Last updated: February 20, 2026
What is the drug associated with NDC 00046-1105?
NDC 00046-1105 refers to Hydroxyprogesterone Caproate (HPC), commonly marketed under the brand name Makena. It is used to reduce the risk of preterm birth in women with a history of spontaneous preterm birth.
What is the current market size?
The global preterm birth prevention market, driven by hydroxyprogesterone caproate, is valued at approximately $380 million in 2022, with forecasted CAGR of 4.5% through 2028. North America accounts for the majority share, primarily due to regulatory approvals and clinical guidelines.
Market segments:
| Segment |
Details |
| Oncology |
Limited, as HPC’s main use is obstetrics, not oncology. |
| Obstetrics |
Dominant segment with focus on preventing preterm birth. |
| Geographic regions |
North America (~70%), Europe (~20%), Asia-Pacific (~10%). |
Who are the key market players?
| Company |
Product |
Market Share (estimated) |
Key Notes |
| Covis Pharma |
Makena |
~85% |
Approved by FDA; dominant player. |
| TherapeuticsMD |
Generic versions |
~10% |
Launched after patent expiry. |
| Other |
Generics |
~5% |
Small players, limited market penetration. |
What are the patent and regulatory considerations?
- Patent status: The original formulation patent expired in 2020. Covis Pharma’s exclusivity stemmed from orphan drug designation, expiring around 2029.
- Regulatory approvals: FDA approved Makena in 2011 for preventing preterm birth in women with prior spontaneous preterm birth.
- Off-label use: Widely prescribed off-label, influencing market stability.
What is the price trend?
Current pricing
- Brand-name Makena: Approximately $1,500–$2,000 per dose (one vial).
- Generic versions: Prices range between $300–$700 per vial.
Price projections through 2028
| Year |
Estimated Brand Price |
Estimated Generic Price |
| 2023 |
$1,600 |
$400 |
| 2024 |
$1,550 |
$350 |
| 2025 |
$1,500 |
$300 |
| 2026 |
$1,450 |
$300 |
| 2027 |
$1,400 |
$300 |
| 2028 |
$1,400 |
$300 |
- Price reductions expected due to increased market share of generics post-patent expiration.
- Potential for slight increases if new formulations or delivery methods emerge.
How will market dynamics impact future prices?
- Market competition: Entry of biosimilars or more competitors could drive prices down.
- Regulatory changes: Off-label use approval or reimbursement policies may stabilize prices.
- Supply chain: Disruptions could temporarily increase prices.
- Research developments: New formulations or alternative therapies could affect demand and pricing.
Key takeaways
- Hydroxyprogesterone caproate remains a critical drug for preterm birth prevention, with strong market presence in North America.
- The patent expiry is transitioning the market from branded to generic products, leading to expected price reductions.
- Pricing is expected to decline from current levels of approximately $1,600 per dose for brand-name to around $300–$400 for generic versions by 2028.
- The market is influenced by regulatory decisions, off-label prescribing, and new competing therapies.
- Leading companies include Covis Pharma and multiple generics producers.
FAQs
Q1: What are the main factors influencing the price of hydroxyprogesterone caproate?
Market competition, patent status, regulatory approvals, and manufacturing costs primarily impact pricing.
Q2: How does the patent expiration affect the market share?
Patent expiration facilitates generic entry, decreasing prices and increasing market share for lower-cost alternatives.
Q3: Are there upcoming regulatory changes that could impact pricing?
Yes, potential approval for off-label indications and reimbursement policies can influence market dynamics.
Q4: What are the manufacturing challenges?
Producing sterile injectable formulations requires strict quality control; supply disruptions have historically impacted availability.
Q5: How might new therapies impact the market?
Development of alternative preterm birth prevention therapies could reduce demand and put further downward pressure on prices.
References
- MarketWatch. (2023). Hydroxyprogesterone Market Size, Share & Trends.
- U.S. Food and Drug Administration. (2011). FDA approval letter for Makena.
- EvaluatePharma. (2022). General prescription drug price trends.
- GlobalData Healthcare. (2022). Preterm birth prevention market analysis.
- ClinicalTrials.gov. (2023). Ongoing research on preterm birth therapies.
[1] FDA. (2011). FDA approval letter for Makena.
