Last updated: February 22, 2026
What Is NDC 00781-5578?
NDC 00781-5578 refers to a specific formulation of a drug registered with the National Drug Code system. Based on available public data, NDC 00781-5578 is identified as Hydroxyprogesterone caproate injection, commonly used for preventing preterm birth in pregnant women.
Market Overview
Indications and Usage
Hydroxyprogesterone caproate injection is indicated for:
- Prevention of recurrent preterm birth in women with a history of spontaneous preterm birth.
- Occasionally used off-label for other reproductive health indications.
Market Size and Demand
The US preterm birth rate is approximately 10.5% as of 2022, with around 400,000 preterm births annually. The demand for hydroxyprogesterone caproate primarily aligns with this rate, with an estimated 50% of women at risk receiving treatment.
- Estimated annual prescriptions: 200,000 – 250,000 units
- Market penetration: Limited to obstetric practices, primarily specialists
Competitive Landscape
- Brand Name: Makena (marketed by therapeutics companies like Commonwealth Quality Diabetes Care)
- Generic Versions: Several generics entered the market following patent expiry in 2020.
- Market Share: Brand formulary accounts for >60%, with generics rapidly gaining usage.
Pricing Dynamics
Current Price Points
- Brand Makena: $1,800 – $2,000 per injection (single-dose vial)
- Generic Hydoxyprogesterone Caproate: $900 – $1,200 per dose
Prices depend on distribution channels, with negotiated PBM discounts and payer contracts influencing actual transaction prices.
Cost Components
- Manufacturing costs: Estimated at $50–$100 per dose
- Regulatory compliance and quality control: Adds to expenses but is standard across sterile injectable drugs
- Market access costs: Impact pricing, especially with increasing generic competition
Price Projections
Short-Term (Next 1-2 Years)
- Stability expected in brand pricing, around $1,800–$2,000 per dose.
- Generics may see price erosion due to increased competition; anticipated prices: $700–$1,000.
Medium to Long-Term (3-5 Years)
- Pricing decline for generics likely to plateau around $500–$800 per dose.
- Market volume adjustments: May decrease if alternative therapies or delivery methods reduce demand.
- Potential for price stabilization if new formulations or delivery systems are introduced.
External Factors Impacting Prices
- Reimbursement policies: Increased payer scrutiny could pressure prices downward.
- Regulatory approvals: New formulations or biosimilars could influence market share and pricing.
- Insurance coverage: Widespread coverage could sustain higher prices temporarily.
Risks and Opportunities
| Risks |
Opportunities |
| Increased generic competition |
Expansion into new markets or indications |
| Regulatory challenges |
Developing long-acting formulations |
| Shifts in obstetric practices |
Price stabilization through brand loyalty |
Key Takeaways
- NDC 00781-5578 is hydroxyprogesterone caproate injection, a treatment for preventing preterm birth.
- The product’s market is primarily driven by obstetric indications, with a demand of roughly 200,000–250,000 doses annually.
- Brand prices are around $1,800–$2,000 per dose; generics are priced at $700–$1,200, with expected decline over the next few years.
- Market volume could slow due to alternative therapies, but demand remains substantial.
- Price erosion is likely as generic competition intensifies, but market stability may occur with new delivery systems.
FAQs
1. How does patent expiration affect the drug’s price?
Patent expiration allows generic manufacturers to enter the market, increasing competition and reducing prices over time.
2. What are the main factors influencing current market demand?
Preterm birth rates, obstetric guidelines, and payer reimbursement policies drive demand.
3. Are there any upcoming regulatory changes that could affect pricing?
Potential approvals of biosimilars or new formulations could impact market dynamics and pricing.
4. How does insurance coverage influence the actual price paid?
Insurance negotiations and rebates significantly reduce the out-of-pocket costs for patients and influence actual transaction prices.
5. Are there development trends in this therapeutic area?
Yes, efforts are ongoing to develop long-acting formulations and alternative delivery methods to improve treatment adherence and outcomes.
References
- Centers for Disease Control and Prevention. (2022). Preterm Births in the United States. CDC Reports.
- IQVIA. (2022). National Drug Trends and Pricing Data.
- FDA. (2020). Approval and Labeling of Hydroxyprogesterone Caproate.
- GoodRx. (2023). Hydroxyprogesterone Caproate Prices.
- Wolters Kluwer. (2023). Pharmaceutical Market Reports.
