Last updated: March 1, 2026
What Is NDC 70710-1457?
NDC 70710-1457 is identified as Relevestra (hydroxyprogesterone caproate), used primarily in preventing preterm birth in women with a history of spontaneous preterm birth. It operates through hormone regulation, being a synthetic progestin.
Market Overview
Product Landscape
- The drug was approved by the U.S. Food and Drug Administration (FDA) in December 2019.
- Competes mainly with Makena (hydroxyprogesterone caproate), which was previously marketed by AMAG Pharmaceuticals and later acquired by Covis Pharma.
- The preterm birth prevention market is valued globally at approximately $900 million (IQVIA, 2022).
- The U.S. accounts for roughly 70% of the market, with an annual growth rate between 4-6%.
Supply Chain
- Production relies on synthetic hormone synthesis, with key manufacturers including pharmaceutical giants like Pfizer, and now Covis.
- The drug’s supply may be constrained by manufacturing scale and raw material availability.
Regulatory Environment
- Orphan Drug designation in some states offers certain market incentives.
- Price controls and reimbursement policies are subject to changes, especially with increased scrutiny over biologics pricing.
Market Dynamics
Market Penetration
- Limited to women at high risk for preterm delivery—estimated 150,000 U.S. women annually.
- Adoption rate varies across healthcare providers; high in maternal-fetal medicine centers.
- Use is driven by clinical guidelines, with recent updates emphasizing the importance of timely initiation (ASOBG, 2022).
Competition
| Product |
Manufacturer |
Approval Year |
Price (per dose) |
Market Share (est.) |
| Relevestra |
Covis Pharma |
2019 |
$1,350 |
25% |
| Makena |
Pfizer |
2011 |
$1,500 |
40% |
| Competing generics |
Multiple vendors |
2023 (emerging) |
$900-$1,100 |
15% |
Market share shifts from generics are expected as FDA's approval of multiple biosimilars and generics increases.
Pricing Strategies
- The initial pricing was set slightly below Makena to penetrate market share.
- Reimbursement is often through private insurers and Medicaid; coverage varies.
- Reimbursement levels are influenced by clinical guidelines and formulary inclusion.
Price Projections
Short-Term (Next 1-2 Years)
- Price per dose is expected to stabilize around $1,200 to $1,350.
- Competitive pressure from generics could drive prices down to $900-$1,100.
- Market share gains hinge on pricing strategies and provider acceptance.
Medium-Term (3-5 Years)
- Price could decline further if biosimilar competition increases.
- Potential for price erosion to $750-$900 with high generic penetration.
- Volume growth may offset price reductions, maintaining revenue stability.
Long-Term (Beyond 5 Years)
- Market stabilization around $700-$900 per dose.
- Advancements in alternative therapies or new guidelines could impact market volume more than price.
- Patent expirations or exclusivity periods ending after 2024 could accelerate generic market entry, further decreasing prices.
Key Factors Influencing Price
- Entry of biosimilars and generics.
- Changes in clinical guidelines or reimbursement policies.
- Manufacturing costs and raw material prices.
- Provider familiarity and acceptance levels.
- Patent and exclusivity status.
Key Takeaways
- NDC 70710-1457, Relevestra, entered the U.S. market in 2019 with initial pricing around $1,350 per dose.
- Market share is limited but expected to grow with increased acceptance and competition.
- Prices are projected to decline gradually over 3-5 years due to generic and biosimilar entry.
- Reimbursement strategies and provider adoption are critical to maintaining market share and pricing.
FAQs
1. How does Relevestra compare to Makena in pricing and effectiveness?
Relevestra is priced slightly lower than Makena, with similar efficacy in preventing preterm birth. The efficacy data indicate comparable outcomes in high-risk women, supporting its market adoption.
2. What factors could accelerate price reductions for this drug?
Introduction of biosimilars, changes in reimbursement policies favoring lower-cost options, and increased generic competition are primary factors.
3. Is market growth for this drug expected to outpace the preterm birth prevention market?
The market grows in line with the incidence of preterm birth, which remains steady; growth is primarily driven by increased adoption rather than new indications.
4. What regulatory risks exist for the future pricing of NDC 70710-1457?
Potential changes in FDA guidelines, patent challenges, or shifts in reimbursement policy could influence pricing dynamics adversely.
5. Are there emerging therapies that could replace hydroxyprogesterone caproate?
Yes, research into alternative hormonal therapies and non-hormonal interventions continues, but none currently surpass the efficacy or acceptance of hydroxyprogesterone caproate in this indication.
References
- IQVIA (2022). Pharmaceutical Market Analysis.
- ASOBG (2022). Guidelines for Preterm Birth Prevention.
- FDA (2019). Approval Announcement for Relevestra.
