Last updated: March 3, 2026
What is NDC 00591-0404?
NDC 00591-0404 identifies a specific pharmaceutical product—Hydroxyprogesterone Caproate (marketed as Makena). It is used to prevent preterm birth in pregnant women with a history of spontaneous preterm birth.
Market Size and Demand
Current Usage and Patient Population
- Estimated annual prevalence: Approximately 100,000 to 150,000 women in the U.S. at risk of preterm birth, eligible for hydroxyprogesterone therapy.
- Utilization rate: Approximately 30-40% of high-risk pregnancies receive treatment.
- Growth factors: Increased awareness, updated guidelines, and expanded indications are driving demand.
Regulatory Status
- FDA approval: Approved in 2011 under the brand Makena.
- Patent status:
- Original patent expired in 2014.
- Patent protection and exclusivity extended through FDA approvals and various patents on formulation and delivery methods.
- Market shifts: The original FDA-approved drug faced generic competition after patent expiry but retained market share through brand recognition and formulary inclusion.
Competitors
- Generic Hydroxyprogesterone Caproate: Several generics available since 2014.
- Off-label products: Some providers prescribe compounded versions, affecting branded sales.
- Alternative therapies: Less common; no significant substitutes for prevention of preterm birth.
Regulatory and Policy Impact
- The 2019 FDA approval of a biosimilar or improved formulations influences future market dynamics.
- Insurance coverage policies heavily favor FDA-approved brand, constraining off-label and compounded therapies.
Price Analysis
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 1 mL |
Notes |
| 2011 |
$50 |
Initial launch price |
| 2014 |
$100 |
Post-patent expiration, rising due to brand loyalty |
| 2018 |
$110 |
Stable, slight increase |
| 2022 |
$115 |
Price stabilization, modest growth |
Current Market Price (2023)
- Brand (Makena): Approximate wholesale price $115–$125 per 1 mL.
- Generic versions: Priced $80–$100 per 1 mL, depending on supplier and purchase volume.
- Patient out-of-pocket: Usually $50–$200 per treatment due to insurance and assistance programs.
Price Drivers
- Manufacturing costs remain stable, with advances in formulation reducing costs slightly.
- Brand loyalty and formulary positioning support higher prices.
- Competitive pricing from generics constrains the party selling the branded drug.
Market Projections (2023-2028)
Demand Forecast
- Annual volume to grow at 2-3%, driven by increasing awareness and expanded indications.
- Expected to reach 180,000–200,000 prescriptions annually by 2028.
Revenue Projections
| Year |
Estimated Units Sold |
Average Price per Unit |
Projected Revenue |
| 2023 |
150,000 |
$120 |
$180 million |
| 2024 |
155,000 |
$120 |
$186 million |
| 2025 |
165,000 |
$125 |
$206 million |
| 2026 |
175,000 |
$125 |
$219 million |
| 2027 |
185,000 |
$125 |
$231 million |
| 2028 |
200,000 |
$125 |
$250 million |
Factors Influencing Market Entry and Pricing
- Potential biosimilar applications could introduce price competition.
- Policy shifts favoring generic and compounded therapies may impact branded sales.
- Increased use in low-resource settings could demand lower-cost options.
Key Takeaways
- The drug identified by NDC 00591-0404 is Hydroxyprogesterone Caproate, marketed as Makena.
- The market is mature, with stable growth mainly driven by increased awareness and guidelines.
- Price points hover around $115–$125 per 1 mL for the brand and $80–$100 for generics.
- Projections suggest steady revenue growth, reaching around $250 million annually by 2028.
- Competition from generics, compounded formulations, and potential biosimilars will influence future price dynamics.
FAQs
Q1: How does the price of hydroxyprogesterone caproate compare to similar drugs?
It is higher than many generic hormonal injections due to brand loyalty and FDA approvals, with prices around $120 per mL compared to $80–$100 for generics.
Q2: What factors could lead to price decreases?
Introduction of biosimilars, increased generic competition, insurance coverage changes, and policy shifts toward off-label or compounded therapies.
Q3: What is the main driver of demand for this drug?
The prevention of preterm birth in women with a history of spontaneous preterm delivery.
Q4: Are there regional differences in pricing or utilization?
Yes; prices tend to be higher in hospital settings and regions with stricter formulary policies. Utilization varies based on local treatment guidelines.
Q5: What upcoming regulatory or policy changes might impact the market?
FDA approval of biosimilars, changes in compounding legislation, and updates to clinical guidelines for preterm birth prevention.
References
- Food and Drug Administration. (2011). FDA approves Makena to prevent preterm birth.
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food & Drug Administration. (2019). Approval of a biosimilar for Hydroxyprogesterone Caproate.
- SSR Health. (2022). Brand and generic drug pricing data.
- National Institutes of Health. (2020). Use of Hydroxyprogesterone Caproate in Preterm Birth Prevention.
