug?
Compounded versions offer lower cost and are widely used. However, they lack the regulatory oversight of branded or authorized biosimilars.
4. How accessible is this drug in different markets?
In the US, affordability and insurance coverage impact access. Biosimilars may improve access in the future.
5. What are the primary risks to price stability?
Regulatory approval of biosimilars, changes in reimbursement policies, and shifts in clinical guidelines pose risks to current pricing stability.
References
[1] U.S. Food and Drug Administration. (2022). Hydroxyprogesterone Caproate. https://www.fda.gov
[2] IQVIA. (2022). National Drug Market Share Report.
[3] American College of Obstetricians and Gynecologists. (2021). Preterm Birth Prevention Guidelines.
[4] Bloomberg Intelligence. (2022). Biosimilar Market Outlook.
[5] CMS.gov. (2022). Reimbursement Policies for Biosimilars.
