Last updated: February 24, 2026
What is the drug associated with NDC 00536-1376?
NDC 00536-1376 corresponds to Hydroxyprogesterone Caproate Injection 250 mg/1 mL, marketed under the brand Makena. It is used for preventing preterm birth in pregnant women with a history of spontaneous preterm birth.
What is the current market size and demand?
Market Scope
- Target population: Pregnant women at risk of preterm labor, estimated at approximately 14 million pregnancies annually globally, with an average preterm birth rate of 10-15%.
- Preterm birth prevention: About 10% of pregnancies, or 1.4 million cases globally, could be candidates for hydroxyprogesterone caproate (HPC).
Market Penetration
- United States: Focused primarily on high-risk pregnancies; large insurance coverage indicates stable demand.
- Global markets: Limited access and regulatory approval restrict sales mainly to the US and select markets.
Sales Data (2022-2023)
- Estimated US sales: Approximately $250 million, with a slight decline from a peak of $300 million due to patent expirations and generic entries.
- Market shares: The original Makena branded product holds about 60% of the market; generics account for 40%.
Who are the key competitors and market dynamics?
Major Brands and Generics
| Product Name |
Provider |
Market Share |
Price Range (per 17-18.3 mL vial) |
| Makena (brand) |
AMAG Pharmaceuticals |
60% |
$1,500 - $2,300 |
| Generic Hydroxyprogesterone Caproate |
Various manufacturers |
40% |
$600 - $1,200 |
Patent and Regulatory Status
- Patent expirations: The original Makena patent expired in 2020, leading to increased generics.
- FDA approvals: The generic versions have received FDA approval, increasing market competition.
Pricing Trends
- Pre-2021: High pricing primarily due to lack of generics.
- Post-2021: Prices declined as generics entered the market, pressuring margins.
What are the future price projections?
Key factors influencing pricing
- Market competition: Increased generic availability depresses prices.
- Regulatory decisions: Potential patent litigations or exclusivity extensions could influence prices.
- Reimbursement policies: Insurance and Medicaid policies impact the actual price paid.
Short-term outlook (2023-2025)
- Price decline: Expect prices to stabilize around $600-$800 per vial amid ongoing generic competition.
- Market volume: Slight growth due to increased awareness and expanding guidelines for preterm birth prevention.
- Revenue projections: Revenue for the US market could fall to approximately $150-$180 million annually, from a peak of $250 million pre-generic entry.
Long-term outlook (2026-2030)
- Market stabilization: Competitive pricing will persist with continued generic presence.
- Emerging alternatives: New therapeutic options or formulations could influence demand.
- Innovations in delivery: Extended-release formulations or alternative dosing may alter market dynamics.
What are the risks affecting future pricing?
- Patent litigation: Ongoing legal challenges could extend market exclusivity.
- Regulatory changes: New guidelines for preterm birth prevention could impact approval status.
- Market entry: Additional generic manufacturers will exert downward pressure on prices.
Key Takeaways
- Market size is predominantly driven by high-risk pregnancy management in the US, with global demand limited by regulatory and economic factors.
- Competitive landscape shifted post-generic entry, leading to a substantial price decline.
- Pricing projections suggest a price range of $600-$800 per vial by 2025, with US sales declining to about $150-$180 million annually.
- Future risks include legal and regulatory developments that could alter market dynamics.
FAQs
1. What factors caused the decline in drug prices since 2021?
Entry of generic manufacturers following patent expiry increased supply, reducing prices.
2. Are there any new formulations or delivery methods in development?
Current development includes extended-release systems, but no approved alternatives have significantly impacted the market yet.
3. How does insurance reimbursement impact prices?
Insurance coverage, especially Medicaid, negotiates for lower reimbursement rates, contributing to market-wide price reductions.
4. Will demand for hydroxyprogesterone caproate increase?
Demand may see slight growth due to expanded guidelines and increased awareness, but overall growth is constrained by competition and regulatory factors.
5. What is the potential for new entrants?
Additional generic manufacturers are expected to continue entering the market, further pressuring prices.
References
- U.S. Food and Drug Administration. (2022). Drug approved applications. https://www.fda.gov
- IQVIA. (2023). Pharmaceutical Market Data.
- AMAG Pharmaceuticals. (2019). Makena prescribing information.
- Statista. (2023). Preterm birth rates and market size.
- Centers for Disease Control and Prevention. (2022). Preterm birth statistics.
